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 Different Antiplatelet Therapy Strategy After Coronary Artery Bypass Graft Surgery (NCT02201771), a randomized phase 4 study. The primary outcome is The Patency of Saphenous Vein Grafts.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02201771 |
| Phase | Phase 4 |
| Condition | Coronary Artery Bypass, Antiplatelet Agents |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 500 |
| Arms in the primary outcome | 3 |
| Lead sponsor | Ruijin Hospital |
| Results posted | Yes |
2. Clinical Question
Population
Patients undergoing elective coronary artery bypass graft surgery (CABG). The registry describes a planned total enrollment of 500 and says consent and randomization were to occur before surgery. The primary endpoint population is described as an intention-to-treat analysis, with missing graft data counted as occluded.
Intervention
Ticagrelor 90mg by mouth twice daily, restarted within the first 24 hours after surgery and continued for 12 months.
Comparator
Aspirin 100mg by mouth daily for 12 months, restarted within the first 24 hours after surgery. A third randomized group received ticagrelor 90mg twice daily plus aspirin 100mg daily over the same treatment period.
Primary question
Does ticagrelor alone, or ticagrelor plus aspirin, produce greater 12-month saphenous vein graft patency than aspirin alone? Patency was assessed by multislice computed tomography angiography or coronary angiography. The registry describes superiority as the study aim, but does not report a formal primary comparison or its statistical result.
The trial addresses a comparative question about postoperative antiplatelet strategies and an imaging-based graft outcome. Its three-arm structure permits two treatment-versus-aspirin questions, rather than a single comparison between two groups. The posted primary results give an estimate for each arm, but the registry record does not report a test of either active strategy against aspirin. The arm estimates therefore describe the observed pattern; they do not by themselves establish the result of the planned superiority comparisons.
The study was open-label, and randomization was planned before surgery. The primary endpoint depends on imaging assessment of grafts, with a specified definition of patency: FitzGibbon grade A, meaning stenosis <50%. The registry does not report whether image readers were masked or provide further detail on how graft-level observations were combined into participant-level results. These details matter when interpreting what the percentages represent and how measurement variability may affect the comparison.
3. Trial Design
This was a phase 4, randomized, parallel-group, open-label trial sponsored by Ruijin Hospital. The registry lists 500 participants as the enrollment and describes allocation in a 1:1:1 ratio, with 167 patients per group in the study summary. Participants undergoing elective CABG were to stop oral antiplatelet drugs before surgery according to local protocol. Study treatment was to restart within the first 24 hours after surgery and continue for 12 months.
The three strategies were aspirin 100mg daily, ticagrelor 90mg twice daily plus aspirin 100mg daily, and ticagrelor 90mg twice daily alone. The primary completion date is 2017-01, and the registry status is completed. The posted primary results include 166 participants for aspirin, 168 for ticagrelor plus aspirin, and 166 for ticagrelor. These observed group counts differ from the planned allocation figures in the study summary; the registry record does not explain the difference.
At 12 months, participants were to undergo multislice computed tomography angiography to assess vein graft patency. The primary endpoint is stated as the percentage of patent saphenous vein grafts up to 12 months, with coronary angiography also listed as an assessment method. The registry describes an intention-to-treat population for the primary endpoint and says missing data were treated as occluded grafts.
The record lists five secondary outcome topics, including postoperative atrial fibrillation, freedom from angina, major adverse cardiovascular events, and major bleeding. Numerical results are posted for postoperative atrial fibrillation and freedom from angina. Numerical results for the other listed secondary topics are not reported in the registry record. The registry lists seven outcome measures overall but no reported analyses. Details such as the randomization sequence method, concealment, planned statistical analysis, sample-size justification, and interim analyses are not reported in the registry record.
