Post Marketing Surveillance (PMS) of JARDIANCE in Chronic Heart Failure (CHF): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Post Marketing Surveillance (PMS) of JARDIANCE in Chronic Heart Failure (CHF) (NCT05262764), a registered phase not stated study. The primary outcome is Number of Subjects With Adverse Drug Reactions (ADRs).

2. Clinical Question

In practical terms, this is a surveillance question: what safety events were recorded among eligible patients receiving JARDIANCE® in routine care? The registry also lists all-cause death, cardiovascular death, and hospitalization for heart failure as secondary outcomes. Those outcomes could describe events observed during follow-up, but without a comparator they cannot establish how many would have occurred in the absence of treatment or under another treatment.

The registry lists an enrollment of 1200. That figure is not interchangeable with the safety-set count used in the adverse-event reporting, and it should not be read as the denominator for every outcome. The record does not report enough detail to determine how participants contributed to each endpoint or whether outcome follow-up was complete for everyone.

3. Trial Design

NCT05262764 is a post-marketing surveillance study of JARDIANCE® in chronic heart failure in Japan. Its stated objective is to investigate the safety and effectiveness of long-term daily use under real-world conditions. The registry lists Boehringer Ingelheim as sponsor and gives the study status as completed. The recorded start date is 2022-04-15, and the primary completion date is 2024-06-21.

The registry describes one JARDIANCE® group: patients with chronic heart failure who had not previously received empagliflozin and were prescribed JARDIANCE® tablets. Treatment was in accordance with the latest guidelines from The Japanese Circulation Society. The planned observation period was up to 52 weeks after treatment start. A protocol-level description of how prescribing decisions were made, how outcomes were collected, or whether follow-up could continue beyond this period is not reported in the registry record.

This is not a randomized comparison. The allocation method is not stated, and no control arm is described. The design therefore supports a description of recorded outcomes among the monitored patients, rather than an estimate of the causal difference between treatment strategies. Routine-care surveillance can capture events in a clinical setting, but treatment selection, patient characteristics, and the intensity of follow-up may differ from those in a controlled comparison.

The registry lists an enrollment of 1200, while the safety endpoint description specifies a safety set that excludes patients with important protocol deviations concerning safety and regulatory issues. The posted serious adverse-event figures use 1166 as the at-risk count. These counts have distinct roles and should not be substituted for one another. The record does not provide further participant flow details or explain the relationship between the enrollment and the reported safety denominator.

The registry lists four outcome measures and zero analysis entries. A detailed statistical analysis plan, including model specifications, covariate adjustment, handling of repeated events, or rules for censoring, is 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.

Before assignment: This was a non-interventional, single arm study based on newly collected data Patients were observed for up to 52 weeks after start of the treatment with JARDIANCE® Tablets or until discontinuation of administration. Out of the 1200 registered subjects, 1166 had no protocol violations and were included in the safety set.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Safety set: all patients who didn't have important Protocol Deviations regarding safety and regulatory issues.

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: Safety set: all patients who didn't have important Protocol Deviations regarding safety and regulatory issues.

6. Primary Endpoint

The registry lists the primary outcome as Number of Subjects With Adverse Drug Reactions (ADRs), measured over Up to 52 weeks.

The primary endpoint is the number of participants with adverse drug reactions (ADRs), measured as a participant count over follow-up of up to 52 weeks. The description highlights hypoglycaemia, events relevant for volume depletion, increased ketone bodies or ketoacidosis, and renal impairment. The endpoint is intended to summarize whether participants experienced reactions considered adverse drug reactions during the surveillance period.

A participant count is a way to describe how many people had at least one qualifying event, rather than the total number of event episodes. If one person experiences repeated events, a participant-based endpoint generally counts that person once for the endpoint, depending on the study’s definitions. The registry record does not report the operational rules used to classify an event as an ADR, how repeated events were handled, or how attribution to treatment was assessed.

