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 A Comparison of Ranibizumab and Aflibercept for the Development of Geographic Atrophy in (Wet) AMD Patients (NCT02130024), a randomized phase 4 study. The primary outcome is Mean Change in Square-root Area of Geographic Atrophy (GA) From Baseline to Month 24.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02130024 |
| Phase | Phase 4 |
| Condition | Age-Related Macular Degeneration |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 281 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Novartis Pharmaceuticals |
| Results posted | Yes |
2. Clinical Question
Population
Patients with neovascular (wet) age-related macular degeneration were eligible for the comparison. The registry record lists age-related macular degeneration as the condition and describes the primary analysis population as randomized patients with at least one post-baseline efficacy value for the primary endpoint. The primary measure came from one study eye per patient. The record lists enrollment as 281; it does not give a separate count of patients contributing to the primary analysis.
Intervention
One randomized group received ranibizumab 0.5 mg. The regimen began with monthly loading doses at Baseline, Week 4, and Week 8, then continued with individualized treatment and evaluation according to disease activity using a treat-and-extend approach.
Comparator
The other randomized group received aflibercept 2.0 mg. Its listed regimen also began with monthly loading doses at Baseline, Week 4, and Week 8, followed by individualized treatment and evaluation according to disease activity using a treat-and-extend approach. The registry record does not report the allocation ratio.
Primary question
The trial sought to compare mean change in the square-root-transformed area of geographic atrophy from baseline to Month 24. Geographic atrophy is described in the registry summary as an advanced form of age-related macular degeneration that can result in progressive and irreversible loss of visual function. The registry record does not provide a single reduced numerical comparison for the primary outcome, so the size and precision of the difference between treatment groups cannot be assessed from a single estimate.
3. Trial Design
This was a Phase 4, randomized, single-masked, parallel-group trial comparing ranibizumab 0.5 mg with aflibercept 2.0 mg in patients with neovascular age-related macular degeneration. The registry lists enrollment as 281 and the study status as completed. It records the study start as 2014-04-11 and primary completion as 2017-11-15. The identity of the people who were masked is not reported in the registry record, nor is the allocation ratio.
Both treatment groups had the same described dosing structure: monthly loading doses at Baseline, Week 4, and Week 8, followed by individualized treatment and evaluation according to disease activity through a treat-and-extend regimen. That common structure makes the randomized treatment assignment the central planned contrast, while subsequent treatment timing could vary according to disease activity. The registry record does not provide further details of how those individualized decisions were made.
The primary endpoint was mean change in square-root-transformed geographic atrophy area from baseline to Month 24. Trained study-site personnel obtained multimodal eye images and sent them to an independent Central Reading Center for measurement. Area was treated as zero when geographic atrophy was reported as absent. One study eye contributed to the primary analysis.
The stated primary analysis population was the FAS: randomized patients with at least one post-baseline efficacy value for the primary endpoint. Patients were analyzed according to the treatment regimen assigned at randomization, following the intent-to-treat principle, with no imputation for missing data. The registry record does not report further details of the statistical analysis plan, the masking procedures, or the handling of specific deviations from the assigned regimen.
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 reporting group includes all patients randomized to treatment.
