This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Targeting Cellular Senescence With Senolytics to Improve Skeletal Health in Older Humans (NCT04313634), a randomized phase 2 study. The primary outcome is Change in C-terminal Telopeptide of Type I Collagen [CTX].
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04313634 |
| Phase | Phase 2 |
| Condition | Healthy |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 74 |
| Arms in the primary outcome | 3 |
| Lead sponsor | Sundeep Khosla, M.D. |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns healthy older women, as described in the registry summary and condition listing. The registry record does not report a more specific age range or additional participant characteristics in the registry record for this analysis. Enrollment was 74.
Intervention
The trial included a dasatinib-plus-quercetin group and a fisetin group. The registry describes intermittent oral dosing over 20 weeks. The dasatinib-plus-quercetin description lists dasatinib at 100 mg for two days and quercetin at 1000 mg total daily for three consecutive days. The fisetin description lists approximately 20 mg/kg/day for three consecutive days. Both descriptions refer to dosing periods starting every 28 days, with no-therapy periods between regimens.
Comparator
The untreated control group received no intervention. This provides a comparison for interpreting the observed marker changes, but the open-label design means participants and study staff were not masked to treatment assignment, according to the registry’s design information.
Primary question
The primary endpoint asks how serum CTX changed from baseline to 20 weeks. CTX is a marker of bone turnover, and the registry describes the study’s broader aim as assessing whether senolytic drugs reduce senescent-cell burden and affect bone-resorption and bone-formation markers. The posted primary results give median percent changes for each group. The registry reports a Wilcoxon (Mann-Whitney) comparison of dasatinib plus quercetin with untreated control, with p = 0.611. That result concerns the reported comparison and does not establish equivalence or settle the broader biological questions.
3. Trial Design
This was a Phase 2, single-center, randomized, open-label, parallel-group trial. The registry lists the study as completed and records enrollment of 74. The recorded start date is 2020-06-09, and the primary completion date is 2023-06-06. The title specifies a 20-week trial. Random allocation means assignment was by chance, while the parallel-group structure means participants were assigned to a treatment group or untreated control rather than crossing between conditions. The registry records no masking.
The treatment groups were dasatinib plus quercetin and fisetin; the comparator was an untreated control. The registry descriptions characterize both drug regimens as intermittent and oral, with dosing periods starting every 28 days and no-therapy periods between regimens. The descriptions state that treatment was repeated over 20 weeks and refer to five total dosing periods, although the available wording for each description is truncated. The record therefore does not establish additional details beyond the text it contains.
The enrollment figure and the group-specific counts accompanying the primary outcome are not identical sets of numbers. The CTX results list 28 for dasatinib plus quercetin, 11 for fisetin, and 28 for untreated control. Those outcome counts should not be treated as an explanation of enrollment or as proof of the analysis population: the registry record does not report why the counts differ or specify which analysis population was used.
The registry lists six outcome measures and five posted secondary outcomes. The primary endpoint is percent change in CTX from baseline to 20 weeks. Other listed outcomes concern bone-turnover markers, bone mineral density, and plasma senescence-associated secretory phenotype. The registry record does not report enough detail to reconstruct the complete protocol, allocation procedures, or analysis plan.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Dasatinib Plus Quercetin Treatment Goup | Fisetin Treatment Group | Untreated Control Group |
|---|---|---|---|
| STARTED | 30 | 14 | 30 |
| COMPLETED | 27 | 12 | 28 |
| NOT COMPLETED | 3 | 2 | 2 |
Reasons for not completing this period:
| Reason | Dasatinib Plus Quercetin Treatment Goup | Fisetin Treatment Group | Untreated Control Group |
|---|---|---|---|
| Adverse Event | 2 | 2 | 0 |
| Withdrawal by Subject | 1 | 0 | 1 |
| Protocol Violation | 0 | 0 | 1 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Dasatinib Plus Quercetin Treatment Goup | Fisetin Treatment Group | Untreated Control Group | Total |
|---|---|---|---|---|---|
| Participants analysed | 30 | 14 | 30 | 74 | |
| Age, Continuous | years | 71.2 (SD 4.9) | 75.9 (SD 3.7) | 74.4 (SD 6.7) | 73.7 (SD 5.7) |
| Sex: Female, Male: Female | Participants | 30 | 14 | 30 | 74 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 30 | 14 | 30 | 74 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 1 | 0 | 0 | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): White | Participants | 29 | 14 | 30 | 73 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
| Region of Enrollment: United States | participants | 30 | 14 | 30 | 74 |
6. Primary Endpoint
The registry lists the primary outcome as Change in C-terminal Telopeptide of Type I Collagen [CTX], measured over Baseline, 20 weeks.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Full Range |
| Unit | percent change |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is percent change in serum C-terminal telopeptide of type I collagen, abbreviated CTX, from baseline to 20 weeks. The registry reports the endpoint as a median with a full range for each group. CTX is a biomarker used to measure the rate of bone turnover; the registry describes it as useful for assessing bone health and evaluating treatment responses. In general, a biomarker is a measurable biological indicator. A change in a biomarker is not, by itself, a direct measure of a clinical outcome such as a fracture or a participant’s overall health.
