A Trial to Compare American Heart Association (AHA) and Simple (SIM)Method to Give Adenosine to Treat Supra-ventricular Tachycardia (SVT): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Trial to Compare American Heart Association (AHA) and Simple (SIM)Method to Give Adenosine to Treat Supra-ventricular Tachycardia (SVT) (NCT04392362), a randomized phase 3 study. The primary outcome is The Number of Patients With First Dose Successful Termination of the Supraventricular Tachycardia to a Sinus Rhythm of Less Than 140 With the AHA Versus a Simplified Method of Adenosine Administration.

2. Clinical Question

3. Trial Design

This was a randomized, parallel-group trial recorded as phase 3. The registry lists an enrollment of 30 and marks the trial as completed. Its recorded start date is 2018-04-01, and its primary completion date is 2020-12-16. The sponsor is the University of Pretoria. The registry describes the allocation as randomized and the masking as none, so the trial was not masked according to the record.

Participants were assigned to an intervention group using the simplified adenosine administration method or a control group using the AHA two-syringe method. Both groups received adenosine. The intervention description states that the simplified method used 6mg followed by 12mg repeated twice and mixed the drug with 20 ml saline as a whole flush. The control description identifies the recommended AHA two-syringe method. Further details about implementation, including who administered treatment and whether co-interventions were allowed, are not reported in the registry record.

The registry lists one outcome measure and one analysis. The outcome is a binary participant count: whether first-dose administration was followed by conversion to sinus rhythm below 140 beats per minute within 10 seconds. The arm records list 23 participants in the intervention group and 7 in the control group. The registry does not describe the randomization sequence generation, allocation concealment, recruitment procedures, or reasons for the unequal group sizes. Those design details are not reported in the registry record and should not be inferred from the recorded arm counts.

Although the registry identifies the analysis as non-inferiority, it does not report the non-inferiority margin or explain how the target enrollment was selected. The planned sample-size justification and any interim analyses are not reported in the registry record. The posted enrollment therefore describes how many participants were recorded, not the basis on which the trial was designed or the precision its investigators intended to achieve.

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 The Number of Patients With First Dose Successful Termination of the Supraventricular Tachycardia to a Sinus Rhythm of Less Than 140 With the AHA Versus a Simplified Method of Adenosine Administration, measured over 10 seconds.

The primary endpoint counts participants whose supraventricular tachycardia converted to sinus rhythm below 140 beats per minute after the first dose of adenosine. The stated timeframe is 10 seconds. This is a binary endpoint: each participant either met the recorded conversion criterion or did not. The registry presents counts for each treatment group rather than a continuous measure of heart rate or time to conversion.

As a general statistical point, a binary endpoint can make the trial question concrete by defining a particular event that can be counted across groups. Here the event is first-dose conversion meeting the rhythm threshold within the specified timeframe. The outcome is relevant to the stated comparison of administration methods because the primary question concerns whether the simplified method can achieve a result that is not unacceptably worse than the standard method. However, the endpoint alone does not fully specify how non-inferiority is judged: that requires a prespecified margin and an appropriate analysis rule. The margin is not reported in the registry record.

The posted counts are 13 of 23 participants in the intervention group and 4 of 7 in the control group. These are observed event counts, not estimates of what would occur in every setting. The registry does not report additional primary-endpoint detail on how rhythm was assessed, who assessed it, how missing assessments were handled, or whether any participants were excluded from the endpoint analysis. Those operational details are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry reports a binary primary outcome, two randomized groups, and a non-inferiority analysis. It names Wilcoxon (Mann-Whitney) as the method and reports a risk ratio of 0.89, a 95% confidence level, and p = 0.898. It does not explain the exact test formulation, the coding of the groups for the risk ratio, or how the named method relates to the reported effect measure. The statistical plan and further analysis details are not reported in the registry record.

What does a binary endpoint mean?

As a general explanation, a binary endpoint classifies each participant into one of two outcome categories, such as whether a defined event occurred. The trial’s primary endpoint is a count of participants meeting its stated conversion criterion: sinus rhythm below 140 beats per minute within 10 seconds after the first dose. The reported counts are 13 in the intervention group and 4 in the control group. A count can be interpreted only in relation to the group size; the record lists 23 and 7 participants in those groups, respectively.

