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 Evaluate the Efficacy and Safety of Fasinumab in Patients With Moderate-to-Severe Chronic Low Back Pain and Osteoarthritis of the Hip or Knee (NCT03285646), a randomized phase 3 study. The primary outcome is Change From Baseline to Week 16 in the Average Daily Low Back Pain Intensity (LBPI) Numeric Rating Scale (NRS) Score.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03285646 |
| Phase | Phase 3 |
| Condition | Chronic Low Back Pain, Osteoarthritis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 63 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Regeneron Pharmaceuticals |
| Results posted | Yes |
2. Clinical Question
Population
Participants had moderate-to-severe, non-radicular chronic low back pain and a clinical diagnosis of osteoarthritis of the hip or knee. The registry record reports enrollment of 63 participants. The primary endpoint population is described as participants evaluable for that endpoint; the number included in that population is not reported in the registry record.
Intervention
Fasinumab was given by subcutaneous injection every 4 weeks. The arm description identifies the dose as 3 mg. The study objective was to evaluate fasinumab for up to 16 weeks, including its effect on low back pain and its safety and tolerability.
Comparator
The comparator was matching placebo, given subcutaneously every 4 weeks. The study was randomized, placebo-controlled, and parallel-group, with quadruple masking recorded. The registry record does not describe the allocation sequence or the specific roles covered by the masking label.
Primary question
The primary endpoint was change from baseline to Week 16 in average daily low back pain intensity, measured with an 11-point numeric rating scale. The study asked whether the average change differed between participants assigned to fasinumab and those assigned to placebo. Numerical group results and a statistical comparison for this endpoint are not reported in the registry record, so the treatment contrast cannot be quantified from the posted results.
3. Trial Design
This was a Phase 3, randomized, double-blind, placebo-controlled, parallel-group study with quadruple masking recorded. It enrolled participants with moderate-to-severe chronic low back pain and osteoarthritis of the hip or knee. The brief study description specifies non-radicular chronic low back pain. Enrollment was 63. The registry record lists Regeneron Pharmaceuticals as the sponsor and records the study as terminated.
Participants were assigned to fasinumab or matching placebo. The fasinumab arm is described as 3 mg by subcutaneous injection every 4 weeks; placebo was also administered subcutaneously every 4 weeks. The intended treatment period described in the study objectives was up to 16 weeks. The primary assessment concerned change in average daily low back pain intensity from baseline to Week 16, while the recorded assessment time frame also names Week 1, Week 2, Week 4, Week 8, and Week 12.
The registry lists additional outcomes covering disability, patient global assessment of low back pain, pain interference, a threshold reduction in average daily pain, adjudicated arthropathy events, treatment-emergent adverse events, and sympathetic nervous system dysfunction events. It also describes objectives related to safety and tolerability, serum fasinumab concentrations, and immunogenicity. These objectives indicate the range of questions the study set out to examine, but do not establish what the results were.
The registry record does not report the reasons for termination, the allocation procedure, the planned number of participants, or the protocol’s sample-size justification. It also does not report the numbers assigned to each arm in the primary endpoint analysis. The safety summary gives arm-specific numbers at risk, but those figures should not be treated as a substitute for endpoint-specific analysis populations.
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: The study consisted of a screening period of up to 30 days and a 7 (+3 day) day pre-randomization period during which all pain medication except study-provided rescue medication was discontinued.