The results are presented as percent changes, so the reported medians describe the central observed change within each group rather than a mean change. The full range gives the lowest and highest observed values in the reported group, not the precision of the median. A range can show that individual observed changes varied, but it does not quantify uncertainty in the estimated group median. The registry record does not report a confidence interval for these median changes.
The endpoint is relevant to the trial’s stated interest in bone resorption, but interpreting it requires attention to the comparator, observed variability, and the statistical analysis. CTX alone cannot establish whether the treatment changed senescent-cell burden or other bone outcomes. Nor does a biomarker result, without further evidence, determine the clinical importance of a change.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted median percent change in CTX was -4.1 for dasatinib plus quercetin, 13.7 for fisetin, and -7.7 for untreated control. The registry gives full ranges of -28.1 to 114.6, -42.7 to 61.0, and -42.4 to 22.5, respectively. These summaries describe the observed endpoint values in each group. The ranges are broad, and the range for each treatment group overlaps the range for untreated control. Ranges show the spread of observed values, but they are not confidence intervals and do not provide a direct measure of uncertainty around the medians.
The registry reports a Wilcoxon (Mann-Whitney) test for dasatinib plus quercetin versus untreated control, with p = 0.611. This is the only reported primary-outcome test in the available record. A p-value describes how compatible the observed data are with a specified null model under the assumptions of the test. It is not the probability that the null hypothesis is true, and it does not measure the size or importance of an effect. The registry record does not report a confidence interval or a test result for fisetin versus control.
The posted medians are not identical, but their differences should not be interpreted as established treatment effects solely from the group summaries. The reported test does not indicate a statistically clear difference for its stated comparison, while the record does not provide enough information to assess the precision of the estimated contrast. A non-significant test does not show that groups are equivalent. Establishing equivalence would require a defined equivalence question and suitable analysis, neither of which is reported in the registry record.
Outcome counts also matter when reading the summaries. The CTX results list 28 participants for dasatinib plus quercetin, 11 for fisetin, and 28 for untreated control. The registry does not explain the smaller listed count for fisetin or specify how missing measurements, withdrawals, or exclusions were handled. The observed summaries therefore should not automatically be read as results for everyone enrolled or as an intention-to-treat analysis.
The broader study aim concerned senescent-cell burden and several skeletal-health markers. A single posted primary marker result does not resolve those broader questions. Secondary outcomes are listed, but their full estimates, uncertainty, and analysis details are not available in the registry record in the registry record. Overall, the posted CTX data show varied observed changes and one reported comparison with p = 0.611; they do not by themselves establish the presence, absence, or clinical importance of an effect.
9. Statistical Methods Explained
The primary endpoint is summarized using medians and full ranges. These descriptive statistics answer different questions. A median is the midpoint of ordered observations: half the observations lie at or below it and half at or above it, subject to ties. It is less influenced by extreme observations than a mean. A full range reports the smallest and largest observed values. It displays the span of the data but is sensitive to extreme values and does not indicate how precisely a group contrast has been estimated.
What does the reported rank test compare?
The registry names the Wilcoxon (Mann-Whitney) test for the comparison of dasatinib plus quercetin with untreated control. This is a rank-based method: it uses the ordering of observations rather than relying directly on a comparison of means. In general, rank-based methods can be useful when distributions are skewed or contain extreme values. The test is not automatically a test of medians in every setting. Interpreting it strictly as a median comparison requires assumptions about the shapes of the group distributions, and the registry record does not report distributional diagnostics.
The reported p-value is 0.611. In general, a p-value describes the compatibility of data with a null hypothesis under a chosen statistical model and test procedure. It does not report the probability that a treatment has no effect. A p-value also does not show whether a difference is large enough to matter clinically. For this reason, estimates of contrasts and confidence intervals are useful complements. The registry record does not report a confidence interval for the treatment-control comparison.