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 | Aspirin | Ticagrelor Plus Aspirin | Ticagrelor |
|---|---|---|---|
| STARTED | 166 | 168 | 166 |
| COMPLETED | 153 | 158 | 156 |
| NOT COMPLETED | 13 | 10 | 10 |
Reasons for not completing this period:
| Reason | Aspirin | Ticagrelor Plus Aspirin | Ticagrelor |
|---|---|---|---|
| Death | 3 | 2 | 0 |
| Protocol Violation | 10 | 8 | 10 |
Analysis population for the primary outcome, as defined in the registry: ITT analysis, Patients with missing data were considered to have occluded saphenous vein grafts.
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 | Aspirin | Ticagrelor Plus Aspirin | Ticagrelor | Total |
|---|---|---|---|---|---|
| Participants analysed | 166 | 168 | 166 | 500 | |
| Age, Continuous | years | 64.0 (SD 8.1) | 63.5 (SD 8.2) | 63.3 (SD 8.3) | 63.6 (SD 8.2) |
| Sex: Female, Male: Female | Participants | 25 | 34 | 32 | 91 |
| Sex: Female, Male: Male | Participants | 141 | 134 | 134 | 409 |
| Region of Enrollment: China | participants | 166 | 168 | 166 | 500 |
6. Primary Endpoint
The registry lists the primary outcome as The Patency of Saphenous Vein Grafts, measured over up to 12 months.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | percentage of patent SV grafts |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is saphenous vein graft patency, expressed as the percentage of patent grafts through 12 months. The registry defines a graft as patent when it has FitzGibbon grade A, corresponding to stenosis <50%. Assessment was to use multislice computed tomography angiography or coronary angiography.
Patency is used as an anatomical measure of whether a graft remains open. In this trial, it provides an imaging-based outcome for comparing postoperative antiplatelet strategies. It is distinct from a patient-reported symptom, a clinical event, or a measure of survival; the endpoint reports graft status rather than directly summarizing all aspects of a participant’s health. The other listed outcomes include clinical events and symptoms, but those are separate outcomes and should not be conflated with graft patency.
The posted primary estimates are 76.5% for aspirin, with a 95% confidence interval of 70.8% to 82.1%; 88.7% for ticagrelor plus aspirin, with a 95% confidence interval of 84.6% to 92.8%; and 82.8% for ticagrelor, with a 95% confidence interval of 78.0% to 87.6%. These are arm-specific estimates. The registry record does not report a primary treatment contrast, confidence interval for a contrast, or p-value for either comparison with aspirin.
The analysis description says the primary population was intention-to-treat and that missing data were considered to represent occluded grafts. This is a specified handling rule, not evidence that every participant had imaging available. The number of participants with missing imaging or the number of grafts assessed is not reported in the registry record. Those omissions limit evaluation of how much the primary estimates depend on the missing-data rule and how precisely the graft-level information was summarized.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The primary estimates show a descriptive ordering across the three arms: the highest reported patency percentage is for ticagrelor plus aspirin, followed by ticagrelor alone and then aspirin. Each estimate is accompanied by a 95% confidence interval, giving a range of values compatible with the data under the interval’s statistical assumptions. The intervals describe uncertainty around individual arm estimates; they are not confidence intervals for differences between treatments.
The registry record does not post a formal comparison for the primary endpoint. It therefore does not establish, from the posted results alone, whether either ticagrelor strategy met the stated superiority objective. A comparison requires a direct estimate of the difference between arms, its uncertainty, and the analysis method. Comparing the arm percentages informally is not a substitute for that inferential result. The registry also does not report a primary p-value or an adjusted analysis for graft patency.
The intervals for the three arm estimates overlap. That observation is not itself a formal test of treatment differences. Confidence intervals for separate groups and a confidence interval for a contrast answer different questions, and the latter cannot be recovered by simply inspecting whether the former overlap. No new contrast should be inferred from the arm estimates without an explicitly specified calculation and its assumptions.