Overall Study
| Stage | Fasinumab-matching Placebo | Fasinumab 3 mg SC Q4W |
|---|---|---|
| STARTED | 32 | 31 |
| COMPLETED | 19 | 27 |
| NOT COMPLETED | 13 | 4 |
Reasons for not completing this period:
| Reason | Fasinumab-matching Placebo | Fasinumab 3 mg SC Q4W |
|---|---|---|
| Adverse Event | 1 | 0 |
| Withdrawal by Subject | 10 | 2 |
| Lost to Follow-up | 2 | 1 |
| Investigator/Sponsor Decision | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: Number of Participants analyzed = Participants evaluable for this endpoint
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 | Fasinumab-matching Placebo | Fasinumab 3 mg SC Q4W | Total |
|---|---|---|---|---|
| Participants analysed | 32 | 31 | 63 | |
| Age, Continuous | years | 57.7 (SD 9.88) | 60.0 (SD 10.52) | 58.8 (SD 10.18) |
| Sex: Female, Male: Female | Participants | 21 | 18 | 39 |
| Sex: Female, Male: Male | Participants | 11 | 13 | 24 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 | 3 | 4 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 31 | 28 | 59 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race/Ethnicity, Customized: White | Participants | 15 | 17 | 32 |
| Race/Ethnicity, Customized: Black or African American | Participants | 15 | 14 | 29 |
| Race/Ethnicity, Customized: American Indian or Alaska Native | Participants | 1 | 0 | 1 |
| Race/Ethnicity, Customized: Native Hawaiian or Other Pacific Islander | Participants | 1 | 0 | 1 |
| Average Daily Low Back Pain Intensity (LBPI) Numerical Rating Scale (NRS) Score | Score on a Scale | 6.66 (SD 1.475) | 6.81 (SD 1.338) | 6.73 (SD 1.400) |
6. Primary Endpoint
The registry lists the primary outcome as Change From Baseline to Week 16 in the Average Daily Low Back Pain Intensity (LBPI) Numeric Rating Scale (NRS) Score, measured over Week 1, Week 2, Week 4, Week 8, Week 12, Week 16.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | Score on a Scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint was change from baseline to Week 16 in average daily low back pain intensity, measured using an 11-point numeric rating scale. Participants rated their average low back pain during the past 24 hours from 0, meaning no pain, to 10, meaning worst possible pain. Higher scores indicate higher pain. The daily value for a nominal visit was defined as the average of non-missing daily ratings for the 7 days before and including that visit.
Change from baseline expresses how a participant’s score at follow-up differs from that participant’s starting score. Comparing the average change between randomized groups can help describe the difference in pain-score trajectories associated with assignment to the study arms. A mean is a summary of the observed scores, while the standard deviation describes variation among observations around that mean. These are general statistical interpretations; the registry record identifies the endpoint parameter as a mean and its dispersion as a standard deviation.
Pain intensity is the direct focus of this endpoint, while other listed outcomes address related but distinct topics such as disability, patient global assessment, and pain interference. The endpoint definition therefore clarifies what the primary measure represents, but it cannot establish a treatment effect by itself. Numerical baseline values, Week 16 group means, changes, standard deviations, and a between-group estimate are not reported in the registry record. The precision and direction of the primary comparison consequently cannot be described from the posted results.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the study’s clinical question and design, but does not report a numerical result for the primary endpoint. Although the primary measure and assessment schedule are described, no arm-level Week 16 change, between-group contrast, confidence interval, or p-value is reported in the registry record. The direction, size, and precision of the primary comparison therefore cannot be assessed from the posted results. The record’s status is terminated, but the reason for termination is not reported in the registry record and should not be inferred from that status alone.
The endpoint was defined as change from baseline in average daily low back pain intensity. It used an 11-point scale from 0, no pain, to 10, worst possible pain, with higher scores indicating higher pain. The primary objective was to compare fasinumab with placebo in participants with chronic low back pain and hip or knee osteoarthritis. Without outcome estimates, it is not possible to say whether the groups changed by different amounts or how uncertain any difference might be.
In general, a confidence interval describes a range of values compatible with an estimate under the model used. A narrow interval indicates greater statistical precision than a wide interval, though precision is not the same as clinical importance. A p-value, when reported, describes how compatible the observed data are with a specified null model; it does not measure the size or importance of an effect. These general concepts cannot be applied to this trial’s primary comparison without the relevant estimate and uncertainty statistics.
The safety summary records serious adverse events in both arms: 1 affected participant among 32 at risk in the fasinumab-matching placebo group and 2 among 31 at risk in the fasinumab group. It also records other adverse events in 14 of 32 and 4 of 31 participants, respectively, and records 0 deaths in each group. These are descriptive counts for the safety categories in the registry record. They do not by themselves establish whether an event was caused by treatment, and the small arm-specific counts do not supply a complete safety profile.
The registry also lists serious-event terms with percentages, including Breast cancer stage IV, Dizziness, Dyspnoea, and Osteoarthritis. The record does not provide the context needed to interpret each listed term beyond its appearance in the serious-event summary. No efficacy conclusion follows from the safety counts, and no clinical recommendation follows from the posted data. The principal statistical limitation is the absence of numerical results for the primary endpoint and the other listed outcomes.
9. Statistical Methods Explained
What does the primary measure summarize?
The endpoint is continuous: it records a numeric pain score and summarizes change from baseline to Week 16. The registry identifies the mean as the parameter and the standard deviation as the measure of dispersion. In general, the mean describes the average score or average change across observations. The standard deviation describes how spread out individual observations are around that mean; it is not the uncertainty of the mean itself. The uncertainty of a comparison is usually conveyed with an estimate and an interval or test result, but these numerical results are not reported in the registry record.
