A Randomized Controlled Trial of TNK-tPA Versus Standard of Care for Minor Ischemic Stroke With Proven Occlusion: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Randomized Controlled Trial of TNK-tPA Versus Standard of Care for Minor Ischemic Stroke With Proven Occlusion (NCT02398656), a randomized phase 3 study. The primary outcome is Number of Participants With Return to Baseline Neurological Functioning Measured by the Modified Rankin Scale (mRS).

2. Clinical Question

This is a comparison of treatment strategies in a specified acute stroke setting, not a comparison of tenecteplase with a single fixed antiplatelet regimen. The standard-care group could receive different antiplatelet choices at the treating clinician’s discretion. That flexibility is part of the clinical question represented by the registry record.

3. Trial Design

The registry identifies NCT02398656 as a phase 3, randomized, parallel-group trial. Its title describes a comparison of TNK-tPA with standard care for minor ischemic stroke with proven occlusion. The official title characterizes the trial as multicentre, prospective, open label, and blinded endpoint, using a PROBE design. The registry’s masking field is listed as single. These descriptions indicate that treatment assignment was not fully concealed from everyone involved, while the primary outcome assessment was intended to be blinded to treatment assignment.

The intervention group received tenecteplase as a single intravenous bolus immediately upon randomization. The control group received antiplatelet-based standard care, with treatment choice left to the treating physician or investigator. The registry describes symptom onset within 12 hours as part of the intended clinical setting. It lists an enrollment of 1274 and a completed status. The recorded start date is 2015-04-01, and the primary completion date is 2024-01-19.

The sponsor is the University of Calgary. The registry identifies a coordinating centre in Calgary, Alberta, Canada, and says approximately 50 sites were expected to participate worldwide. The brief summary names Dr. Shelagh Coutts as principal investigator. The outcome was assessed at 90 days, in person where possible and by telephone otherwise, using a structured modified Rankin Scale questionnaire. The registry does not report the original allocation ratio or further operational details about allocation concealment.

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

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.

6. Primary Endpoint

The registry lists the primary outcome as Number of Participants With Return to Baseline Neurological Functioning Measured by the Modified Rankin Scale (mRS), measured over 90 Days.

The primary endpoint is the number of participants meeting a definition of return to baseline neurological functioning on the modified Rankin Scale at 90 days. This is a responder outcome: each participant is classified according to whether the 90-day score meets the favorable-outcome rule based on the pre-morbid score. For a pre-morbid score of 0-1, a score of 0-1 at 90 days counts as favorable; for a pre-morbid score of 2, a score of 0-2 counts as favorable.

The modified Rankin Scale is an ordinal measure of disability, ranging from 0-6, with higher scores indicating a worse outcome. The registry says the pre-morbid score was assessed before randomization and the 90-day assessment was completed by an individual blinded to treatment assignment. A structured questionnaire was used for in-person and telephone assessments. The outcome therefore reflects a thresholded assessment of disability relative to baseline, rather than the full distribution of scale scores.

A responder endpoint can make the clinical target straightforward to interpret: it counts participants who meet a prespecified definition of favorable functioning. It also discards some detail, because people on either side of the threshold are grouped into outcome categories. The registry record does not report the rationale for selecting this particular responder definition.

7. Results Posted in the Registry

• Tenecteplase (tNK): 71.5% (309/432) versus 74.8% (338/452) on control; risk difference -3.3 percentage points (95% CI -9.1 to 2.6), risk ratio 0.96 (0.88–1.04); unadjusted two-proportion z-test p = 0.275.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Number of Participants With Modified Rankin Score (mRS) 0-1 at 90 Days

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Tenecteplase (tNK): 69.0% (298/432) versus 71.0% (321/452) on control; risk difference -2.0 percentage points (95% CI -8.1 to 4.0), risk ratio 0.97 (0.89–1.06); unadjusted two-proportion z-test p = 0.509.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Tenecteplase (tNK) and the control. The interval gives the range of effects that remain compatible with the data.

The registry lists one secondary outcome: the number of participants with mRS 0-1 at 90 days. The posted counts are 298 of 432 in the tenecteplase group and 321 of 452 in the control group. Its unadjusted recalculated risk difference is -0.020, with a 95% confidence interval from -0.081 to 0.040 and an unadjusted p-value of 0.509. As with the primary endpoint, the estimate is negative and the interval includes no difference. This is a broad similarity in the direction and uncertainty of the two endpoint comparisons, not a separate demonstration of a treatment effect.