The two secondary outcomes with posted numerical results have recalculated, unadjusted comparisons. For postoperative atrial fibrillation, the recalculated risk-difference intervals for both active strategies include no difference. For freedom from angina, the recalculated intervals likewise include no difference. These are unadjusted analyses based on posted summary counts, not analyses reported by the sponsor. They should be read as exploratory descriptions rather than confirmatory evidence, especially because several outcome topics and comparisons are involved and the registry does not report a multiplicity plan.
The secondary findings do not overturn or confirm the primary result. They address different outcomes, have their own uncertainty, and cannot compensate for the absence of a reported primary contrast. Likewise, the safety counts are descriptive and do not establish comparative safety. The numbers of serious events and deaths are small counts in the posted groups, and the registry does not provide adjusted comparisons or a detailed account of how events were adjudicated.
The essential distinction is between an observed arm estimate and a comparative conclusion. The posted results describe graft patency percentages and selected secondary counts. They do not give the formal primary hypothesis test, its estimate of treatment contrast, or the full statistical analysis plan. The registry’s stated goal of testing superiority should therefore be distinguished from the evidence available in its posted numerical results.
9. Statistical Methods Explained
Statistical interpretation depends on separating estimates, uncertainty intervals, and tests of treatment contrasts. The registry posts primary patency estimates for each randomized group with 95% confidence intervals. These intervals communicate the statistical uncertainty around each group’s estimate. They do not directly answer whether two groups differ, because a treatment contrast has its own estimate and uncertainty. The registry record does not report a primary contrast or a primary test, so the arm-specific intervals should not be treated as a substitute.
What does an interval express?
As a general statistical explanation, a confidence interval is constructed by a method intended to capture the target quantity at its stated long-run frequency when the assumptions hold. A narrower interval indicates greater precision than a wider interval for the same type of estimate, but interval width alone does not establish clinical importance. For this trial, the confidence intervals attach to each arm’s patency estimate. They do not provide the uncertainty around the difference between ticagrelor plus aspirin and aspirin, or between ticagrelor and aspirin.
The primary endpoint is a percentage of patent saphenous vein grafts. The registry specifies an intention-to-treat population and defines missing primary data as occluded grafts. That rule assigns an outcome status for analysis when data are missing; it does not recover the unknown graft status. It may influence the estimate, depending on how many data are missing and how those cases are distributed. The count of missing data is not reported in the registry record, so the extent of that influence cannot be assessed from the posted information.
What do the recalculated secondary comparisons mean?
The risk differences for the two secondary outcomes with numerical results are recalculated from posted group counts. A risk difference expresses the difference between the proportions with an outcome in two groups. These recalculated values are simple, unadjusted comparisons and are not sponsor-reported analyses. The confidence intervals for those comparisons include zero, the value corresponding to no risk difference. The associated unadjusted p-values are 0.595 and 0.078 for postoperative atrial fibrillation, and 0.638 and 0.829 for freedom from angina, in the order of the combination strategy and ticagrelor alone. These quantities should not be read as definitive evidence for or against a treatment effect.
As a general statistical explanation, a p-value describes how incompatible data are with a specified null model under the assumptions of the test. It is not the probability that the null hypothesis is true, and it does not measure the size or importance of an effect. An unadjusted p-value also does not account for the fact that several outcomes or comparisons may have been examined. The registry record does not report the sponsor’s analyses for these secondary outcomes, nor does it report a multiplicity strategy.
The recalculated secondary confidence intervals and p-values are not adjusted for covariates, multiplicity, or any analysis features not available from the posted summary counts. They may not match a planned analysis if that analysis used a different method or population. The registry record lists no reported analyses, so there is no posted sponsor analysis against which to assess these calculations. The sponsor’s own analysis would take precedence if it were available; the registry record does not include one for these comparisons.
Why can over-dispersion matter?