Why does variability matter?
The posted full ranges include observations on both sides of the group medians, and the ranges extend widely. In general, substantial variation among participants can make group comparisons less precise. The range alone cannot tell how much uncertainty surrounds a median or treatment contrast: that requires information about the data and an appropriate inferential method. The registry reports no standard deviation or other spread measure for this endpoint, and labels the descriptive summary as a median with full range.
Over-dispersion is a general concern when data vary more than a statistical model expects. A model that understates variability can produce overly narrow uncertainty estimates and tests that are too optimistic. The reported primary comparison is rank-based rather than a model-based count analysis, so over-dispersion is not a specific feature established by the available endpoint information. More generally, a method should match the outcome’s distribution and study design; the registry record does not report diagnostics or details sufficient to assess those choices.
How should a confidence interval be understood?
In general, a confidence interval gives a range of values compatible with the data and a statistical procedure, reflecting uncertainty in an estimate. It is not a range containing a fixed proportion of individual participant outcomes, which is the role of a range or a prediction interval under suitable definitions. No confidence interval is reported for the group medians or the stated primary comparison in the registry record. Consequently, the precision of the estimated contrast cannot be read directly from the posted p-value or the full ranges.
What is known about planning calculations?
The registry’s planning assumptions describe an illustration based on the observed effect, using a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation; the effect to detect is described as a stated fraction of the observed effect. Such calculations are planning illustrations, not observed power and not evidence about the probability that the trial result is correct. Numerical planning estimates are not reported in the registry record available for this analysis. The record also does not report the trial’s own sample-size justification, so the planning assumptions should not be mistaken for the protocol rationale.
In general, sample-size planning depends on the target effect, variability, chosen error rate, allocation, and analysis method. A calculation based on an observed effect is especially sensitive to uncertainty in that effect. If the observed effect is unstable, an illustration based on it may not represent a reliable future target. These general considerations do not show how the trial was planned; the registry record does not report that information.
What does the comparison cover?
The reported test concerns dasatinib plus quercetin versus untreated control. It does not provide a reported inferential comparison for fisetin versus control, nor does it directly compare the two active treatment groups. A test result for one contrast should not be generalized to the other groups or to every endpoint. The registry lists six outcome measures and five secondary outcomes, but the record does not report a complete statistical analysis plan or enough results to assess all outcome comparisons.
10. Analyses Reported by the Sponsor
| Method | Estimate | 95% CI | P-value |
|---|---|---|---|
| Wilcoxon (Mann-Whitney) | not reported | 0.611 |
The registry reports the sponsor’s Wilcoxon (Mann-Whitney) analysis comparing dasatinib plus quercetin with untreated control. Its reported p-value is 0.611. The registry does not report a separate recalculated test result or a confidence interval for that comparison in the information available for this analysis. The arm-level medians and full ranges are descriptive summaries; they are not a replacement for the sponsor’s inferential test.
The reported test should therefore be read as the registry’s stated analysis for that contrast, not as a test of fisetin or of all study outcomes. The record does not specify further details of the test implementation, such as handling of missing measurements or the analysis population. A recalculation from summary statistics, if available, would not reproduce participant-level ranks or adjust for unreported design features. No such separate result is reported in the registry record, so the sponsor’s posted test remains the inferential result available for this comparison.
The p-value does not quantify the treatment-control effect or its precision. Since a confidence interval for the contrast is not reported, the uncertainty around its size cannot be assessed directly from this result. The registry record does not report a discrepancy between a sponsor analysis and a recalculation.
11. Multiplicity, Missing Data and Analysis Populations
The registry lists six outcome measures, including the primary CTX endpoint, and five secondary outcomes. It reports five analyses overall, while the available primary-result information includes one named test: dasatinib plus quercetin versus untreated control. The record does not provide a complete map connecting each analysis to each endpoint and group contrast. It is therefore not possible to determine from the registry information whether every planned comparison was reported.
Multiplicity arises when several hypotheses are tested. In general, as the number of tests increases, the chance of at least one false-positive result can increase if each test is judged separately. Statistical plans may address this through prespecified primary outcomes, testing hierarchies, or adjustments to significance thresholds. The registry record does not report whether any multiplicity adjustment was planned or used, or how the primary and secondary outcomes were prioritized in the analysis.