The daily pain score was defined using the non-missing daily ratings for the 7 days before and including a nominal visit. The scale ranged from 0, no pain, to 10, worst possible pain, and higher scores indicated higher pain. This definition helps specify what was summarized at each visit. It does not reveal how many daily entries were available for each participant, how missing daily ratings were handled beyond the definition, or how many participants contributed to the Week 16 endpoint.
Why compare randomized groups?
Random assignment is intended, in general, to make the groups comparable on average at the start of a trial. A comparison between randomized groups can then estimate the contrast associated with assignment to the study arms, subject to the conduct of the trial and the analysis. This study used a parallel-group design, with fasinumab and matching placebo administered on the same every-4-weeks schedule. The registry identifies randomization and masking, but does not report the allocation procedure or the detailed statistical model used for the primary analysis.
A treatment contrast for a continuous endpoint could be expressed as a difference between group mean changes. That is a general description of one possible summary, not a claim about the exact estimator used in this trial. The registry record does not report the contrast, its standard error, confidence interval, or p-value. It also does not report any adjustment variables or other model details. Accordingly, the numerical size and uncertainty of the primary comparison cannot be reconstructed from the record.
How should repeated assessment times be understood?
The primary endpoint description names assessments at Week 1, Week 2, Week 4, Week 8, Week 12, and Week 16, while the endpoint title identifies change from baseline to Week 16. Repeated measurements can describe how outcomes vary over time, but they also raise analytic questions: whether each visit is analyzed separately, whether the visits are modeled together, and which time point is the primary contrast. The registry record does not report the statistical approach to repeated measurements. It also does not report a set of visit-specific estimates that would support a description of the trajectory.
The record indicates that the primary outcome has several categories or time points and is not reduced to one comparison. This means a single numerical primary comparison is not available in the posted results. It would be inappropriate to select one visit or construct an unreported summary as if it were the prespecified result.
What do variability and precision mean?
In general, greater variability among participants can make a group mean less precise when the amount of information is otherwise similar. A confidence interval combines information about the estimate and its uncertainty; it is useful for seeing both the range of plausible contrasts and whether the data are compatible with effects of different sizes. A standard deviation alone is not a confidence interval and does not show whether a between-group difference is statistically distinguishable from no difference. Since the record does not report endpoint means, standard deviations, or a contrast, these ideas describe how such results would be interpreted rather than the result of this trial.
In general, over-dispersion means that observed variability is greater than a particular statistical model expects. It can make model-based uncertainty too small if it is not handled appropriately. The primary endpoint is a continuous mean outcome, and the registry record does not report whether over-dispersion was assessed or relevant to the chosen analysis. No claim about the use of a correction or alternative model can be made.
What does the planning illustration represent?
The planning assumptions describe a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation, with the target effect expressed as a fraction of the observed effect. For time-to-event outcomes, the described convention is total events; for other outcomes, it is participants per arm. These are planning assumptions, not evidence about the trial’s observed results. A sample-size illustration is not observed power and should not be read as a measure of how likely the trial was to detect its actual effect.
Because numerical primary outcome results are not reported in the registry record, the observed effect underlying an illustration cannot be evaluated from the record. The protocol’s own sample-size justification and any design assumptions beyond the listed planning assumptions are not reported in the registry record. Any planning figures should therefore be interpreted as illustrations conditional on their assumptions, not as the study’s original design rationale or as a substitute for the missing endpoint results.
Which analytic choices remain unknown?
The registry record does not report whether the primary analysis was adjusted, how repeated measurements were modeled, how missing Week 16 values were handled, or which analysis population was used beyond defining the endpoint population as participants evaluable for that endpoint. It does not report the number evaluable for the primary endpoint. The total enrollment of 63 does not establish the number analyzed at each visit or for each outcome. These distinctions matter because endpoint-specific participation can differ from overall enrollment, and analysis decisions can affect estimates and their uncertainty.
In general, statistical interpretation requires both the estimate and enough information to understand its uncertainty and the population contributing to it. For this study, the registry supplies endpoint definitions and design features but not numerical efficacy analyses. The methodological description can therefore clarify the concepts and identify what remains unknown; it cannot reproduce or replace a statistical analysis that is not reported.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists several secondary outcomes in addition to the primary pain-intensity endpoint. They cover disability, patient global assessment, pain reduction thresholds, pain interference, arthropathy events, treatment-emergent adverse events, and sympathetic nervous system dysfunction. When a study examines multiple outcomes, time points, or comparisons, the chance of at least one apparently unusual result can increase. In general, a prespecified multiplicity strategy can control that risk, but the statistical plan and any multiplicity adjustment are not reported in the registry record.
