JARDIANCE® Post Marketing Surveillance in Korean Patients With Chronic Kidney Disease (CKD): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for JARDIANCE® Post Marketing Surveillance in Korean Patients With Chronic Kidney Disease (CKD) (NCT06287073), a registered phase not stated study. The primary outcome is Number of Participants With Adverse Events (AEs).

2. Clinical Question

The central statistical question is descriptive: what adverse-event experience was recorded among the patients who entered the safety set and were followed in this surveillance study? The posted results report 6 participants with serious adverse events among 273 at risk, 0 participants with other adverse events among 273 at risk, and 0 deaths. The registry also lists six serious-event terms, each with a reported frequency of 0.4%. These counts describe events observed and recorded during follow-up; they do not estimate what would have happened to the same patients under a different treatment or without treatment.

The record identifies follow-up for the primary safety outcome as up to 337 days. It does not report a separate control group, a randomized assignment, or a comparative effect estimate. Consequently, the information answers a monitoring question in routine practice, rather than a causal treatment-comparison question. The efficacy objective is described, but the numerical UACR findings are not reported in the registry record. The extent to which follow-up, outcome assessment, and patient inclusion may affect the observed counts should therefore be considered when interpreting the surveillance findings.

3. Trial Design

This is a regulatory, non-interventional post-marketing surveillance study of JARDIANCE® in Korean patients with chronic kidney disease. Its stated purpose was to monitor safety in routine clinical practice and, as a secondary objective, to monitor efficacy using changes in UACR. The registry lists one treated group: patients starting JARDIANCE® for the first time in accordance with the approved Korean label. Treatment was according to routine clinical practice rather than assigned by a trial randomization procedure.

The registry reports enrollment of 299 and a status of COMPLETED. The recorded study start is 2024-03-29, and primary completion is 2025-04-30. These dates describe the registry record; they do not establish that every enrolled participant had the same follow-up duration. The primary safety outcome has a timeframe of up to 337 days. The safety set was defined by consent, taking JARDIANCE® at least once, and at least one physician follow-up; that set contained 273 patients. Thus the enrollment figure and the primary safety denominator describe different recorded quantities.

No randomized comparison or comparator group is described. The registry's allocation information is not stated, and the listed study arm is a treated-patient group. The results should therefore be understood as observations within a treated cohort, not as a controlled estimate of a treatment difference. Differences between people who receive a treatment and those who do not could reflect patient characteristics, care decisions, or other factors; without a suitable comparison design, their contributions cannot be separated from treatment exposure using these counts alone.

The registry lists 14 outcome measures and 2 analyses. The primary outcome is the number of participants with adverse events. The secondary UACR outcome is described as change from baseline after 12 weeks and 24 weeks of treatment, but the numerical results and detailed analysis methods are not reported in the registry record. Information about eligibility criteria beyond the arm description, recruitment procedures, the timing of every safety assessment, and the protocol's statistical plan is also not reported in the registry record. The design is useful for describing recorded safety experience in practice, but it does not by itself support a controlled causal conclusion.

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: All subjects were screened for eligibility prior to participation in the trial. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated. Out of the 299 enrolled subjects, 26 subjects were not included in the safety set.

Overall Study

Analysis population for the primary outcome, as defined in the registry: The safety set included all patients who signed the data release consent form to participate in this study, took JARDIANCE® once at least, and were followed up by the physician once or more.

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

Population: The safety set included all patients who signed the data release consent form to participate in this study, took JARDIANCE® once at least, and were followed up by the physician once or more.

6. Primary Endpoint

The registry lists the primary outcome as Number of Participants With Adverse Events (AEs), measured over Up to 337 days..

The primary endpoint is the number of participants with adverse events. It is a participant-count outcome: it records whether participants experienced an event during the specified safety follow-up, rather than measuring a continuous quantity such as laboratory concentration. The registry defines the safety set as patients who signed a data release consent form, took JARDIANCE® at least once, and had at least one physician follow-up. The primary outcome timeframe is up to 337 days.

Participant counts are used in safety surveillance because they provide a direct description of how many people in the observed group had recorded events. They can be informative for monitoring when a treatment is used in routine care, especially when the study's objective is to characterize reported safety experience rather than test a randomized comparison. Such a count does not, by itself, show how frequently events would have occurred without treatment. Nor does it necessarily give the total number of event episodes: one participant may have more than one event, while a participant-level count generally counts that person as having an event.

The posted safety details report serious and other adverse events separately. The registry reports 6 participants with serious adverse events among 273 at risk, 0 with other adverse events among 273 at risk, and 0 deaths. The record does not state in the material available for this outcome whether these categories are mutually exclusive or how all adverse-event categories contribute to an overall participant count. A combined count should therefore not be inferred from the separate figures.