As a general statistical explanation, over-dispersion occurs when outcome variability exceeds what a model assumes. If a model underestimates variability, its standard errors can be too small and its intervals too narrow, making evidence appear more precise than it is. The posted primary endpoint is a graft percentage, and grafts may be clustered within participants; however, the registry record does not explain the unit of statistical analysis, how multiple grafts per participant were handled, or whether clustering was accounted for. It is therefore not possible to determine from the record whether over-dispersion or within-participant dependence was relevant to the sponsor’s method.
The primary outcome description also does not specify whether the percentages were calculated from grafts, participants, or another aggregation. The unit is described as percentage of patent saphenous vein grafts, while the analysis population is described in terms of patients. Without further detail, the exact construction of the estimate and its confidence interval cannot be independently evaluated. This is a reporting limitation rather than proof that the analysis was inappropriate.
How should planning illustrations be read?
The sample-size illustrations are planning calculations based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. They give participants per arm for 80% and 90% power under specified fractions of the observed effect. For example, planning for 100% of the observed ticagrelor-versus-aspirin effect for postoperative atrial fibrillation gives 418 participants per arm for 80% power and 558 participants per arm for 90% power. Planning for 75% of that observed effect gives 788 participants per arm for 80% power and 1,054 participants per arm for 90% power.
These are planning illustrations, not the trial’s original sample-size justification and not observed power. The registry record does not report the assumptions used to design the trial. Because the estimates use observed effects, they are also sensitive to the particular results in this trial; they should not be treated as an independent confirmation of those results. The assumptions do not establish that a future study would have the same event rates, effect, or analysis conditions.
In general, power is a design property calculated under specified assumptions about an effect, variability, allocation, and testing procedure. It is not a retrospective measure of whether a result is true. The planning examples help illustrate how sample-size requirements can change when the target effect differs from the observed effect, but they do not replace a prespecified design calculation. The record does not report whether interim analyses, covariate adjustment, or other design features were planned.
10. Multiplicity, Missing Data and Analysis Populations
The registry record describes the primary endpoint as an intention-to-treat analysis and states that missing data were considered to represent occluded saphenous vein grafts. This is the only specific missing-data rule reported for the primary outcome. The number of participants or grafts with missing imaging, reasons for missingness, and any sensitivity analyses are not reported in the registry record. Consequently, readers cannot assess how often the rule was applied or how alternative assumptions might affect the estimate.
The record names two active-versus-aspirin superiority questions for the primary endpoint. It does not report how those two comparisons were handled statistically, whether one was designated as the key comparison, or whether multiplicity was controlled. It also does not report a primary contrast estimate, a confidence interval for either contrast, or a primary p-value. The stated study aim is not the same as a posted analysis result.
For secondary outcomes, the registry names several outcome topics and the recalculated results include more than one comparison for the outcomes with counts. A multiplicity strategy—such as a prespecified hierarchy or adjustment—is not reported in the registry record. The unadjusted secondary results should therefore be interpreted cautiously, especially as exploratory results rather than as a collection of independent confirmatory tests.
The primary population is identified as intention-to-treat, but the registry does not report details about participant exclusions, adherence, crossover, or analysis populations for the secondary endpoints. It does not provide a participant flow account or explain the difference between the planned group allocation and the posted primary group counts. Missing-data methods for the secondary outcomes are not reported in the registry record. Details about randomization procedures, covariate adjustment, interim analyses, and the full statistical plan are also not reported in the registry record. These gaps prevent a full assessment of analysis choices and their potential effect on the reported findings.