Overall Study
| Stage | Ranibizumab 0.5 mg | Aflibercept 2.0 mg |
|---|---|---|
| STARTED | 142 | 139 |
| Safety Set | 141 | 139 |
| Full Analysis Set (FAS) | 141 | 137 |
| COMPLETED | 117 | 108 |
| NOT COMPLETED | 25 | 31 |
Reasons for not completing this period:
| Reason | Ranibizumab 0.5 mg | Aflibercept 2.0 mg |
|---|---|---|
| Adverse Event | 10 | 11 |
| Death | 2 | 2 |
| Lost to Follow-up | 1 | 1 |
| Physician Decision | 1 | 3 |
| Protocol Deviation | 4 | 0 |
| Site Administration Problems | 1 | 0 |
| Subject Withdrew Consent | 6 | 14 |
Analysis population for the primary outcome, as defined in the registry: All randomized patients with at least one post-baseline efficacy value for the primary endpoint (FAS). Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization, with no imputation for missing data.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: All patients randomized to treatment
| Characteristic | Unit | Ranibizumab 0.5 mg | Aflibercept 2.0 mg | Total |
|---|---|---|---|---|
| Participants analysed | 142 | 139 | 281 | |
| Age, Continuous | years | 76.6 (SD 8.5) | 78.7 (SD 7.45) | 77.7 (SD 8.06) |
| Sex: Female, Male: Female | Participants | 72 | 76 | 148 |
| Sex: Female, Male: Male | Participants | 70 | 63 | 133 |
| Race/Ethnicity, Customized: Caucasian | participants | 132 | 130 | 262 |
| Race/Ethnicity, Customized: Black African | participants | 0 | 1 | 1 |
| Race/Ethnicity, Customized: Asian | participants | 8 | 7 | 15 |
| Race/Ethnicity, Customized: Other | participants | 2 | 1 | 3 |
6. Primary Endpoint
The registry lists the primary outcome as Mean Change in Square-root Area of Geographic Atrophy (GA) From Baseline to Month 24, measured over Baseline, Month 24.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | mm |
| Endpoint classification | Continuous Endpoint |
The primary endpoint was mean change from baseline to Month 24 in the square-root-transformed area of geographic atrophy, measured in mm. Geographic atrophy was assessed from multimodal eye images. Trained study-site personnel obtained the images, and an independent Central Reading Center measured the area. If geographic atrophy was reported as absent, its area was treated as zero. One study eye contributed to the analysis.
This endpoint measures structural change in the eye rather than visual function itself. The registry describes geographic atrophy as an advanced form of age-related macular degeneration that can result in progressive and irreversible loss of visual function. Measuring its area therefore addresses the trial’s stated question about the development of new geographic atrophy, while remaining distinct from a direct measure of vision.
The square-root transformation means the analyzed measure was not the raw area scale. In general, a transformation changes how differences across the range of measurements are represented and can make a skewed measure more suitable for statistical analysis. The registry record does not state why this transformation was selected or provide the underlying raw-area results. It also does not report a single reduced numerical primary comparison, so the endpoint definition alone does not establish the direction, magnitude, or precision of any treatment-group difference.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies the primary outcome as mean change in square-root-transformed geographic atrophy area between baseline and Month 24. It also indicates that the primary outcome has several categories or time points and was not reduced to one comparison. Consequently, the registry record does not report a single primary estimate that can be interpreted as the treatment-group difference, and no numerical estimate or confidence interval for such a comparison is reported in the registry record.
Without a reported estimate and measure of uncertainty, the magnitude and precision of any contrast between ranibizumab and aflibercept cannot be assessed from the registry record. A mean change is a group-level summary: it describes the average change for the analyzed population, not the experience of every participant. In general, a confidence interval conveys uncertainty around an estimated effect. The registry record does not give a confidence interval or p-value for a single reduced primary comparison, so neither can be used to characterize that comparison.
The analysis population is described as randomized patients with at least one post-baseline efficacy value for the primary endpoint. Assignment at randomization was retained for analysis, and missing data were not imputed. These are important features for interpreting the intended comparison, but they do not by themselves establish that missing outcomes were unrelated to treatment or outcome. The registry record does not report the amount or pattern of missing primary-endpoint data, or sensitivity analyses addressing missingness.
The record lists secondary outcomes including geographic atrophy occurrence during the overall 24 months, changes in visual acuity and central subfield foveal thickness, injection counts, fluid status, and specified visual-acuity gain or loss categories. Their presence indicates that the trial collected or planned to report several types of information, but their outcome values are not included in the record. Those outcomes should not be substituted for the primary measure or treated as evidence of a primary treatment-group difference.