The registry’s analysis parameter is a risk ratio. As a general explanation, a risk ratio compares the event probabilities in two groups, with its interpretation depending on which group is placed in the numerator and how the event is coded. The record gives the value 0.89 but does not state the coding convention or clarify the group order used in that estimate. It is therefore safest to report the value as recorded without assigning a direction to the comparison beyond the registry’s stated group labels.

What does the named test tell the reader?

The listed method is Wilcoxon (Mann-Whitney). In general, this is a rank-based method for comparing distributions of observations between groups. The registry does not explain how it was applied to this binary endpoint or how it produced the reported risk ratio. It also does not describe any adjustment, exact calculation, or alternative analysis. The method name and the effect measure should therefore be treated as separate reported details rather than assuming an unreported implementation.

The p value of 0.898 is the result reported alongside the non-inferiority analysis. In general, a p value describes how compatible the observed data are with a specified statistical null model, under the assumptions of the test. Its meaning depends on the hypothesis being tested. The registry does not describe that hypothesis sufficiently to infer whether the p value tests a difference, a non-inferiority boundary, or another contrast. It cannot be interpreted as the probability that either administration method is effective or as the probability that the methods are equivalent.

Why is the confidence interval important?

A confidence interval is, as a general statistical concept, a range of values compatible with the data under a specified procedure. It conveys uncertainty around an estimated effect and is especially important in non-inferiority work, where the estimate must be considered in relation to a prespecified margin. The registry indicates a 95% confidence interval but leaves both limits blank. The interval cannot therefore be evaluated from the posted analysis, and no interval should be reconstructed from the counts without additional justified assumptions.

The non-inferiority margin is also not reported. In general, that margin is the boundary defining the largest difference that would still be considered acceptable for the non-inferiority question. A decision requires both a clearly defined boundary and an estimate with uncertainty that can be compared against it. Neither the margin nor the interval limits are available in the registry record, so the stated non-inferiority label cannot be independently checked against a decision threshold.

What is the role of the recalculation?

The posted endpoint is binary, but the registry indicates that values are missing or not estimable for a two-arm comparison of this kind. Accordingly, there is no simple unadjusted recalculated estimate to compare with the registry’s reported RR of 0.89. The absence of such a calculation is not evidence that the posted analysis is wrong; it means the available summary statistics do not yield a recalculated two-arm result under the calculation approach used for this record.

Sample-size planning illustrations, when used, are not observed power and are not a retrospective confirmation of a trial’s design. The stated planning assumptions describe a two-sided significance level of 0.05, equal allocation, a normal approximation, and an effect defined as a stated fraction of the observed effect. The registry record does not report the trial’s own sample-size justification. Planning calculations based on an observed effect are conditional illustrations, not evidence that the trial had a particular probability of detecting an effect before it began.

Over-dispersion is a general concern for some count outcomes when variability exceeds what a simple model assumes. This trial’s primary endpoint is recorded as a binary participant count, not a count of repeated events per participant, and no dispersion estimate is reported. The registry does not describe an over-dispersion assessment, and none should be inferred from the posted event 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("Intervention Group", "Control Group")
n      <- c(23, 7)
events <- c(13, 4)
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  Intervention Group  23  13  56.5  34.5  76.8  36.8  74.4  36.6  74.4
ARM  Control Group  7  4  57.1  18.4  90.1  25.0  84.2  24.5  84.3

11. Analyses Reported by the Sponsor

The registry’s reported inferential result is a risk ratio of 0.89, with p = 0.898, under an analysis labelled non-inferiority and naming Wilcoxon (Mann-Whitney). It identifies the confidence interval as 95% but does not report either limit. The registry also does not state the non-inferiority margin, the precise hypothesis, or the decision rule. Those omissions prevent an independent assessment of whether the reported analysis supports a non-inferiority conclusion.

A simple unadjusted recalculation is not estimable from the posted two-arm binary endpoint summary under the calculation approach associated with this record. There is therefore no recalculated estimate to place alongside the reported RR of 0.89. The event counts remain useful descriptive information: 13 participants in the intervention group and 4 in the control group met the primary endpoint. They do not replace the sponsor’s analysis or supply its missing interval limits and margin.