The registry does not report how missing CTX values were handled, why the group-specific outcome counts differ from enrollment, or whether participants were analyzed according to randomized assignment. The analysis population is not reported in the registry record. It also does not report whether there were interim analyses, how withdrawals were handled, or whether any imputation method was used. These omissions limit assessment of potential bias and the representativeness of the posted summaries.
In general, missing data can affect interpretation when the likelihood of missingness is related to participant characteristics or outcomes. The direction and size of any effect cannot be inferred without information on the missing-data process and analysis. The group counts alone do not establish why observations are absent, and they should not be used to guess the analysis set. These details are not reported in the registry record.
12. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Dasatinib Plus Quercetin Treatment Goup | 0 | 30 | 0.0% |
| Fisetin Treatment Group | 1 | 14 | 7.1% |
| Untreated Control Group | 0 | 30 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Dasatinib Plus Quercetin Treatment Goup | 0 of 30 |
| Fisetin Treatment Group | 0 of 14 |
| Untreated Control Group | 0 of 30 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Dasatinib Plus Quercetin Treatment Goup | 23 of 30 |
| Fisetin Treatment Group | 12 of 14 |
| Untreated Control Group | 5 of 30 |
Most frequent serious adverse event terms
| Event term | Organ system | Dasatinib Plus Quercetin Treatment Goup | Fisetin Treatment Group | Untreated Control Group |
|---|---|---|---|---|
| Gastric hemorrhage | Gastrointestinal disorders | 0 of 30 | 1 of 14 | 0 of 30 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Dasatinib Plus Quercetin Treatment Goup | Fisetin Treatment Group | Untreated Control Group |
|---|---|---|---|---|
| Headache | Nervous system disorders | 16 of 30 | 1 of 14 | 0 of 30 |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 2 of 30 | 5 of 14 | 3 of 30 |
| Diarrhea | Gastrointestinal disorders | 7 of 30 | 1 of 14 | 0 of 30 |
| Nausea | General disorders | 5 of 30 | 1 of 14 | 0 of 30 |
| Fatigue | General disorders | 4 of 30 | 1 of 14 | 0 of 30 |
| Constipation | Gastrointestinal disorders | 3 of 30 | 1 of 14 | 0 of 30 |
| Pain | General disorders | 3 of 30 | 1 of 14 | 0 of 30 |
| Vertigo | Ear and labyrinth disorders | 2 of 30 | 1 of 14 | 1 of 30 |
| Gastroesophageal reflux disease | Gastrointestinal disorders | 2 of 30 | 0 of 14 | 0 of 30 |
| Covid | Respiratory, thoracic and mediastinal disorders | 2 of 30 | 0 of 14 | 0 of 30 |
Serious events with the highest arm-level rate: gastric hemorrhage (7.1%).
The registry reports serious adverse events among 30 participants at risk in the dasatinib-plus-quercetin group, 14 in the fisetin group, and 30 in the untreated control group. Serious adverse events affected 0, 1, and 0 participants, respectively. Deaths were 0 in each group. These are event counts as recorded; they do not establish that an event was caused by an intervention or that the risk is absent when no event was recorded.
The registry lists gastric hemorrhage at 7.1% among the top serious adverse event terms. The available record does not give additional context for interpreting that percentage or attribute the term to a particular group in the information. The registry also reports other adverse events affecting 23 participants at risk of 30 in the dasatinib-plus-quercetin group, 12 at risk of 14 in the fisetin group, and 5 at risk of 30 in the untreated control group. Those figures belong to the registry’s other-adverse-event category and should not be conflated with the serious-event counts.
In general, adverse-event summaries depend on how events were collected, coded, and attributed, and on the observation period. The record does not provide further detail about event definitions, severity classifications for the other-event category, or causal assessment. The group counts are useful for describing what was posted, but they do not alone establish comparative safety.
13. What the Result Does, and Does Not, Mean
The registry records a randomized, open-label, Phase 2 trial with a primary endpoint focused on change in CTX over 20 weeks. The posted medians were -4.1 for dasatinib plus quercetin, 13.7 for fisetin, and -7.7 for untreated control. The reported full ranges show variation within all three groups. For the comparison of dasatinib plus quercetin with untreated control, the registry reports a Wilcoxon (Mann-Whitney) p-value of 0.611.
These findings describe the posted data; they do not establish that the groups are equivalent, nor do they determine the clinical importance of any difference. A p-value is not a measure of effect size, and the registry does not report a confidence interval for the comparison. The available information also does not report a test of fisetin versus control. Accordingly, the stated primary test cannot be used as a conclusion about every treatment or every outcome.