Overall, the registry record establishes the randomized comparison, endpoint definition, and analysis population, but does not provide the numerical primary result needed to judge its magnitude or precision. It therefore supports a description of what was intended to be measured, not a conclusion about which treatment had a larger or smaller mean change.
9. Statistical Methods Explained
The study used a randomized, parallel-group design. Randomization assigns participants to treatment groups by chance, which is intended to reduce systematic differences between groups at the start of a trial. In general, a randomized comparison can support a more credible assessment of treatment-group differences than a comparison in which treatment choice is determined by participant or clinician characteristics. Randomization does not guarantee that groups are identical in every respect, and the registry record does not report the allocation ratio or the method used to generate or conceal assignments.
What does single masking mean?
The registry describes the trial as single-masked. Masking is intended to limit the influence of knowledge about treatment assignment on trial conduct, outcome assessment, or reporting. The term alone does not identify who was masked. The identity of the masked party and the practical masking procedures are not reported in the registry record. The primary outcome involved image measurement by an independent Central Reading Center, but the record does not say whether its readers were masked to treatment assignment.
What does the primary measure represent?
The outcome is a continuous measure summarized as a mean: change in square-root-transformed geographic atrophy area from baseline to Month 24. A mean describes the average observed value in a group. A mean difference between groups would describe the average contrast, but the registry record does not report a single reduced primary comparison. The scale is in mm after square-root transformation, rather than an untransformed area scale. In general, transformations alter the scale and distribution of data; they can be used when the original measurement has features that make direct modeling less suitable. The trial’s stated reason for choosing this transformation is not reported in the registry record.
Images were obtained by trained study-site personnel and sent to an independent Central Reading Center for measurement. Centralized assessment can promote consistency by applying a common reading process across sites. That general rationale does not establish that measurement was free of error. The registry record does not describe image-quality rules, reader agreement, or procedures for resolving measurement disagreements. It states that an absent finding was assigned an area of zero, an important rule for interpreting the measured outcome.
How should the analysis population be understood?
The primary analysis population is described as all randomized patients with at least one post-baseline efficacy value for the primary endpoint, identified as the FAS. The record says patients were analyzed according to the treatment regimen assigned at randomization, following the intent-to-treat principle. Retaining randomized assignment avoids redefining groups according to treatment received after randomization. However, requiring at least one post-baseline value means that participants without such a value are not included in the stated endpoint population. The registry record does not report how many patients lacked a qualifying value.
The record specifies no imputation for missing data. Imputation is a statistical procedure for assigning or estimating values that were not observed. In general, an analysis without imputation uses the available outcome measurements rather than replacing missing values with modeled or assumed values. This does not resolve the potential for bias if the likelihood of a missing value is related to the unobserved outcome or treatment group. The amount, reasons, and distribution of missing endpoint values, as well as sensitivity analyses, are not reported in the registry record.
What do variability and uncertainty summaries tell readers?
The primary endpoint is described as a mean with standard deviation. A standard deviation describes how spread out individual measurements are around a group mean; it is not the same as the uncertainty in the estimated mean or in a treatment-group contrast. In general, a confidence interval around a contrast communicates uncertainty about its estimated value, while a p-value addresses compatibility with a specified null hypothesis under a statistical model. The registry record does not report a single reduced primary contrast, its confidence interval, or its p-value. The standard deviation alone would not supply those missing pieces.
Over-dispersion is a general issue when observed variability is greater than a statistical model expects. It can make standard errors too small and uncertainty statements too optimistic if the model does not accommodate the additional variation. The registry record does not identify an over-dispersion adjustment or describe the statistical model used for the primary endpoint, so no claim about such an adjustment can be made. More broadly, the detailed statistical plan, model assumptions, covariate adjustments, and any interim analyses are not reported in the registry record.
What can planning calculations establish?