Safety endpoints of this kind are used in surveillance because they can identify and characterize events recorded during exposure in routine practice. They are descriptive in a single-arm study: they show what was observed in the monitored group, not what would have happened to the same patients under a different treatment or without treatment. The registry record does not report a numerical result for the primary ADR endpoint in the endpoint description. The serious adverse-event figures should not automatically be treated as the primary ADR result, because serious adverse events and ADRs are distinct categories and the record does not establish that they are identical.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What a participant count conveys. The primary endpoint is a count of participants with ADRs, not a measure of how severe an event was or how many separate episodes occurred. In general, participant-based counts are useful for answering whether people experienced at least one qualifying event within the observation period. They can be easier to interpret than a tally of episodes when individuals may have repeated events. The exact counting convention depends on the protocol. The registry record does not report whether every participant with repeated events was counted once, how event onset and follow-up were defined, or how ADR attribution was decided.

Why a denominator matters. A count becomes interpretable as a frequency only when its population at risk and observation rules are clear. The record describes the primary endpoint population as the safety set and gives a definition based on exclusions for important protocol deviations concerning safety and regulatory issues. The serious adverse-event summary separately reports 1166 at risk and 148 affected. The enrollment entry of 1200 is not the same as an endpoint-specific denominator. No detailed participant-flow accounting or endpoint-by-endpoint denominator explanation is reported in the registry record.

Counts, percentages, and event categories. The serious-event list includes percentages for named terms. Such percentages can communicate the relative frequency of reported categories, but their interpretation depends on how terms were coded and on whether the denominator is participants, events, or another unit. The registry record does not state those details for the listed terms. A participant may also have more than one event or more than one coded term; the available description does not establish whether categories are mutually exclusive. Accordingly, percentages should be treated as registry summaries rather than as mutually exclusive parts of a whole.

Serious adverse events versus ADRs. Seriousness and suspected relationship to treatment are different dimensions of safety reporting. A serious adverse event is classified by seriousness criteria; an ADR is an adverse reaction attributed to treatment under the study’s definitions. An event could belong to one category without necessarily belonging to the other. Since the primary endpoint is ADRs and the reported group figures concern serious adverse events, the two should not be combined or assumed to be equivalent. Detailed adjudication and attribution procedures are not reported in the registry record.

Uncertainty and comparison. In general, a confidence interval describes the range of effect estimates compatible with the data under a statistical model and its assumptions. It helps distinguish a relatively precise estimate from one with substantial uncertainty. The registry information summarized for this study does not report confidence intervals for the counts or term percentages. The study also has no described comparison group, so it cannot directly estimate a treatment contrast. In a single-arm surveillance study, a descriptive frequency may reflect the treated population and its clinical context; it is not a causal estimate of treatment effect.

Over-dispersion and event counts. In general, models for counts often begin with assumptions about the relationship between the mean and the variability. If observed variability is greater than a model expects, over-dispersion can make conventional uncertainty estimates too narrow unless the method accounts for it. That issue is most relevant when modeling numbers of event episodes. The primary endpoint is described as a number of participants with an event, and the registry does not report a count model, an over-dispersion assessment, or a model-based analysis. No inference about the analysis method should be made from the endpoint format alone.

Planning illustrations are not observed power. A sample-size illustration based on an observed effect is a hypothetical planning calculation. It is not a measure of the probability that this completed study detected a true effect, and it does not replace a protocol’s original sample-size rationale. The assumptions described for such illustrations include a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the target effect expressed as a fraction of the observed effect. These are planning assumptions, not evidence that this one-group surveillance study used that design. The registry record does not report the study’s own sample-size justification or a matching two-arm comparison.

Analysis plan and interpretation. The registry lists four outcome measures and zero analysis entries. It does not report the statistical analysis plan, prespecified covariates, treatment of repeated observations, interim analyses, or adjustment for multiple outcomes. In general, those choices affect how estimates and uncertainty should be interpreted. In their absence, the defensible approach is to describe the reported counts and categories without implying a model-based or causal conclusion. The record’s completed status does not fill in these methodological details.