The secondary endpoint is closely related to the primary endpoint because both use the modified Rankin Scale at 90 days. However, the endpoint definitions are not the same: the primary responder rule incorporates the participant’s pre-morbid score, whereas the secondary endpoint uses mRS 0-1. The secondary result can therefore add context about a related threshold, but it does not replace or independently verify the primary analysis.

Unadjusted secondary findings generally carry less weight than a prespecified primary analysis when several outcomes or analyses are considered. Looking at multiple results increases the chance that some may appear noteworthy by chance, and the registry record does not report a multiplicity procedure. The record also does not provide a sponsor-reported analysis for the secondary endpoint. The secondary result should therefore be read as supportive descriptive evidence, with the uncertainty and analysis limitations kept in view, rather than as a stand-alone confirmatory conclusion.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Number of Participants With Modified Rankin Score (mRS) 0-1 at 90 Days

9. Statistical Interpretation

10. Statistical Methods Explained

The primary endpoint is binary for analysis: participants either meet the registry’s favorable-outcome definition at 90 days or they do not. The registry reports outcome counts and group sizes, and the posted comparison is expressed as a risk ratio. A simple recalculation also expresses the comparison as a risk difference. These are two ways of describing the contrast in event occurrence; they use different scales and should not be read as interchangeable numeric quantities.

What does a risk ratio describe?

A risk ratio compares the probability of meeting the outcome in one group with the probability in the other. A value near the no-effect value indicates similar observed probabilities on the ratio scale; a value below it indicates a lower observed probability in the numerator group, while a value above it indicates a higher one. The sponsor reported a risk ratio of 0.96, with a 95% confidence interval from 0.88 to 1.04. Because this interval includes the no-effect value, the estimate is compatible with no clear difference as well as with effects in either direction. The sponsor’s posted analysis does not report a p-value.

What does a risk difference describe?

A risk difference subtracts one group’s event probability from the other group’s event probability. The unadjusted recalculation gives -0.033, with a 95% confidence interval from -0.091 to 0.026. The negative point estimate indicates a lower observed favorable-outcome proportion in the tenecteplase group, while the interval includes zero and extends to positive values. That span conveys uncertainty about both the direction and the size of the difference. The accompanying unadjusted p-value is 0.275. This p-value is a measure of how compatible the observed data are with a no-difference model under the calculation’s assumptions; it is not the probability that the treatment has no effect.

The recalculation is based on posted summary counts and is unadjusted. It does not incorporate covariate adjustment, stratification, or any other trial-specific modelling unless those features are represented in the posted summaries. The registry record does not report the sponsor’s statistical method for the primary analysis. The recalculated quantities therefore provide a transparent summary-statistic comparison, not a reconstruction of an unreported analysis plan.

Why do confidence intervals matter?

A confidence interval expresses the precision of an estimate under the method used to calculate it. A relatively broad interval permits a wider range of underlying effects than a narrow one. The primary risk-difference interval crosses zero, and the sponsor’s risk-ratio interval includes its no-effect value. Neither interval rules out effects in both directions. The point estimate alone should not be treated as the complete result: it is only the centre of an uncertain range.

Why distinguish the endpoint from the scale?

The modified Rankin Scale itself is ordinal, with scores from 0-6 and higher scores indicating worse outcomes. The primary analysis does not compare every possible score separately; it classifies participants using the responder definition based on pre-morbid and 90-day scores. A binary analysis makes the stated threshold easy to interpret, but it does not retain the full pattern of disability scores. Two participants classified on the same side of the threshold may have different scale scores, and a change in score that does not cross the threshold will not change the responder classification.

The secondary outcome uses the threshold of mRS 0-1 at 90 days. It is related to, but not identical to, the primary endpoint, because the primary rule also accounts for a pre-morbid score of 2. The registry reports a separate unadjusted comparison for this secondary outcome but no sponsor-reported analysis. Interpretation should account for the relationship between endpoints and the possibility of multiple analyses, rather than treating each result as a separate definitive test.

What does an unadjusted analysis leave out?

An unadjusted calculation compares the posted group summaries without controlling for other variables. Randomization is intended to support a fair comparison between groups, but the registry record does not state whether the sponsor’s analysis used adjustment or how it handled other design features. The unadjusted recalculation is consequently useful for describing the available summary data, but it cannot answer questions about the sponsor’s model or confirm its assumptions. The registry record does not report details of covariate adjustment, missing-data methods, analysis populations, or multiplicity control.