In general, a sample-size calculation is a planning exercise about the amount of information needed to detect a specified effect under stated assumptions. It is not evidence that a trial achieved that effect or that its observed result was adequately powered. The registry’s sample-size assumptions describe an illustration using a two-sided significance level of 0.05, equal allocation, a normal approximation, and a target effect expressed as a stated fraction of an observed effect. For non-time-to-event outcomes, such illustrations are expressed as participants per arm; time-to-event illustrations use total events. These assumptions do not constitute the trial’s own design justification, which is not reported in the registry record. The primary result is not reduced to one comparison in the record, so a single primary effect estimate cannot be used to characterize the observed treatment contrast.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 14 outcome measures and 20 analyses. The primary outcome is not reduced to one comparison because it has several categories or time points. The record also lists multiple secondary outcomes, including geographic atrophy occurrence over the overall 24 months, visual acuity, central subfield foveal thickness, injection counts, fluid status, and visual-acuity gain and loss categories. Multiple outcomes and analyses create a multiplicity issue: when many hypotheses are examined, the chance of at least one apparently unusual result can increase. In general, a prespecified testing strategy can address this concern by defining which outcomes are primary, how comparisons are ordered, or whether error rates are adjusted. The statistical plan for multiplicity is not reported in the registry record.
The primary analysis population includes randomized patients with at least one post-baseline efficacy value. The record says participants were analyzed according to randomized assignment and that missing data were not imputed. It does not report how many primary endpoint values were missing, why they were missing, or whether missingness differed between groups. Those details matter because an available-value analysis can be affected if missing outcomes are related to treatment or to the unobserved outcome.
The registry record does not report sensitivity analyses for missing data, a detailed model specification, interim analyses, or a complete statistical plan. Without those details, readers cannot determine how the investigators assessed the robustness of the primary analysis or controlled interpretation across the listed outcomes. The stated population and no-imputation approach are useful to know, but they do not answer those additional questions.
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 |
|---|---|---|---|
| Ranibizumab 0.5 mg | 50 | 141 | 35.5% |
| Aflibercept 2.0 mg | 58 | 139 | 41.7% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Ranibizumab 0.5 mg | 3 of 141 |
| Aflibercept 2.0 mg | 6 of 139 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 2% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Ranibizumab 0.5 mg | 122 of 141 |
| Aflibercept 2.0 mg | 123 of 139 |
Most frequent serious adverse event terms
| Event term | Organ system | Ranibizumab 0.5 mg | Aflibercept 2.0 mg |
|---|---|---|---|
| Basal cell carcinoma (Non-ocular) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 7 of 141 | 2 of 139 |
| Pneumonia (Non-ocular) | Infections and infestations | 4 of 141 | 4 of 139 |
| Squamous cell carcinoma (Non-ocular) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 4 of 141 | 4 of 139 |
| Atrial fibrillation (Non-ocular) | Cardiac disorders | 7 of 141 | 0 of 139 |
| Urinary tract infection (Non-ocular) | Infections and infestations | 2 of 141 | 4 of 139 |
| Chest pain (Non-ocular) | General disorders | 3 of 141 | 2 of 139 |
| Femoral neck fracture (Non-ocular) | Injury, poisoning and procedural complications | 3 of 141 | 2 of 139 |
| Syncope (Non-ocular) | Nervous system disorders | 3 of 141 | 2 of 139 |
| Renal failure acute (Non-ocular) | Renal and urinary disorders | 3 of 141 | 2 of 139 |
| Fall (Non-ocular) | Injury, poisoning and procedural complications | 3 of 141 | 1 of 139 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Ranibizumab 0.5 mg | Aflibercept 2.0 mg |
|---|---|---|---|
| Chest X-ray (Non-ocular) | Investigations | 14 of 141 | 20 of 139 |
| Eye pain (Right eye) | Eye disorders | 14 of 141 | 13 of 139 |
| Urinary tract infection (Non-ocular) | Infections and infestations | 11 of 141 | 15 of 139 |
| Fall (Non-ocular) | Injury, poisoning and procedural complications | 11 of 141 | 15 of 139 |
| Eye pain (Left eye) | Eye disorders | 10 of 141 | 15 of 139 |
| Age-related macular degeneration (Right eye) | Eye disorders | 10 of 141 | 14 of 139 |
| Computerised tomogram (Non-ocular) | Investigations | 6 of 141 | 18 of 139 |
| Nasopharyngitis (Non-ocular) | Infections and infestations | 15 of 141 | 8 of 139 |
| Dry eye (Both eyes) | Eye disorders | 13 of 141 | 9 of 139 |
| Computerised tomogram head (Non-ocular) | Investigations | 11 of 141 | 11 of 139 |
Serious events with the highest arm-level rate: atrial fibrillation (non-ocular) (5.0%), basal cell carcinoma (non-ocular) (5.0%), pneumonia (non-ocular) (2.9%), urinary tract infection (non-ocular) (2.9%), squamous cell carcinoma (non-ocular) (2.9%).