The secondary endpoint concerns change in UACR from baseline after 12 and/or 24 weeks. UACR is the measurement named in the registry for monitoring the secondary efficacy objective. Numerical estimates, variability measures, and analysis details for this outcome are not reported in the registry record, so its observed direction and precision cannot be described.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies a participant-count primary outcome: the number of participants with adverse events. This is a binary outcome at the participant level. For each person, the underlying status is whether an event was recorded during the relevant observation period; results may then be presented as counts and, where available, proportions. In this record, the safety results distinguish serious adverse events from other adverse events. The posted figures are 6 of 273 for serious adverse events, 0 of 273 for other adverse events, and 0 deaths. No additional precision measure for those results is reported in the registry record.

What does a participant count capture?

A participant count describes how many people had at least one event in a defined group and period. It is different from an event count, which could include repeat episodes in the same person. It is also different from a rate based on person-time, which incorporates the amount of time each participant was observed. The registry names the primary measure as the number of participants with adverse events and gives a timeframe of up to 337 days. A person-time rate or a separate analysis of repeat events is not reported in the registry record.

For a binary outcome, an estimated proportion is often accompanied by a confidence interval. In general, a confidence interval gives a range of values compatible with the data and an assumed statistical method; it reflects sampling uncertainty, not every source of bias or measurement error. With uncommon events, estimates can be imprecise, and intervals may be wide. The record does not report confidence intervals for these adverse-event findings, so the precision cannot be fully evaluated from the counts alone. General statistical interpretation should distinguish the observed count from the uncertainty around a population-level estimate.

Why does the study design affect interpretation?

This is non-interventional surveillance, with a treated-patient group and no comparator group described. In general, randomization can help balance measured and unmeasured factors between comparison groups. A single treated cohort does not provide that protection and cannot directly show what would have happened to the same people under another treatment strategy. Observed events may reflect underlying illness, other care, patient characteristics, treatment exposure, or a combination of factors. The registry record does not report an adjusted comparative analysis that could address these issues.

The safety population is defined by consent, at least one dose, and at least one physician follow-up. This definition is important because it determines which patients contribute to the reported safety denominator. The enrollment count is 299, whereas the safety set contains 273 patients. The reasons for the different counts and the outcome status of patients outside the safety set are not reported in the registry record. General analysis practice calls for clear accounting of participants included in each outcome analysis, because different inclusion rules can affect interpretation.

What can be said about planning calculations?

The stated planning illustration uses a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It describes an effect to detect as a stated fraction of the observed effect. Such a calculation is a planning exercise: it asks what sample size might be needed under specified assumptions for a hypothetical comparison. It is not an observed study result, and it is not observed power. Since the registry describes a single treated cohort rather than a randomized two-arm comparison, the illustration should not be mistaken for the design or analysis actually used in this surveillance study. The registry record does not report a protocol-based sample-size justification or a comparative effect estimate for this trial.

In general, a planning calculation depends on the assumed event frequency, effect size, significance level, allocation, and statistical model. A smaller effect to detect usually requires more participants under otherwise unchanged assumptions, and departures from assumptions can change the required sample size. The stated illustration uses the observed effect as its reference, but a numerical observed effect for a controlled comparison is not reported in the registry record. Any sample-size interpretation should therefore remain separate from the observed surveillance counts.

Why can variation exceed a simple model's assumptions?

General statistical models often make assumptions about how observations vary and whether outcomes are independent. Over-dispersion means the observed variability is greater than a model expects; if ignored, uncertainty estimates can be too small and intervals or tests can be misleading. This concept is relevant in settings with clustered observations, repeated events, or heterogeneous patients. The registry does not report that an over-dispersion model was used, nor does it report repeated-event modeling. It should not be inferred from the participant counts that any particular model was fitted.

The record lists 14 outcome measures and 2 analyses. In general, examining multiple outcomes or conducting multiple tests raises a multiplicity question: the chance of at least one apparently unusual result can increase as the number of tests grows. Statistical plans may address this through prespecification, adjusted thresholds, or a hierarchy of outcomes. Whether any such approach was used is not reported in the registry record. Counts of outcomes and analyses alone do not reveal the testing strategy.