11. Confidence Intervals and Precision

The primary endpoint’s observed counts are 309 of 432 in the tenecteplase group and 338 of 452 in the control group. The sponsor’s risk ratio is 0.96, with a 95% confidence interval from 0.88 to 1.04. On the ratio scale, the interval spans the no-effect value and allows for a range of possible underlying comparisons. It does not support a precise claim that the groups differ in one direction.

The unadjusted risk-difference estimate is -0.033, and its 95% confidence interval runs from -0.091 to 0.026. This range extends from a negative difference through zero to a positive difference. In practical statistical terms, the point estimate is not precise enough to settle the direction of the comparison. A confidence interval is not a guarantee that the true effect lies within its limits; it describes uncertainty under the method and assumptions used to form it.

The secondary endpoint’s recalculated risk difference is -0.020, with a 95% confidence interval from -0.081 to 0.040. This interval also includes zero and permits differences in either direction. Its width reflects uncertainty in the secondary comparison as well; it should not be interpreted as evidence that the groups are equivalent.

Precision is distinct from whether a result crosses a conventional significance threshold. A point estimate can be close to no difference but still have an interval wide enough to leave meaningful uncertainty, while a narrow interval may permit more confident statements about the range of effects. The sponsor’s primary interval and the recalculated primary interval both communicate uncertainty, but they are reported on different scales. The registry record does not give the original target precision or the assumptions used to plan the trial’s enrollment.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning figures are illustrations based on the observed effect, not the trial’s original design assumptions. For these binary outcomes, the figures are participants per arm, not total events. The listed assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is set to the stated fraction of the observed effect. The trial’s own original sample-size assumptions are not reported in the registry record.

The 80% power column gives the illustrative number of participants per arm under those assumptions for a design with an 80% chance of detecting the specified effect if that effect were the true one. The 90% power column gives the corresponding figure for a design with a 90% chance under the same conditions. These are planning concepts, not guarantees about the result of a future study.

For the primary endpoint, planning for 100% of the observed effect gives 2,916 participants per arm for 80% power and 3,903 for 90% power. Planning for 75% of the observed effect gives 5,135 participants per arm for 80% power and 6,874 for 90% power. Planning for 50% of the observed effect gives 11,440 participants per arm for 80% power and 15,314 for 90% power. The secondary endpoint’s corresponding figures are 7,950 and 10,642 for 100% of the observed effect; 14,065 and 18,829 for 75%; and 31,490 and 42,156 for 50%.

Smaller effects are harder to distinguish from random variation, so planning to detect a smaller fraction of the observed effect requires more participants per arm. These values are not observed power: they are hypothetical planning illustrations, and the observed trial results do not establish the true effect size.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, p₀ and p₁ are the control and treatment proportions, and p̄ is their average.

Worked calculation for this trial

1. Control proportion p₀ = 0.748; treatment proportion p₁ = 0.715; average p̄ = 0.732.
2. First term: z_1−α/2 × √[2p̄(1−p̄)] = 1.96 × 0.6267 = 1.2284.
3. Second term: z_1−β × √[p₀(1−p₀) + p₁(1−p₁)] = 0.842 × 0.6263 = 0.5271.
4. n = (1.2284 + 0.5271)² / (-0.0325)² = 2,915.8, rounded up to 2,916 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
p0 <- 0.747787610619469                          # control proportion
p1 <- 0.715277777777778                          # treatment proportion
n_per_arm <- function(power, frac = 1) {
  q1 <- p0 + (p1 - p0) * frac               # smaller effect = fraction of the observed difference
  pbar <- (p0 + q1) / 2
  z_b <- qnorm(power)
  ceiling(round((z_a * sqrt(2 * pbar * (1 - pbar)) + z_b * sqrt(p0 * (1 - p0) + q1 * (1 - q1)))^2 / (q1 - p0)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (unrounded n per arm)
cat("power.prop.test:", round(power.prop.test(p1 = p0, p2 = p1, power = 0.80)$n, 1), "\n")

# Simulation: how often does the z-test reject at the 80%-power sample size?
set.seed(2398656)
n    <- n_per_arm(0.80)
reps <- 20000
x0 <- rbinom(reps, n, p0); x1 <- rbinom(reps, n, p1)
ph <- (x0 + x1) / (2 * n)
z  <- ((x1 - x0) / n) / sqrt(ph * (1 - ph) * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(z) > z_a, na.rm = TRUE), reps))

Output from running the code

100% of observed effect: n per arm = 2,916 (80% power), 3,903 (90% power)
 75% of observed effect: n per arm = 5,135 (80% power), 6,874 (90% power)
 50% of observed effect: n per arm = 11,440 (80% power), 15,314 (90% power)
power.prop.test: 2915.8 
Simulated power at n = 2,916 per arm: 0.805 (20000 replicates)

The simulation draws many pairs of event counts at the planned sample size and counts how often the two-proportion z-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Analyses Reported by the Sponsor

The sponsor-reported primary analysis is a risk ratio of 0.96, with a 95% confidence interval from 0.88 to 1.04. The registry does not include a sponsor-reported p-value for this analysis. The risk ratio interval includes its no-effect value and supports an interpretation of substantial uncertainty about the direction and size of the comparison.