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 |
|---|---|---|---|
| Aspirin | 9 | 166 | 5.4% |
| Ticagrelor Plus Aspirin | 3 | 168 | 1.8% |
| Ticagrelor | 3 | 166 | 1.8% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Aspirin | 3 of 166 |
| Ticagrelor Plus Aspirin | 2 of 168 |
| Ticagrelor | 0 of 166 |
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 |
|---|---|
| Aspirin | 78 of 166 |
| Ticagrelor Plus Aspirin | 91 of 168 |
| Ticagrelor | 74 of 166 |
Most frequent serious adverse event terms
| Event term | Organ system | Aspirin | Ticagrelor Plus Aspirin | Ticagrelor |
|---|---|---|---|---|
| Nonfatal myocardial infarction | Cardiac disorders | 3 of 166 | 2 of 168 | 2 of 166 |
| Nonfatal stroke | Cardiac disorders | 4 of 166 | 0 of 168 | 2 of 166 |
| Cardiovascular death | Cardiac disorders | 2 of 166 | 1 of 168 | 0 of 166 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Aspirin | Ticagrelor Plus Aspirin | Ticagrelor |
|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | 25 of 166 | 22 of 168 | 15 of 166 |
| Hypoproteinemia | Metabolism and nutrition disorders | 17 of 166 | 22 of 168 | 18 of 166 |
| Perioperative myocardial injury | Cardiac disorders | 11 of 166 | 25 of 168 | 14 of 166 |
| Anaemia | Blood and lymphatic system disorders | 14 of 166 | 10 of 168 | 12 of 166 |
| Renal disfunction | Renal and urinary disorders | 6 of 166 | 12 of 168 | 9 of 166 |
| Incision complication | Injury, poisoning and procedural complications | 10 of 166 | 9 of 168 | 6 of 166 |
Serious events with the highest arm-level rate: nonfatal stroke (2.4%), nonfatal myocardial infarction (1.8%), cardiovascular death (1.2%).
The registry posts serious adverse event counts of 9 among 166 participants in the aspirin group, 3 among 168 in the ticagrelor-plus-aspirin group, and 3 among 166 in the ticagrelor group. It also posts deaths of 3, 2, and 0 in those groups, respectively. These are descriptive counts, not adjusted comparisons, and the record does not provide confidence intervals or formal statistical tests for them.
The listed serious-event terms include nonfatal stroke at 2.4%, nonfatal myocardial infarction at 1.8%, and cardiovascular death at 1.2%. The registry does not assign these term percentages to individual treatment arms in the posted information. They should not be used to infer an arm-specific event rate.
Event counts can be informative, but they do not by themselves establish whether the strategies differ in safety. Interpretation depends on event definitions, follow-up, completeness of reporting, and the comparative analysis. The registry record does not report further detail about adjudication, severity criteria, or a statistical safety analysis. The figures therefore describe what was posted; they do not support a definitive comparative conclusion.
12. What the Result Does, and Does Not, Mean
The posted primary results show that the estimated percentage of patent saphenous vein grafts was highest in the ticagrelor-plus-aspirin group, followed by ticagrelor alone and aspirin. The estimates are accompanied by 95% confidence intervals, so they convey both a point estimate and uncertainty. They do not, on their own, establish that one treatment strategy is superior to aspirin. The registry record does not provide the formal primary comparisons needed to evaluate the stated superiority objective.
The primary endpoint is a specific imaging-based measure and should not be read as a summary of every patient outcome. The trial also listed symptoms and clinical events as secondary outcomes, but numerical results are posted for only some of them. The posted secondary calculations are unadjusted and have uncertainty intervals that include no difference. They do not demonstrate equivalence, nor do they resolve the primary comparison.
The findings also do not establish the full safety profile of the strategies. The record includes group counts for serious adverse events and deaths, but does not report formal comparative safety analyses or detailed event methods. Absence of a reported difference is not evidence that risks are identical, just as a numerical difference in counts is not by itself proof of a treatment effect.
More broadly, the results apply to the trial’s reported population and outcome definitions. The registry describes elective CABG, treatment for 12 months, and graft assessment up to 12 months. Information about site number, participant characteristics, imaging completeness, and generalizability is not reported in the registry record. The results should therefore be interpreted within the boundaries of the population, procedures, and information actually documented.
The most defensible conclusion is descriptive: three arm-specific patency estimates are posted, and selected secondary and safety counts are available. A complete inferential conclusion about the trial’s primary objective would require the prespecified comparison method and sponsor-reported primary contrast, neither of which is reported in the registry record. The numerical pattern can motivate further examination, but it cannot substitute for those missing analyses.