The registry reports serious adverse event counts by treatment group, with a corresponding number at risk: 50 of 141 for ranibizumab 0.5 mg and 58 of 139 for aflibercept 2.0 mg. These are group-level registry figures. They do not by themselves describe the timing, duration, severity distribution, or causal relationship of events to treatment. The record also lists other adverse event counts: 122 of 141 for ranibizumab 0.5 mg and 123 of 139 for aflibercept 2.0 mg. The registry reports 3 deaths in the ranibizumab group and 6 in the aflibercept group. The record does not establish that deaths or adverse events were caused by the assigned treatment.
The listed serious adverse event terms and percentages are atrial fibrillation (Non-ocular), 5.0%; basal cell carcinoma (Non-ocular), 5.0%; pneumonia (Non-ocular), 2.9%; urinary tract infection (Non-ocular), 2.9%; squamous cell carcinoma (Non-ocular), 2.9%; and cerebrovascular accident (Non-ocular), 2.2%. The registry excerpt does not identify a treatment group for each term, so these percentages should not be assigned to one group. They also do not establish comparative risk. Safety comparisons require attention to event definitions, follow-up, exposure, and uncertainty, details not fully reported in the registry record.
12. What the Result Does, and Does Not, Mean
This trial’s stated question was whether mean change in square-root-transformed geographic atrophy area from baseline to Month 24 differed between randomized groups receiving ranibizumab 0.5 mg or aflibercept 2.0 mg. The registry describes the common loading-dose schedule, the later individualized treat-and-extend approach, centralized image measurement, and the analysis population. Those details clarify what comparison was planned and how the primary endpoint was defined.
The registry record does not report a single reduced primary comparison or its numerical result. Therefore, it does not establish the direction or magnitude of a treatment-group difference in the endpoint, nor how precisely such a difference was estimated. No numerical primary estimate, confidence interval, or p-value for one reduced comparison is reported in the registry record. The absence of a single reported contrast is not evidence that the groups had identical outcomes; it means the record does not furnish the reduced result needed to make that assessment.
The endpoint is a structural measure of geographic atrophy area, not a direct measure of visual function. Although the registry summary describes geographic atrophy as a condition that can result in progressive and irreversible loss of visual function, a change in the measured area should not be treated as equivalent to a measured change in vision. The registry lists visual acuity and other secondary outcomes, but their numerical results are not reported in the record.
Randomization and analysis according to assigned treatment are relevant strengths of the planned comparison. At the same time, the primary population was limited to randomized patients with at least one post-baseline efficacy value, and missing data were not imputed. The record does not report the extent or pattern of missingness or sensitivity analyses. These limitations leave uncertainty about how missing outcomes could affect the analysis.