The primary endpoint description names multiple assessment times, and the record indicates that the outcome has several categories or time points rather than one reduced comparison. No numerical analysis is reported for the primary endpoint, and no analysis results are listed for the other outcomes. The record does not state whether interim analyses were planned or conducted, whether outcomes were hierarchically tested, or how secondary findings were intended to be interpreted.
Missing-data handling is also not reported in the registry record. The endpoint definition says the daily average uses non-missing daily scores, but this does not explain how missing visit-level outcomes were treated in the primary analysis. The record does not identify imputation methods, assumptions about missingness, sensitivity analyses, or rules for participants who discontinued treatment or follow-up.
The endpoint population is described as participants evaluable for that endpoint, but the number evaluable and the analysis-population definitions are not reported in the registry record. It is not stated whether analyses followed all randomized participants, only participants with evaluable endpoint data, or another population. Without those details and the numerical outcome results, readers cannot assess attrition, the effect of missing data, or the robustness of any treatment comparison.
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 |
|---|---|---|---|
| Fasinumab-matching Placebo | 1 | 32 | 3.1% |
| Fasinumab 3 mg SC Q4W | 2 | 31 | 6.5% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Fasinumab-matching Placebo | 0 of 32 |
| Fasinumab 3 mg SC Q4W | 0 of 31 |
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 |
|---|---|
| Fasinumab-matching Placebo | 14 of 32 |
| Fasinumab 3 mg SC Q4W | 4 of 31 |
Most frequent serious adverse event terms
| Event term | Organ system | Fasinumab-matching Placebo | Fasinumab 3 mg SC Q4W |
|---|---|---|---|
| Breast cancer stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0 of 32 | 1 of 31 |
| Dizziness | Nervous system disorders | 0 of 32 | 1 of 31 |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 0 of 32 | 1 of 31 |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | 1 of 32 | 0 of 31 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Fasinumab-matching Placebo | Fasinumab 3 mg SC Q4W |
|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | 4 of 32 | 3 of 31 |
| Upper respiratory tract infection | Infections and infestations | 4 of 32 | 1 of 31 |
| Back pain | Musculoskeletal and connective tissue disorders | 5 of 32 | 0 of 31 |
| Blood creatine phosphokinase increased | Investigations | 3 of 32 | 1 of 31 |
| Neck Pain | Musculoskeletal and connective tissue disorders | 2 of 32 | 1 of 31 |
| Peripheral swelling | General disorders | 2 of 32 | 0 of 31 |
| Cough | Respiratory, thoracic and mediastinal disorders | 2 of 32 | 0 of 31 |
Serious events with the highest arm-level rate: breast cancer stage iv (3.2%), dizziness (3.2%), dyspnoea (3.2%), osteoarthritis (3.1%).
The safety summary gives arm-specific numbers at risk and numbers affected. In the fasinumab-matching placebo group, 1 of 32 participants was reported in the serious adverse-event category, and 14 of 32 were reported in the other adverse-event category. In the fasinumab group, 2 of 31 participants were reported in the serious category, and 4 of 31 in the other category. The registry records 0 deaths in each group.
The serious-event terms listed with percentages are Breast cancer stage IV at 3.2%, Dizziness at 3.2%, Dyspnoea at 3.2%, and Osteoarthritis at 3.1%. These entries are registry summaries; the record does not provide enough detail to infer the cause, timing, severity beyond the serious-event classification, or treatment relationship for each event. The listed percentages should not be interpreted as evidence that an event was caused by fasinumab.
In general, safety counts are descriptive and depend on the follow-up period, event definitions, and the number of participants observed. Counts from groups of different sizes are not by themselves a causal comparison. The registry record does not report a complete event-level account or a statistical comparison of the safety categories. The figures should therefore be read as the posted counts, not as a definitive estimate of comparative risk.
12. What the Result Does, and Does Not, Mean
The registry record documents a randomized, masked, placebo-controlled study designed to evaluate fasinumab for chronic low back pain in participants who also had hip or knee osteoarthritis. It specifies the primary endpoint, the rating scale, the treatment schedule, and a range of secondary and safety outcomes. It also gives selected safety counts. These details describe the study question and some of the recorded data, but they do not establish the size or direction of an efficacy effect.
The primary endpoint’s numerical results are not reported in the registry record. Without the group changes and a between-group estimate, readers cannot determine from the posted results how much average daily pain changed in either arm, whether the groups differed, or how precise a difference might be. A missing numerical result is not evidence of no effect, nor is it evidence of benefit. The record’s terminated status does not explain why the study stopped or establish what the trial would have found if it had continued.
