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 A Study to Assess Immune Response in Pediatric Kidney Transplant Recipients Treated With Daclizumab (Zenapax) (NCT02576145), a non-randomized phase 4 study. The primary outcome is Number of Participants Who Developed a Positive Antibody Response (IgG) to Keyhole Limpet Hemocyanin (KLH) Immunization.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02576145 |
| Phase | Phase 4 |
| Condition | Kidney Transplantation |
| Allocation | Non-Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 11 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Hoffmann-La Roche |
| Results posted | Yes |
2. Clinical Question
Population
Children who received a kidney transplant and were enrolled in the study. The primary endpoint population was restricted to participants who received at least two vaccine doses and had Day 43 and Day 57 assessments.
Intervention
Group A participants were receiving a full course of five daclizumab doses at 1 milligram per kilogram. The Day 1 vaccine was administered immediately before the fifth dose. The study assessed immune responses after vaccination, including response to keyhole limpet hemocyanin (KLH).
Comparator
Group B participants had completed a full course of daclizumab therapy in the previous 4 to 18 months. This was a non-randomized comparison, not a like-for-like control comparison. Participants were therefore in different treatment-timing groups, and the registry record does not establish that the groups were otherwise comparable.
Primary question
How many participants developed a positive IgG antibody response to KLH immunization, defined as at least a 2-fold increase in antibody concentration on Day 43 or Day 57 compared with baseline, with a below-quantification baseline assigned a value of 1?
The broader question was whether children receiving a kidney transplant could mount a primary immune response during daclizumab treatment. Secondary outcomes covered cellular and antibody responses to KLH and tetanus toxoid, responses after rechallenge among some initial nonresponders, and geometric mean antibody concentrations. These measures address different aspects of immune response and should not be treated as interchangeable.
The registry record reports enrollment of 11 participants and describes a target sample size of 82 individuals in the study summary. It does not report the numerical result for the primary question. Consequently, the clinical question can be described from the endpoint definition and group descriptions, but the record does not show how many participants met the primary response definition in either group.
3. Trial Design
This was a Phase 4, completed, parallel-group study with non-randomized allocation and no masking. It concerned kidney transplantation and immune responses in pediatric recipients treated with daclizumab. The registry record gives enrollment as 11. Its study summary states a target sample size of 82 individuals, so the stated target and recorded enrollment are not the same. The reason for the difference is not reported in the registry record.
Group A included participants receiving a full course of five daclizumab doses at 1 milligram per kilogram, with the Day 1 vaccine administered immediately before the fifth dose. Group B included participants who had completed a full course of daclizumab therapy in the previous 4 to 18 months. These groups represent different treatment timing, rather than a randomized comparison of otherwise comparable participants. Differences in immune responses between them, if reported, could not be attributed to treatment timing alone from this design.
The study was listed as starting in 2003-04, with primary completion in 2006-01, and its status is completed. The registry lists DT, daclizumab, and KLH as interventions. The available arm descriptions clarify daclizumab timing and refer to vaccination, while the primary endpoint specifically concerns KLH immunization.
The primary endpoint timeframe was baseline and Day 43 or Day 57. The primary analysis population was defined as enrolled participants who received at least two vaccine doses and had assessments at Day 43 and Day 57. The registry record does not report a statistical analysis plan, the allocation procedure beyond non-randomization, or a sample-size justification. Such details should not be inferred from the endpoint description or the listed target enrollment.
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 | Group A (With Daclizumab Therapy) | Group B (Post Daclizumab Therapy) |
|---|---|---|
| STARTED | 6 | 5 |
| COMPLETED | 3 | 4 |
| NOT COMPLETED | 3 | 1 |
Reasons for not completing this period:
| Reason | Group A (With Daclizumab Therapy) | Group B (Post Daclizumab Therapy) |
|---|---|---|
| Adverse Event | 1 | 0 |
| Withdrawal by Subject | 1 | 0 |
| Acute rejection | 1 | 0 |
| Tetanus Titers Decreased | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: All patient population: All participants who were enrolled in the study and received at least 2 vaccine doses and had Day 43 and 57 assessments were included in this population.