The simple recalculation from the posted group counts uses the risk-difference scale. It gives -0.033, with a 95% confidence interval from -0.091 to 0.026 and an unadjusted p-value of 0.275. The posted summary counts also produce a recalculated risk ratio of 0.957, with a 95% confidence interval from 0.883 to 1.036. Those recalculated ratio values are consistent with the sponsor’s reported risk ratio and interval at the precision shown in the sponsor analysis. The two presentations differ in scale and rounding, not in the broad pattern they convey.

The registry record does not report the method used for the sponsor’s analysis, so the recalculation should not be treated as a replication of that method. It is an unadjusted calculation from summary statistics. The sponsor’s own analysis is the relevant reported trial analysis; the recalculation is a supplementary way to describe the posted counts and their uncertainty.

15. Multiplicity, Missing Data and Analysis Populations

The registry record identifies a primary outcome and one secondary outcome, but it does not report a multiplicity adjustment or a testing hierarchy for interpreting several outcomes together. When researchers examine more than one endpoint, subgroup, or analysis, the chance of finding an apparently notable result by chance can increase. Statistical procedures can address that issue, but the registry record does not say whether such procedures were planned or used. The secondary finding should therefore be interpreted with appropriate caution and in relation to the primary endpoint.

The registry record does not report how missing 90-day outcome assessments were handled. It does not state whether analyses used imputation, complete-case methods, sensitivity analyses, or another approach. The outcome counts and group sizes describe the posted summaries, but they do not establish why the counts used for the endpoint differ from the enrollment figure. No inference about the missing participants or their outcomes can be made from the record alone.

The analysis population is also not reported in the registry record. It is not stated whether the primary analysis followed an intention-to-treat principle, included only participants who received assigned treatment, or used another defined population. The record does not give details of protocol deviations or how they were addressed. Those details matter because the analysis population and missing-data approach can affect the estimate and the interpretation of uncertainty.

The registry describes an open-label, blinded-endpoint design and identifies a blinded assessor for the 90-day outcome. It does not report further information about assessor procedures, adjudication, or any sensitivity checks related to outcome assessment. These unreported features limit the ability to reconstruct the full analysis plan from the registry entry.

16. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 1% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: symptomatic intracerebral hemorrhage (3.7%).

The registry reports serious adverse events in 16 participants at risk of 432 in the tenecteplase group and 2 participants at risk of 452 in the control group. For other adverse events, the corresponding posted counts are 35 at risk of 435 in the tenecteplase group and 33 at risk of 452 in the control group. Death counts are 20 in the tenecteplase group and 5 in the control group. The registry identifies symptomatic intracerebral hemorrhage as the top serious adverse-event term and reports 3.7% for that term.

These are descriptive safety counts, not adjusted comparisons. The record does not provide a statistical comparison for these outcomes, event timing, severity details beyond the serious-event classification, or a basis for attributing events to treatment. The denominators differ for the tenecteplase group’s serious and other adverse-event summaries, so each count should be read with its posted at-risk denominator. The 3.7% figure is reported for the serious adverse-event term; the registry does not give an arm-specific figure for that term. These data describe reported events in the record and do not by themselves establish a causal safety difference.

17. What the Result Does, and Does Not, Mean

The primary result is an uncertain comparison of the proportion meeting a 90-day return-to-baseline definition. The sponsor-reported risk ratio and the unadjusted recalculation both have confidence intervals that include their respective no-effect values. The results therefore do not establish a clear difference between the randomized groups on the primary endpoint. They also do not establish equivalence: the intervals allow for effects in either direction, and no equivalence margin is reported in the registry record.

The outcome is specific to a responder definition based on the pre-morbid and 90-day modified Rankin Scale. It is not a complete description of every participant’s disability trajectory, and it does not report the full distribution of mRS scores. The secondary outcome uses a related but different threshold. The interpretation also applies to the trial’s comparison of tenecteplase with physician-selected antiplatelet-based standard care, rather than to a single uniform control treatment.