13. Why This Trial Matters Statistically
This trial illustrates why reporting arm-level estimates is not enough for a randomized comparison. Randomization is intended to support a causal comparison between strategies, but the statistical result needed for that comparison is a contrast between groups, together with its uncertainty and method. The registry posts primary estimates separately for each arm but does not report the primary contrast. This leaves the stated superiority objective without a posted inferential result.
The trial also highlights the importance of defining the analysis population and missing-data approach. The primary endpoint uses an intention-to-treat description and treats missing graft data as occluded. That rule is explicit, but the record does not report the amount of missing data or sensitivity analyses. A transparent rule is useful; evaluation of its impact also requires information about how often it applies and whether conclusions change under reasonable alternatives.
Its three-arm structure brings multiplicity into view. There are two active-treatment comparisons against aspirin, along with several secondary outcomes. Without a reported plan for prioritizing or adjusting these tests, unadjusted secondary analyses should be read as exploratory. The trial therefore demonstrates why statistical reporting should connect the design, endpoint, analysis population, comparisons, and interpretation rather than presenting isolated estimates.
Finally, the endpoint is a percentage of patent grafts, while participants are randomized. The registry record does not explain how the graft-level information was summarized or whether dependence among multiple grafts within a participant was considered. This makes the unit of analysis an important reporting detail. Clear description would help readers judge whether uncertainty estimates reflect the structure of the data.
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.
Several limitations arise from the registry reporting. The primary arm estimates are available, but the formal comparisons that correspond to the study’s superiority aim are not. Without contrast estimates, confidence intervals for contrasts, or primary p-values, the main inferential question cannot be answered from the posted results alone. The registry lists no reported analyses.
The primary outcome is defined using graft imaging, but the record does not report the number of grafts assessed, missing imaging counts, reasons for missingness, or the way graft observations were summarized for each participant. It states that missing data were treated as occluded, but offers no sensitivity analysis. The group counts are participant counts, and the record does not explain how they relate to the number of grafts contributing to the percentages.
The registry describes an open-label trial. It does not report whether those assessing or interpreting imaging were masked, or provide further details about assessment procedures. The treatment period is stated as 12 months, and primary assessment is described as up to 12 months; longer-term outcomes are not reported in the registry record. These features limit what can be inferred about blinding and duration of follow-up.
Only some of the listed secondary outcomes have numerical results. Sponsor-reported analyses for the posted secondary outcomes and a multiplicity plan are not reported in the registry record. The recalculated secondary comparisons are unadjusted and based on summary counts, so they do not replace a prespecified analysis. The record also does not report detailed participant characteristics, recruitment sites, adherence, crossover, or a complete participant flow. These omissions constrain assessments of applicability, analysis conduct, and possible sources of bias.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Different Antiplatelet Therapy Strategy After Coronary Artery Bypass Graft Surgery — NCT02201771.
- Registry record last updated 2019-08-13; status last verified 2019-08.
- Results first posted 2019-07-01.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT02201771 is a completed, phase 4, randomized, open-label, parallel-group trial sponsored by Ruijin Hospital. It enrolled 500 participants according to the registry entry and compared aspirin, ticagrelor plus aspirin, and ticagrelor alone after elective CABG. Treatment was planned for 12 months, with primary assessment of saphenous vein graft patency by imaging.
The primary outcome is reported as an arm-specific percentage with a 95% confidence interval. The registry record does not report formal primary comparisons or a statistical analysis. Numerical results are posted for two secondary outcomes, while other named secondary outcomes do not have numerical results in the registry record. The primary missing-data rule is stated, but the amount of missing data and sensitivity analyses are not reported.
Interpretation should distinguish the observed arm estimates from comparative evidence. The posted values describe the study results, but the missing primary contrast, multiplicity details, and additional analysis information limit conclusions about superiority and the broader outcome pattern.