Finally, data completeness, event adjudication, coding rules, and follow-up procedures affect interpretation of surveillance data. A reported zero can mean no events were recorded in the analyzed set under the study's ascertainment process; it does not prove that the true risk is zero. Missing-data handling, the amount of missing information, and sensitivity analyses are not reported in the registry record. These omissions limit assessment of precision and robustness, independently of the descriptive counts.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("JARDIANCE® Treated Patients")
n      <- c(273)
events <- c(46)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  JARDIANCE® Treated Patients  273  46  16.8  12.6  21.8  12.9  21.7  12.9  21.8

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 14 outcome measures and 2 analyses. Considering multiple outcomes can create a multiplicity issue: when many statistical questions are examined, the likelihood of finding at least one apparently notable result may rise. General approaches include defining a primary outcome in advance, controlling an overall error rate, or treating additional outcomes as exploratory. The registry identifies a primary safety outcome and a secondary UACR objective, but a multiplicity adjustment or testing hierarchy is not reported in the registry record. The number of listed outcomes alone does not establish that statistical significance testing was conducted or adjusted.

Missing-data information is also limited. The safety set includes patients who signed a data release consent form, took JARDIANCE® at least once, and had one or more physician follow-ups. Enrollment is 299 and the defined safety set contains 273 patients, but reasons for the difference and the status of patients outside the safety set are not reported in the registry record. The record does not describe missing outcome values, loss to follow-up, the handling of incomplete follow-up, imputation, or sensitivity analyses. Without those details, it is not possible to assess whether the analyzed patients differ in relevant ways from those not included.

Analysis-population rules can affect which observations contribute to a result. The safety population is explicitly described, but the analysis population for the UACR outcome and the handling of measurements at 12 and/or 24 weeks are not reported in the registry record. The record also does not specify whether all eligible measurements were used, how baseline values were defined, or how missing follow-up values were treated. These omissions mean the reported safety counts can be interpreted within the stated safety-set definition, while the completeness and analysis basis of the secondary outcome remain unclear.

12. 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 5% reporting threshold.

Most frequent serious adverse event terms

Serious events with the highest arm-level rate: glomerulonephritis chronic (0.4%), nephrolithiasis (0.4%), atrial fibrillation (0.4%), gastric ulcer haemorrhage (0.4%), hepatic cyst (0.4%).

The registry reports 6 participants with serious adverse events among 273 in the safety set. It reports 0 participants with other adverse events among 273 and 0 deaths. The serious-event terms listed are Glomerulonephritis chronic, Nephrolithiasis, Atrial fibrillation, Gastric ulcer haemorrhage, Hepatic cyst, and COVID-19; each term is reported at 0.4%. The record does not provide a confidence interval for these frequencies.

These figures describe the events recorded during the study's safety follow-up, which was up to 337 days. The term-specific percentages are rounded as reported. They should not be treated as evidence that each event was caused by JARDIANCE®: the study is non-interventional and does not describe a comparator group. A listed event may occur in the context of chronic kidney disease, other health conditions, concurrent care, or treatment; the registry figures alone cannot distinguish those explanations.

The six serious-event terms should not be assumed to represent six distinct participants, or to account for every serious event, unless the registry's counting rules establish that. Likewise, the serious and other event categories should not be added to obtain a combined adverse-event count because the record does not report whether the categories are mutually exclusive or how repeat events were handled. A count of participants with an event also differs from a count of all event episodes.

Zero deaths means none are reported in the posted results for this safety set. It does not establish that the risk is absent, particularly without a stated precision interval and complete details about follow-up and event ascertainment.

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

The posted findings mean that the registry recorded serious adverse events in 6 participants in the defined safety set, reported no participants with other adverse events in that set, and reported no deaths. Six serious-event terms are listed, each at 0.4%. These are descriptive safety observations for a treated cohort followed for up to 337 days. They are not a randomized comparison, a treatment effect estimate, or a complete account of all possible outcomes in every patient with chronic kidney disease.

The figures do not establish that JARDIANCE® caused or prevented any listed event. The study does not identify a comparator group, and routine-care surveillance cannot isolate treatment effects from the influences of illness, patient characteristics, and other care using the reported counts alone. The numbers also do not establish that the treatment is safe or unsafe for an individual, and they should not be used as a substitute for clinical judgment.

The absence of reported other adverse events or deaths in this cohort should not be interpreted as proof that such events cannot occur. Rare events may not appear in a cohort of this size, and the precision of the reported findings cannot be judged fully because confidence intervals are not reported in the registry record. The study's event ascertainment and missing-data procedures are also not described in enough detail to evaluate how completely events were captured.

The record's secondary objective was to monitor UACR change after 12 and/or 24 weeks. Numerical results for that outcome are not reported in the registry record, so no conclusion about the direction, size, or precision of UACR changes can be drawn from the available results. The registry also does not report a comparative analysis for that outcome.