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®")
n      <- c(1166)
events <- c(61)
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®  1166  61  5.2  4.0  6.7  4.1  6.7  4.1  6.7

11. Multiplicity, Missing Data and Analysis Populations

The registry lists four outcome measures, including the primary ADR endpoint and secondary outcomes for all-cause death, cardiovascular death, and hospitalization for heart failure. When several outcomes are examined, multiplicity can arise because there are multiple opportunities to identify an apparently unusual result. In general, a prespecified testing hierarchy or adjustment method can help control the interpretation of a family of statistical tests. The registry record does not report a multiplicity strategy, a testing hierarchy, or adjusted estimates. It also lists zero analysis entries, so a detailed account of which outcomes were formally tested is not available.

Missing-data handling is not described. The record does not report the amount or pattern of missing outcome information, reasons for missingness, rules for excluding participants from particular analyses, or any imputation method. This matters because incomplete observation can affect the apparent frequency of events, especially when follow-up time differs among participants. The planned observation was up to 52 weeks, but the record does not specify the completeness of individual follow-up or how participants who stopped observation were handled.

The primary endpoint population is described as the safety set, excluding patients with important protocol deviations regarding safety and regulatory issues. The serious-event figures use an at-risk count of 1166, while enrollment is listed as 1200. The registry record does not explain participant flow between these quantities or state whether outcome-specific analysis populations differed. No adjusted analyses or sensitivity analyses are reported. Consequently, the reported summaries should be interpreted as registry descriptions, with uncertainty about missingness, population definitions, and multiplicity left unresolved.

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: cardiac failure (5.0%), atrial fibrillation (0.6%), covid-19 (0.5%), pneumonia (0.5%), cerebral infarction (0.5%).

The JARDIANCE® serious adverse-event summary reports 1166 at risk and 148 affected. The registry also reports 30 deaths. These figures describe the posted safety record; they do not establish that every event was caused by treatment. The record does not give a comparator group, so there is no within-study basis for contrasting these counts with outcomes under another treatment or no treatment.

The listed serious-event terms are Cardiac failure at 5.0%, Atrial fibrillation at 0.6%, COVID-19 at 0.5%, Pneumonia at 0.5%, Cerebral infarction at 0.5%, and Cardiac failure chronic at 0.4%. The registry record does not specify the denominator or coding details behind each percentage. The terms also should not be added together: the record does not establish that categories are mutually exclusive, and a participant may be represented under more than one term.

Serious adverse events are not interchangeable with adverse drug reactions. Seriousness describes an event category, while an ADR concerns a suspected relationship to treatment. The primary endpoint is the number of participants with ADRs, but the serious-event summary does not itself give that primary endpoint result. Event attribution, recurrence handling, and details of follow-up are not reported in the registry record.

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

The study contributes a real-world surveillance description of JARDIANCE® use among patients in Japan with chronic heart failure who had not previously been treated with empagliflozin. The registry states that the study was intended to investigate safety and effectiveness during long-term daily use, with observation for up to 52 weeks. Its serious adverse-event summary gives the at-risk and affected counts and lists common serious-event terms. Those details help characterize what was recorded in the monitored group.

The record does not establish whether JARDIANCE® caused any particular event, changed the risk of an event, or performed differently from another treatment. There is no described comparator group, the allocation method is not stated, and the study is not a randomized comparison. A count observed after treatment is not, by itself, a causal effect. The health status of the participants, their underlying heart failure, other care, and routine-practice circumstances may all contribute to events recorded during follow-up.

The primary endpoint is described as a participant count for ADRs, but its numerical result is not stated in the endpoint description. The serious adverse-event figures should not be substituted for that endpoint because the categories are not identical by definition. The registry also lists death and heart-failure hospitalization outcomes, but the record does not give comparative estimates for them.

Interpretation is further limited by the absence of a detailed analysis plan, confidence intervals, missing-data information, and explanation of endpoint-specific denominators. The registry lists enrollment of 1200, while the serious-event summary uses 1166 at risk; without participant-flow detail, these values should not be treated as interchangeable. The results therefore support a description of reported events in this surveillance group, not a definitive estimate of treatment benefit or harm relative to an alternative.