The record describes a trial in minor ischemic stroke with proven occlusion and a treatment window within 12 hours of symptom onset. These results should not be generalized from the registry record alone to other populations, settings, or treatment choices. The trial’s posted outcomes also do not determine how individual patients should be treated. They describe group-level data and their statistical uncertainty, not an individualized prediction.

Finally, details that would help assess the complete evidentiary picture are not reported in the registry record, including the sponsor’s statistical method, missing-data handling, analysis population, and multiplicity approach. Those absences do not change the posted counts or intervals, but they limit how fully the analysis can be evaluated. The most defensible reading is therefore descriptive and bounded: the posted primary comparison is imprecise, and it does not by itself settle whether the groups differ.

18. Why This Trial Matters Statistically

This trial poses a useful statistical question because it evaluates a defined functional outcome in an acute stroke setting and compares an intervention with a form of standard care that allowed clinician choice. The primary endpoint uses a responder rule tied to pre-morbid functioning, making the target outcome clinically interpretable while also creating a threshold-based analysis. That distinction matters: a binary responder result is not the same as a comparison of the full ordinal scale.

The reported risk ratio and the recalculated risk difference illustrate why both an effect estimate and its uncertainty are needed. The point estimate gives a direction and scale, while the confidence interval communicates how much uncertainty remains. Here, the primary interval on each scale includes its no-effect value. Reporting only the point estimate, or only the outcome counts, would give an incomplete statistical account.

The trial also illustrates the importance of separating an observed result from planning calculations. The sample-size illustrations use the observed effect as a planning input and show how assumptions about the effect to detect influence participant requirements. They are not evidence that the trial was designed around those calculations, nor are they a measure of the power observed after the trial.

Finally, the registry’s reporting gaps matter for interpretation. Information about missing data, the analysis population, multiplicity, and the sponsor’s statistical method would help readers assess how the posted summaries were produced and how robust the conclusions are. Clear reporting of these elements supports reproducibility and helps distinguish a result that is uncertain from one that has been established as equivalent or different.

19. 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 are specific to what the registry record reports. It does not give the sponsor’s statistical method for the primary endpoint, the original sample-size assumptions, or the rationale for the responder definition. The record also does not report the analysis population, handling of missing 90-day assessments, or treatment of protocol deviations. These omissions make it difficult to determine how the posted endpoint counts relate to all randomized participants and how closely the simple recalculation matches the sponsor’s analysis method.

The comparison group was not a single fixed antiplatelet regimen. Treatment choice was left to the treating physician or investigator, with the registry describing low-dose aspirin as the choice of most physicians and aspirin plus clopidogrel as another option. This means the comparison represents tenecteplase versus a clinician-selected standard-care strategy, not tenecteplase versus one standardized drug regimen.

The primary outcome converts an ordinal disability scale into a binary responder classification. That supports interpretation of the stated threshold but loses information about differences in scores within each responder category. The registry does not report the distribution of the full modified Rankin Scale scores in the posted primary results. The secondary endpoint is related to the primary one, and the record does not report a multiplicity adjustment.

The registry’s design description says open label with a blinded endpoint and lists single masking, but it does not provide detailed procedures for maintaining blinded outcome assessment. Safety information is posted as counts and a serious-event term, without a statistical comparison or detailed timing and attribution information. These limitations concern the completeness of the registry reporting and should not be mistaken for proof that the unreported procedures were absent.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: A Randomized Controlled Trial of TNK-tPA Versus Standard of Care for Minor Ischemic Stroke With Proven Occlusion — NCT02398656.
• Registry record last updated 2025-01-31; status last verified 2025-01.
• Results first posted 2025-01-31.
• 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.

23. Record Summary

NCT02398656 is a completed phase 3 randomized parallel-group trial sponsored by the University of Calgary. It compared a single intravenous bolus of tenecteplase with physician-selected antiplatelet-based standard care in the setting of minor ischemic stroke with proven occlusion. The registry describes an open-label, blinded-endpoint design and a primary 90-day modified Rankin Scale responder outcome.

The sponsor reported a primary risk ratio of 0.96, with a 95% confidence interval from 0.88 to 1.04. An unadjusted recalculation from the posted counts gives a risk difference of -0.033, with a 95% confidence interval from -0.091 to 0.026. Both comparisons leave uncertainty about the direction and size of the difference. Important analysis details, including missing-data handling, analysis population, and multiplicity procedures, are not reported in the registry record.