The registry’s reported analysis should be distinguished from any descriptive comparison of the counts. In particular, p = 0.898 should not be treated as the missing confidence interval or as a substitute for the non-inferiority margin. The basis for the sponsor’s analysis and its full interpretation are not reported in the registry record.

12. Multiplicity, Missing Data and Analysis Populations

The registry lists one outcome measure and one analysis, and it reports no secondary outcomes. No multiplicity adjustment or testing hierarchy is reported in the registry record. With only one posted outcome measure, the record does not show a family of additional endpoint tests, but this does not establish whether other outcomes were collected or considered outside the posted results.

The analysis population is not described. The registry does not state whether the analysis followed an intention-to-treat, per-protocol, or other population definition. This omission matters for a non-inferiority question because analysis-population choices can affect interpretation, but the record does not provide enough information to determine which population was used or whether more than one population was analyzed.

Missing-data procedures are not reported in the registry record. There is no posted count of participants with unavailable primary outcomes, no explanation of how missing assessments were handled, and no sensitivity analysis described. Participant flow, withdrawals, and exclusions from analysis are also not reported. The recorded arm sizes are 23 and 7; the record does not clarify whether these are the randomized, treated, or analyzed populations.

The registry gives an overall enrollment of 30 but does not explain the allocation process in enough detail to account for the unequal recorded arm sizes. Randomization is listed, but sequence generation and allocation concealment are not described. These registry entries limit evaluation of how well the analysis preserves the protection intended by random assignment.

The protocol’s statistical analysis plan, any prespecified subgroup analyses, interim analyses, and rules for stopping or changing analyses are not reported in the registry record. This does not establish that such procedures were or were not used. It means the posted record does not allow readers to verify whether the reported endpoint and analysis were selected before results were known or whether other planned analyses were omitted.

13. 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 non-serious adverse event terms

The registry records zero serious adverse events among 23 participants in the intervention group and zero among 7 participants in the control group. It also records zero deaths in both groups. No serious adverse event terms are listed. These are the safety counts posted for the trial; they describe what is recorded in this registry entry and should not be read as proof that serious events cannot occur.

The record separately reports other adverse events affecting 23 participants in the intervention group and 7 in the control group. The registry does not define the category of other adverse events, give event types or severity, or state how many events each affected participant experienced. The figures are counts of participants recorded as affected, not a detailed accounting of event episodes.

As a general statistical point, safety comparisons are difficult to interpret when group sizes are limited, especially for uncommon events. Zero recorded serious events in these groups leaves little information about the frequency of rare events beyond the observation period. The registry does not report additional safety follow-up details or an analysis comparing adverse-event rates. The figures should therefore be read descriptively, alongside the small recorded group sizes, rather than as a definitive comparison of safety between methods.

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

The posted results describe a randomized comparison of two adenosine administration methods in a trial enrolling 30 adults with supraventricular tachycardia. For the primary endpoint, 13 participants in the simplified-method group and 4 in the AHA two-syringe group were recorded as having first-dose conversion to sinus rhythm below 140 beats per minute within 10 seconds. These counts are the central observable outcome information in the registry record.

The registry also reports a risk ratio of 0.89 and p = 0.898, and labels the analysis non-inferiority. However, it does not report the 95% confidence interval limits or the non-inferiority margin. Consequently, the information needed to evaluate the precision of the effect and compare it with the non-inferiority boundary is missing. The label and p value alone do not establish that the simplified method met a prespecified non-inferiority criterion.

As a general statistical principle, failure to show a statistically detectable difference is not the same as demonstrating equivalence or non-inferiority. Those are distinct questions with their own hypotheses and decision thresholds. Because the margin, the analysis population, and the interval limits are not reported, the registry does not permit a complete evaluation of the stated non-inferiority question.

The results also do not settle how the findings would apply beyond the recorded trial participants. The registry gives no further eligibility details, recruitment context, or outcome-assessment procedures. The relatively limited recorded group sizes and unequal allocation constrain the amount of information available, while the lack of interval limits prevents direct evaluation of statistical precision. These limitations do not erase the observed counts, but they do narrow what those counts can establish.

Thus, the record supports a descriptive account of the trial and its reported analysis. It does not establish clinical benefit, establish lack of benefit, prove equivalence, or provide a fully assessable non-inferiority conclusion. It also does not provide enough detail to judge missing-data handling, the analysis population, or the robustness of the result under alternative assumptions.