In short, the posted data document a set of observed safety counts in a Korean routine-practice cohort. They do not estimate a causal effect versus another treatment, establish a zero risk, or provide numerical evidence about the stated UACR objective. Those boundaries are central to interpreting a non-interventional surveillance record.

14. Why This Trial Matters Statistically

Post-marketing surveillance addresses a practical statistical question: what events are recorded when a treatment is used in routine clinical care among a specified patient group? This study focuses on Korean patients with chronic kidney disease starting JARDIANCE® in accordance with the approved label. Its non-interventional design gives the record a descriptive role: it can document safety observations in practice, while not furnishing the same type of controlled treatment contrast as a randomized comparison.

The record also illustrates why analysis populations matter. Enrollment is reported as 299, whereas the safety set is defined by consent, at least one dose, and at least one physician follow-up and contains 273 patients. Readers need the population definition alongside the event count to understand who contributes to the denominator. Without information on why patients are not included in that set, the impact of selection cannot be fully assessed.

Event counts are useful but need context. Serious events are uncommon enough in this record that the posted result consists of a small number of participants and rounded term-specific frequencies. Without confidence intervals, complete follow-up details, and event-ascertainment procedures, the precision and completeness of these observations are difficult to judge. This is a general lesson for safety surveillance: a count describes what was recorded, while uncertainty and data-collection methods determine how far it can be generalized.

The registry states a secondary UACR objective but does not report numerical findings for it. Keeping stated objectives distinct from posted results is important: an outcome's presence in a protocol or registry description is not itself evidence about its observed value. Similarly, a hypothetical planning calculation is not the study's observed power and does not transform a single treated group into a comparison design.

For biostatisticians and clinical researchers, the record is a useful case in matching interpretation to design. It supports a description of reported safety experience in the defined cohort. It does not support a causal treatment comparison, a claim of zero risk, or conclusions about UACR change without numerical results. Clear population definitions, uncertainty reporting, complete outcome reporting, and transparent missing-data methods would strengthen interpretation of surveillance findings.

15. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The principal limitation is the absence of a comparator group. The study is non-interventional and describes one treated cohort, so the posted counts cannot establish what would have occurred under another treatment or without treatment. The record does not report an adjusted comparative analysis. Confounding by patient characteristics, underlying illness, and other care therefore cannot be separated from treatment exposure using these results.

The safety findings apply to the defined safety set, not automatically to all enrolled patients or to every Korean patient with chronic kidney disease. Enrollment is reported as 299 and the safety set as 273; reasons for the different counts, characteristics of patients outside the safety set, and their outcome status are not reported in the registry record. The definition also requires at least one physician follow-up, which may affect who contributes to the safety results.

Follow-up is described as up to 337 days, but individual follow-up duration, completeness of observation, and loss-to-follow-up details are not reported in the registry record. The event-collection procedures, coding rules, adjudication process, and handling of repeat events are also not reported. Those details matter when interpreting zero counts and the relationship between listed event terms and affected participants.

Uncertainty measures for the posted safety counts are not reported. The record does not provide confidence intervals or other precision estimates, making it difficult to judge the range of values compatible with these observations. The secondary UACR objective is described, but numerical outcome results and its analysis population are not reported in the registry record. Multiplicity handling, missing-data methods, and sensitivity analyses are not reported either.

Finally, the stated planning illustration uses a hypothetical two-arm framework, while the study record describes a treated cohort without a comparator. It should not be interpreted as evidence that the surveillance study was designed or powered for a controlled comparison. A protocol-based sample-size justification is not reported in the registry record.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: JARDIANCE® Post Marketing Surveillance in Korean Patients With Chronic Kidney Disease (CKD) — NCT06287073.
• Registry record last updated 2026-06-23; status last verified 2026-05.
• Results first posted 2026-06-23.
• 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.

19. Record Summary

NCT06287073 is a completed, non-interventional post-marketing surveillance study of JARDIANCE® (empagliflozin 10 mg) in Korean patients with chronic kidney disease. The stated primary objective was to monitor safety in routine clinical practice; the secondary objective was to monitor UACR change after 12 and/or 24 weeks. Enrollment was 299, and the defined safety set included 273 patients. The primary safety timeframe was up to 337 days.

The posted safety findings report 6 participants with serious adverse events, 0 with other adverse events, and 0 deaths. Six serious-event terms are listed, each at 0.4%. Numerical UACR results, confidence intervals for the safety findings, detailed missing-data methods, and a comparative treatment analysis are not reported in the registry record. The observations are descriptive and should be interpreted within the study's treated-cohort design.