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 | Group A (With Daclizumab Therapy) | Group B (Post Daclizumab Therapy) | Total |
|---|---|---|---|---|
| Participants analysed | 6 | 5 | 11 | |
| Age, Continuous | years | 11.8 (SD 5.78) | 12.6 (SD 4.16) | 12.2 (SD 4.87) |
| Sex: Female, Male: Female | Participants | 2 | 2 | 4 |
| Sex: Female, Male: Male | Participants | 4 | 3 | 7 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants Who Developed a Positive Antibody Response (IgG) to Keyhole Limpet Hemocyanin (KLH) Immunization, measured over Baseline and Day 43 or Day 57.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint was the number of participants who developed a positive IgG antibody response to KLH immunization. A positive response was defined as an antibody concentration at least 2-fold higher on Day 43 or Day 57 than at baseline. If the baseline concentration was below the limit of quantification, baseline was assigned a value of 1. Humoral responses were assessed by enzyme-linked immunosorbent assay (ELISA).
This endpoint turns a laboratory measurement into a participant-level responder classification. It can be useful when the question is whether participants crossed a prespecified response threshold, rather than how antibody concentrations vary across their full range. The registry record’s definition makes the threshold and assessment times explicit, but it does not report the numbers of responders or nonresponders.
General statistical context: a binary endpoint such as responder status is commonly expressed as a count or proportion within a group. The count alone describes how many participants met the rule; a comparison between groups also needs a clearly defined contrast and an assessment of uncertainty. Because the record gives no primary outcome counts, effect estimate, or confidence interval, the size and precision of any group contrast cannot be evaluated from the registry record.
The endpoint is specific to IgG antibody response to KLH. It does not by itself summarize the cellular responses, responses to tetanus toxoid, or geometric mean antibody concentrations listed among the secondary outcomes. Those outcomes capture distinct measurements and would need their own results and definitions for interpretation.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes the primary outcome definition and follow-up assessments, but it does not report a numerical primary result. It therefore does not establish how many participants developed a positive IgG response to KLH in either group, nor does it provide an estimate of the difference between groups. A direction, magnitude, or precision of effect cannot be inferred from the endpoint definition, enrollment, or study status.
The record lists 11 participants enrolled. The group denominators in the serious adverse event summary are 6 for Group A and 5 for Group B, but those are safety denominators and should not automatically be substituted for the endpoint population. The primary population required receipt of at least two vaccine doses and Day 43 and Day 57 assessments. Its group-specific numbers are not reported in the registry record.
The comparison also requires caution because allocation was non-randomized. Group A was receiving daclizumab at the time of vaccination, whereas Group B had completed treatment in the previous 4 to 18 months. A difference between these groups, even if numerical results were available, could reflect differences between the participants or their treatment circumstances as well as treatment timing. The registry record does not report enough information to separate these possibilities.
General statistical context: an estimate describes the observed contrast, while a confidence interval describes the range of values reasonably compatible with the data under the analysis assumptions. A narrow interval indicates greater precision than a wide interval, but neither alone resolves bias from non-randomized allocation. No effect estimate or confidence interval for the primary endpoint is reported in the registry record.
The study summary describes a target sample size of 82 individuals, while recorded enrollment is 11. These figures describe planning and enrollment, not the number of primary endpoint responders. The registry record does not explain the difference or report a sample-size justification. It also lists zero analyses, and no primary outcome result is available to support a conclusion about the observed immune response. This is absence of a reportable result in the registry record, not evidence that the response was absent.
9. Statistical Methods Explained
Statistical interpretation begins with the endpoint definition, the analysis population, and the form of the comparison. In this study, the primary outcome is a participant count: each eligible participant is classified according to whether an IgG antibody response to KLH crossed the stated threshold at Day 43 or Day 57. The primary population also has assessment and vaccination requirements. These details determine which participants can contribute to the endpoint; the enrolled population and the endpoint population need not be identical.
What does a responder count tell the reader?
A count states how many participants met a binary rule. It does not show the distribution of antibody concentrations among responders, how far above the threshold they were, or how close nonresponders came to it. A responder definition can make a result easier to interpret, but the conclusion remains tied to the chosen threshold, assay, baseline handling, and assessment times. Here, the record defines a positive response as at least a 2-fold increase on Day 43 or Day 57, and assigns a value of 1 when baseline is below the limit of quantification.