The safety counts are descriptive registry figures. They do not establish causation or provide a complete comparative assessment of risk. Overall, the record documents a clinical-trial question and its measurement approach, but it does not support a conclusion that one treatment produced greater or lesser geographic atrophy change.
13. Why This Trial Matters Statistically
This trial raises several statistical issues that matter when interpreting clinical research. Its randomized, parallel-group design defines a direct treatment comparison, and the intent-to-treat approach described in the registry retains participants in the groups to which they were assigned. Those design features help clarify the intended contrast, but they cannot replace an actual estimate of that contrast.
The primary endpoint is a continuous measurement assessed through images and summarized as mean change. The record specifies centralized measurement, a square-root transformation, and a rule assigning zero area when geographic atrophy was absent. Each choice affects what the endpoint represents and how readers should understand its scale. The transformation means that the analyzed outcome is not raw area, while the absent-disease rule places zero values within the outcome definition.
The analysis population and missing-data approach also affect interpretation. The stated population requires at least one post-baseline endpoint value, and no imputation was used. Without information about the amount and pattern of missingness, readers cannot assess how much these choices may influence the result. A complete statistical plan would also help readers understand model assumptions, adjustment decisions, and how the multiple listed outcomes and analyses were handled.
Most importantly, the registry record does not reduce the primary outcome to one comparison or report a numerical primary result. A well-defined endpoint and randomized design do not alone show the size, direction, or precision of an observed effect. This distinction is central to evidence interpretation: design describes how a comparison was intended to work, while results are needed to quantify what the comparison found. The record therefore supports close examination of endpoint definition and analysis choices, but not a numerical judgment about the primary treatment contrast.
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 the primary outcome is that the registry record does not provide a single reduced comparison or its numerical estimate. Although the endpoint is described as mean change in square-root-transformed geographic atrophy area from baseline to Month 24, the primary outcome has several categories or time points and was not reduced to one comparison. The record therefore does not report the magnitude, direction, or precision of a single primary contrast.
The primary analysis population includes randomized patients with at least one post-baseline efficacy value. The record specifies no imputation for missing data but does not report the amount, timing, or reasons for missing primary endpoint values. It also does not report sensitivity analyses that could show whether conclusions were robust to assumptions about missing outcomes.
Details of the statistical analysis plan are limited. The record does not report the model specification, covariate adjustments, multiplicity strategy, interim analyses, or rationale for the square-root transformation. It identifies single masking but does not say who was masked or whether central image readers were masked. It also does not provide the allocation ratio.
The endpoint is based on one study eye and measures geographic atrophy area rather than visual function. The record lists several secondary outcomes, but their numerical results are not included in the described registry information. Serious and other adverse event counts are reported, but the record does not provide enough detail to establish causality or make a complete comparative safety assessment. These limits constrain interpretation of both efficacy and safety from the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Comparison of Ranibizumab and Aflibercept for the Development of Geographic Atrophy in (Wet) AMD Patients — NCT02130024.
- Registry record last updated 2019-06-05; status last verified 2018-10.
- Results first posted 2019-06-05.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry describes a completed Phase 4 randomized, single-masked, parallel-group comparison of ranibizumab 0.5 mg and aflibercept 2.0 mg in patients with neovascular age-related macular degeneration. Enrollment is listed as 281. Both groups followed a schedule of loading doses at Baseline, Week 4, and Week 8, followed by individualized treat-and-extend treatment and evaluation according to disease activity.
The primary endpoint was mean change in square-root-transformed geographic atrophy area from baseline to Month 24, assessed from images measured by an independent Central Reading Center. The primary analysis population comprised randomized patients with at least one post-baseline efficacy value; participants were analyzed by assigned treatment, with no imputation for missing data.
The registry record does not reduce the primary outcome to one comparison or report a numerical primary result. It lists secondary outcomes and adverse event figures, but the available information does not establish a numerical primary treatment contrast or a causal interpretation of safety events.