The safety counts show that adverse events were recorded in both groups, including serious events, and that the registry lists no deaths in either group. These descriptive data do not prove that treatment caused or prevented any event. They also do not provide a complete account of safety across all outcomes and follow-up.
In general, a trial result is most informative when readers can consider the estimated effect, its uncertainty, the analysis population, missing data, and the prespecified statistical approach together. Several of those elements are not reported in the registry record. The study’s design features may support a comparative question, but design alone cannot answer it. The defensible interpretation is limited to the study’s stated aims and the specific posted counts; efficacy and comparative safety conclusions cannot be drawn from the available numerical results.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of the difference between a detailed study description and a reportable treatment-effect estimate. The registry record identifies a randomized parallel-group comparison, quadruple masking, a placebo comparator, and a continuous primary outcome. Those features define the intended basis for comparing the arms. Yet the primary endpoint’s numerical analysis is not reported, so the design information cannot be translated into an estimate of the treatment contrast.
The study also illustrates why endpoint definitions matter. Average daily low back pain was based on ratings over a specified period and used a scale with clear anchors. This improves interpretability of the intended measure, but does not answer questions about the number of participants contributing data, the handling of missing observations, or the precision of the comparison. Statistical transparency requires those analysis details as well as the measure itself.
Multiple listed outcomes and assessment times make the prespecified analysis strategy important. In general, readers need to know which outcome and contrast were primary, how secondary results were treated, and whether any adjustment was used to address multiple testing. Those details are not reported in the registry record. The absence of a numerical primary result also prevents readers from relating the planning assumptions to an observed effect.
Finally, the safety summary demonstrates the limits of interpreting small descriptive counts without event-level context or a reported comparative analysis. The posted counts are useful as a record of what was summarized, but they are not a substitute for complete efficacy and safety reporting. The statistical importance of this study is therefore as much about what remains unavailable as about the design that was recorded.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The most consequential limitation for interpretation is that numerical results for the primary endpoint are not reported in the registry record. The record does not give arm-level Week 16 changes, standard deviations, a between-group estimate, confidence intervals, or p-values. The primary result’s direction, magnitude, and precision are therefore unknown from the posted results. Numerical analyses for the listed secondary outcomes are also not reported.
The endpoint population is defined as participants evaluable for the endpoint, but the number evaluable is not reported in the registry record. The record does not give participant flow by arm, the number contributing data at each assessment, or reasons for missing endpoint observations. Missing-data methods, analysis-population definitions, and sensitivity analyses are not reported. These omissions prevent assessment of how incomplete follow-up may have affected estimates.
The record describes multiple assessment times and outcomes but does not report the statistical analysis plan, the handling of multiplicity, interim analyses, or the model for repeated measurements. The protocol’s sample-size justification is not reported. The trial status is terminated, but the reason for termination is not reported in the registry record; no explanation should be inferred from status alone.
The safety summary is limited to selected counts and serious-event terms. It does not provide event-level timing, duration, outcome, or treatment attribution. The registry record does not report a statistical comparison of the safety groups. The enrolled population also had both chronic low back pain and hip or knee osteoarthritis, so the stated study question pertains to that specified population; the record does not establish how findings would apply to other populations. Most importantly, without efficacy results, the trial’s comparative primary outcome cannot be interpreted.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Evaluate the Efficacy and Safety of Fasinumab in Patients With Moderate-to-Severe Chronic Low Back Pain and Osteoarthritis of the Hip or Knee — NCT03285646.
- Registry record last updated 2021-06-30; status last verified 2021-06.
- Results first posted 2021-06-30.
- 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 record describes a Phase 3 randomized, double-blind, placebo-controlled, parallel-group study with quadruple masking. It enrolled 63 participants with moderate-to-severe non-radicular chronic low back pain and osteoarthritis of the hip or knee. Fasinumab was described as 3 mg by subcutaneous injection every 4 weeks, with matching placebo administered on the same schedule. The study status is terminated.
The primary endpoint was change from baseline to Week 16 in average daily low back pain intensity on an 11-point numeric rating scale. The registry lists additional patient-reported, arthropathy, adverse-event, and other outcomes. Numerical efficacy analyses for the primary and secondary outcomes are not reported in the registry record. Selected safety counts are reported by arm, including serious and other adverse-event categories and deaths.
The record does not report the termination reason, primary analysis estimate, uncertainty, missing-data approach, or multiplicity plan. The posted information supports a description of the intended comparison and selected safety summaries, but not a quantitative conclusion about comparative efficacy.