General statistical context: binary outcomes may be described using counts, proportions, or contrasts between groups. A group contrast can be expressed in different ways, and each measure answers a somewhat different question. Any such estimate should be read alongside its uncertainty and the population included in the analysis. The registry record does not report endpoint counts or a contrast for this primary outcome, so no such estimate can be interpreted from the record.
Why does allocation matter?
Random allocation is designed to make treatment groups comparable, on average, with respect to measured and unmeasured characteristics. This study is explicitly non-randomized. Its groups also differ in treatment timing: one was receiving daclizumab when vaccinated, and the other had completed a course in the previous 4 to 18 months. As a result, a simple group comparison would be observational. Possible differences in participant characteristics or care circumstances could be related to both group membership and immune response. The record does not report an adjustment strategy, so it is not possible to say whether or how such factors were addressed.
General statistical context: adjustment can account for measured characteristics if they are recorded and appropriately modeled, but it cannot guarantee removal of all confounding. A statistical adjustment plan is not reported in the registry record. Non-randomized comparisons therefore require more cautious causal interpretation than randomized comparisons, even when an outcome difference is observed.
How should precision be assessed?
General statistical context: a confidence interval accompanies an estimate to show its statistical uncertainty. For a binary endpoint, precision depends in part on the amount of outcome information available. A small study can yield imprecise estimates, although the degree of uncertainty must be judged from the actual counts and interval rather than enrollment alone. No primary estimate or confidence interval is reported in the registry record, so the precision of the primary endpoint is not reported in the registry record.
The registry record reports 11 enrolled participants, and the study summary gives a target of 82 individuals. The reason that enrollment differs from the stated target is not reported in the registry record. A target or a planning illustration cannot replace observed outcome data. The sample-size assumptions describe a planning 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. They specify that the effect to detect is a stated fraction of the observed effect. The resulting sample sizes are planning illustrations, not observed power. Since the primary effect estimate is not reported in the registry record, those assumptions do not supply evidence about the actual response result.
What is the role of secondary outcomes?
Secondary outcomes include cellular response to KLH, combined antibody and cellular responses, humoral and cellular responses to tetanus toxoid, cellular responses after rechallenge among nonresponders, and geometric mean antibody concentrations for KLH and tetanus toxoid. These endpoints measure different features of immune response. A cellular response is not the same outcome as an antibody response, and a combined responder definition is not interchangeable with either component alone. The record lists these outcomes but does not report their numerical results. No result should be inferred from an outcome’s presence in the registry.
General statistical context: when a study assesses multiple outcomes, interpreting isolated findings can raise multiplicity concerns. Different outcomes may also have different analysis populations and missingness. Whether any adjustment for multiple testing was intended or applied, and how missing data were handled, are not reported in the registry record. Those omissions limit assessment of the analysis strategy, but they do not justify assuming that a particular method was or was not used.
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.
| Arm | Participants | Events | Observed % | Clopper-Pearson 95% CI | Wilson 95% CI | Bayesian 95% credible interval |
|---|---|---|---|---|---|---|
| Group A (With Daclizumab Therapy) | 5 | 2 | 40.0% | 5.3% to 85.3% | 11.8% to 76.9% | 11.8% to 77.7% |
| Group B (Post Daclizumab Therapy) | 5 | 2 | 40.0% | 5.3% to 85.3% | 11.8% to 76.9% | 11.8% to 77.7% |
R code and output
arm <- c("Group A (With Daclizumab Therapy)", "Group B (Post Daclizumab Therapy)")
n <- c(5, 5)
events <- c(2, 2)
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 Group A (With Daclizumab Therapy) 5 2 40.0 5.3 85.3 11.8 76.9 11.8 77.7
ARM Group B (Post Daclizumab Therapy) 5 2 40.0 5.3 85.3 11.8 76.9 11.8 77.711. Multiplicity, Missing Data and Analysis Populations
The registry record lists 16 outcome measures, including the primary IgG response to KLH and secondary measures covering cellular responses, combined response definitions, tetanus toxoid responses, rechallenge outcomes, and geometric mean antibody concentrations. Assessing multiple outcomes can increase the chance that some findings appear noteworthy by chance when each is examined separately. General statistical context: multiplicity procedures can be used to control or describe this issue, but the choice depends on the analysis plan and the role assigned to each outcome.