15. Why This Trial Matters Statistically

This trial raises an important statistical distinction: comparing two methods is not automatically the same as demonstrating that one is non-inferior to the other. A non-inferiority study needs a prespecified margin that defines the largest acceptable disadvantage, along with an analysis that evaluates uncertainty relative to that margin. The registry identifies a non-inferiority analysis, but the margin and confidence interval limits are not reported. The example therefore illustrates why a label and p value are not enough to verify the intended claim.

The trial also shows why effect estimates need to be read with their underlying group sizes. The primary endpoint counts are 13 in the intervention group and 4 in the control group, with recorded group sizes of 23 and 7. Those figures provide an understandable account of what was observed, but the group sizes are unequal and the registry does not provide interval limits for the effect estimate. Statistical interpretation must account for uncertainty rather than treating raw counts as a complete comparison.

There is also a reporting lesson in the relationship between an analysis name and its output. The record names Wilcoxon (Mann-Whitney) while reporting a risk ratio for a binary endpoint, without describing how the method was implemented. A clear statistical report should make the outcome coding, estimand, test, confidence interval, and decision threshold interpretable together. When those details are absent, readers should report the result as recorded without filling gaps through assumption.

Finally, the entry highlights that a completed trial record may contain useful results while leaving important design and analysis details unavailable. The counts, group sizes, and reported p value are informative, but they do not answer every question about design quality, analysis population, missing outcomes, or non-inferiority. Careful reading separates what the record directly documents from what it does not permit readers to conclude.

16. 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 registry record does not provide the non-inferiority margin, a key element for interpreting the stated primary analysis. It gives a 95% confidence level but no confidence interval limits. Without those details, readers cannot assess whether the reported estimate and its uncertainty fall within a prespecified non-inferiority boundary. The reported p value does not fill this gap because the tested hypothesis and decision rule are not described.

The analysis method is named as Wilcoxon (Mann-Whitney), while the reported parameter is a risk ratio. The record does not explain the exact method, how it was applied to the binary endpoint, or the group and event coding for the ratio. No unadjusted recalculated estimate is available from the posted summary under the calculation approach used for this record. The reported effect measure therefore cannot be independently checked against such a recalculation.

Further trial details are missing, including eligibility criteria, sequence generation, allocation concealment, participant flow, and the analysis population. The registry does not state how missing primary outcomes were handled or whether any participants were excluded from analysis. It also does not report the trial’s own sample-size justification or interim analyses. These omissions limit assessment of design, analysis, and the possibility that the posted endpoint results represent a selected subset.

The recorded groups contain 23 and 7 participants, and no additional primary-endpoint precision measures are posted. The registry offers only limited safety detail: no serious events or deaths are recorded, while other adverse events are listed without event descriptions or a definition. These trial-specific constraints mean the findings should be interpreted as a brief registry account rather than a complete statistical report.

17. Related Tutorials

18. Related Statistical Calculators

19. Sources

• ClinicalTrials.gov: A Trial to Compare American Heart Association (AHA) and Simple (SIM)Method to Give Adenosine to Treat Supra-ventricular Tachycardia (SVT) — NCT04392362.
• Registry record last updated 2021-06-25; status last verified 2021-06.
• Results first posted 2021-06-25.
• 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.

20. Record Summary

NCT04392362 is a completed randomized, parallel-group phase 3 trial sponsored by the University of Pretoria. The registry records enrollment of 30, no masking, a start date of 2018-04-01, and a primary completion date of 2020-12-16. It compared a simplified adenosine administration method with the AHA two-syringe method in adults with supraventricular tachycardia.

The primary endpoint was first-dose conversion to sinus rhythm below 140 beats per minute within 10 seconds. The registry reports 13 participants meeting the endpoint in the intervention group, with 23 participants recorded in that group, and 4 in the control group, with 7 participants recorded. The reported analysis is labelled non-inferiority and gives RR 0.89 and p = 0.898. The confidence interval limits and non-inferiority margin are not reported in the registry record.

The entry lists no serious adverse events or deaths in either group and reports other adverse events among all participants recorded in each arm. Analysis-population details, missing-data methods, the sample-size justification, and further statistical-plan details are not reported.