14. Why This Trial Matters Statistically

Post-marketing surveillance addresses a different statistical question from a randomized trial. It can describe safety information collected during treatment in routine practice, where patients and care may reflect clinical use rather than a tightly controlled comparison. This makes the distinction between observed event frequency and causal treatment effect especially important. The Japanese setting, chronic heart failure population, and focus on patients without prior empagliflozin treatment define the group to which the registry description applies.

Several parts of the record illustrate why outcome definitions and analysis populations matter. The primary endpoint is a participant count for ADRs, while the posted serious adverse-event figures describe a different safety category. The primary endpoint population is defined as a safety set, and the serious-event summary has its own at-risk count. Keeping those quantities separate prevents a broad enrollment figure from being mistaken for an endpoint-specific denominator and prevents serious events from being treated as synonymous with treatment reactions.

The listed secondary outcomes—death and hospitalization for heart failure—are clinically important events to monitor, but their presence in a registry does not establish that each was analyzed or that a treatment effect was estimated. The record lists zero analysis entries and does not report a detailed statistical plan. Clear reporting of populations, follow-up, missing outcomes, event definitions, and uncertainty would help readers judge the precision and scope of the surveillance findings.

Thus, the statistical value of the record is chiefly descriptive. It documents the study’s intended safety focus, its real-world surveillance setting, and certain recorded serious-event summaries. It also demonstrates why a one-group count cannot answer the same question as a controlled estimate of comparative risk.

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.

This study has no described comparator group and is not a randomized comparison. Allocation is not stated. As a result, recorded events cannot be attributed to JARDIANCE® on the basis of these data alone, and there is no like-for-like estimate against another treatment. Differences in patient characteristics, other care, or clinical circumstances could influence the observed event profile.

The primary endpoint is defined as participants with ADRs, but the endpoint description does not state its numerical result. Serious adverse-event figures are available, but serious events and ADRs are not equivalent categories. The registry does not report the event-attribution process, coding rules, recurrence handling, or the denominator used for each term percentage. These omissions constrain interpretation of both the endpoint and the serious-event list.

Enrollment is listed as 1200, while the serious adverse-event summary reports 1166 at risk. Although the primary safety population definition is described, participant flow and endpoint-specific analysis populations are not. The completeness of follow-up through the planned period of up to 52 weeks, the extent of missing data, and the handling of incomplete observations are not reported in the registry record.

The registry lists four outcome measures and zero analysis entries. It does not report confidence intervals, a detailed statistical analysis plan, adjustment for multiple outcomes, or sensitivity analyses. The study’s sample-size justification and any interim analyses are also not reported in the registry record. These limitations mean the posted information is best read as descriptive surveillance, with limited ability to assess precision or infer comparative treatment effects.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Post Marketing Surveillance (PMS) of JARDIANCE in Chronic Heart Failure (CHF) — NCT05262764.
• Registry record last updated 2026-03-24; status last verified 2026-03.
• Results first posted 2025-08-06.
• 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

NCT05262764 is a completed post-marketing surveillance study sponsored by Boehringer Ingelheim. It concerns long-term daily JARDIANCE® use among patients in Japan with chronic heart failure who had not previously received empagliflozin. The registry lists enrollment of 1200, a study start date of 2022-04-15, and a primary completion date of 2024-06-21. Treatment was described as following the latest guidelines from The Japanese Circulation Society, with observation planned for up to 52 weeks.

The primary endpoint is the number of participants with ADRs in a safety set. Secondary outcomes include all-cause death, cardiovascular death, and hospitalization for heart failure. The serious adverse-event summary reports 1166 at risk, 148 affected, and 30 deaths, alongside term-specific percentages. The registry does not describe a comparator, detailed analysis plan, missing-data handling, or uncertainty estimates. Its results should therefore be read as descriptive observations from a single-group surveillance study.