The primary endpoint is a biomarker, not a direct clinical outcome. Although CTX is used to measure bone turnover, its change alone cannot establish an effect on bone mineral density, fractures, overall skeletal health, or senescent-cell burden. The registry lists several related outcomes, but their results and analysis details are not fully represented in the information available for this interpretation.
The outcome counts and missing-data methods are not explained in the registry record. This makes it difficult to know how the posted summaries relate to all enrolled participants. Safety counts are also descriptive and do not, by themselves, establish causation or comparative safety. The study record is therefore best read as a report of observed marker summaries, one named statistical comparison, and adverse-event counts, with important analytical details not reported.
14. Why This Trial Matters Statistically
This trial is statistically informative because it brings together a randomized comparison, an open-label design, a biomarker endpoint, and group summaries based on medians and ranges. Each feature affects interpretation. Randomization supports comparison between assigned groups, but it does not by itself guarantee that every analysis includes all randomized participants or eliminate the need to understand missing data. The registry record does not state the analysis population or the handling of missing measurements.
The choice to summarize CTX using a median and full range makes the distribution of observed values important. A median can describe a typical position without being dominated by extreme observations, while a full range makes the observed span visible. Neither gives the uncertainty around the treatment contrast. The registry reports a rank-based test for one comparison, but does not report a confidence interval for that contrast. This illustrates why a test result and descriptive summaries do not answer every question about magnitude and precision.
The study also lists several outcomes and treatment groups. Without a complete analysis plan and multiplicity information, it is difficult to assess how the primary comparison fits among all outcomes and contrasts. Reporting which tests were planned, how missing data were handled, and what estimates accompany the tests would help readers interpret the evidence.
Finally, the distinction between a biomarker and a clinical outcome is central. CTX can characterize bone turnover, but its change alone does not establish a change in clinical skeletal outcomes. The registry’s stated focus on senescent-cell burden and several bone measures requires interpretation across the relevant outcomes, not from the primary marker alone.
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 registry record leaves several trial-specific uncertainties. It identifies the study as single-center, open-label, randomized, and parallel-group, but does not report details of sequence generation or allocation concealment. It also does not report the trial’s own sample-size justification, the complete statistical analysis plan, or whether interim analyses were conducted. These omissions prevent a full assessment of how design and analysis decisions were specified before outcomes were observed.
The posted CTX outcome counts are 28 for dasatinib plus quercetin, 11 for fisetin, and 28 for untreated control, while enrollment is 74. The record does not explain the differing counts or identify the population used in each analysis. It does not report how missing outcomes, withdrawals, or exclusions were handled. This limits interpretation of how representative the outcome summaries are of the randomized groups.
The primary results provide medians and full ranges, and the reported test provides a p-value for one comparison. A confidence interval for the contrast is not reported. The registry also does not provide a reported test for fisetin versus control in the registry entries. The listed secondary outcomes and number of analyses point to multiple areas of interest, but multiplicity handling and the full correspondence between outcomes and analyses are not reported.
The open-label design is another consideration: the registry records no masking. The treatment descriptions are also truncated in the available record, so they do not support a complete reconstruction of administration details. Finally, the primary endpoint is a biomarker, and the registry information does not establish how it relates to clinical skeletal outcomes. These limitations describe gaps in the record, rather than proof of flaws in the conduct of the trial.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Targeting Cellular Senescence With Senolytics to Improve Skeletal Health in Older Humans — NCT04313634.
- Registry record last updated 2024-07-22; status last verified 2024-07.
- Results first posted 2024-07-22.
- 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.
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19. Record Summary
The registry identifies NCT04313634 as a completed Phase 2, single-center, open-label randomized parallel-group trial, with enrollment of 74. The study compared dasatinib plus quercetin and fisetin with an untreated control group. Its primary endpoint was median percent change in serum CTX from baseline to 20 weeks.
Posted CTX medians were -4.1 for dasatinib plus quercetin, 13.7 for fisetin, and -7.7 for untreated control. The reported Wilcoxon (Mann-Whitney) comparison of dasatinib plus quercetin with control had p = 0.611. The registry also lists secondary outcomes involving bone-turnover markers, bone mineral density, and plasma senescence-associated secretory phenotype.
Serious adverse events affected 0 participants in the dasatinib-plus-quercetin group, 1 in the fisetin group, and 0 in the untreated control group; deaths were 0 in each group. The registry record does not report key details including the analysis population, missing-data handling, multiplicity procedures, or a confidence interval for the primary comparison.