Whether multiplicity was addressed, which outcomes were considered confirmatory, and whether any hierarchy or adjustment was used are not reported in the registry record. No numerical results for the listed outcomes are reported there either. The count of outcome measures alone does not establish that all were tested in the same way or that any particular correction was applied.
The primary analysis population included enrolled participants who received at least two vaccine doses and had Day 43 and Day 57 assessments. This definition clarifies eligibility for the endpoint analysis, but the registry record does not report the number meeting these criteria or how missing assessments were handled. It also does not report whether participants with incomplete measurements were excluded, imputed, or addressed using another method. Missing-data assumptions can affect interpretation when availability of an assessment is related to participant characteristics or response, so these details matter.
The record lists zero analyses. It does not report an analysis plan, endpoint-specific analysis populations, or handling of missing outcome data. The absence of those details means the analysis process cannot be reconstructed from the registry record; it is not evidence that a specific missing-data or multiplicity method was used.
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 |
|---|---|---|---|
| Group A (With Daclizumab Therapy) | 3 | 6 | 50.0% |
| Group B (Post Daclizumab Therapy) | 2 | 5 | 40.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Group A (With Daclizumab Therapy) | 6 of 6 |
| Group B (Post Daclizumab Therapy) | 4 of 5 |
Most frequent serious adverse event terms
| Event term | Organ system | Group A (With Daclizumab Therapy) | Group B (Post Daclizumab Therapy) |
|---|---|---|---|
| BK virus infection | Infections and infestations | 1 of 6 | 0 of 5 |
| Epstein-Barr virus infection | Infections and infestations | 1 of 6 | 0 of 5 |
| Gastroenteritis | Infections and infestations | 0 of 6 | 1 of 5 |
| Viral infection | Infections and infestations | 0 of 6 | 1 of 5 |
| Haematuria | Renal and urinary disorders | 1 of 6 | 0 of 5 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Group A (With Daclizumab Therapy) | Group B (Post Daclizumab Therapy) |
|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | 3 of 6 | 0 of 5 |
| Vomiting | Gastrointestinal disorders | 1 of 6 | 1 of 5 |
| Haematuria | Renal and urinary disorders | 2 of 6 | 0 of 5 |
| Blood creatinine increased | Investigations | 1 of 6 | 1 of 5 |
| Hordeolum | Infections and infestations | 1 of 6 | 0 of 5 |
| Upper respiratory tract Infection | Infections and infestations | 0 of 6 | 1 of 5 |
| Bronchitis | Infections and infestations | 1 of 6 | 0 of 5 |
| Gastroenteritis | Infections and infestations | 1 of 6 | 0 of 5 |
| Pneumonia | Infections and infestations | 0 of 6 | 1 of 5 |
| Rhinitis | Infections and infestations | 0 of 6 | 1 of 5 |
Serious events with the highest arm-level rate: gastroenteritis (20.0%), viral infection (20.0%), bk virus infection (16.7%), epstein-barr virus infection (16.7%), haematuria (16.7%).
The serious adverse event summary gives Group A as 3 participants affected among 6 at risk and Group B as 2 among 5 at risk. The registry also lists gastroenteritis and viral infection at 20.0% each, and BK virus infection, Epstein-Barr virus infection, and haematuria at 16.7% each, as the top serious terms.
These figures describe serious adverse events recorded in the registry; they do not by themselves establish that an event was caused by daclizumab, vaccination, or the study. The listed terms are not accompanied by group-specific counts in the available record, so they should not be assigned to either group from these percentages. The registry record does not report deaths.
General statistical context: in small groups, each participant represents a substantial part of the denominator, so event counts and denominators are essential for interpretation. The risk groups are small, and these descriptive figures do not provide a precise estimate of comparative safety. The registry record does not report a formal safety comparison or uncertainty estimates. Serious adverse event summaries should therefore be read as descriptions of recorded events, not as proof of a treatment effect or as a complete account of all possible safety outcomes.
13. What the Result Does, and Does Not, Mean
The record establishes that the study assessed immune responses in pediatric kidney transplant recipients across two daclizumab treatment-timing groups. It defines a primary IgG antibody response to KLH using a threshold and assessment times, and it lists additional outcomes involving cellular responses, tetanus toxoid, rechallenge, and antibody concentrations. It also reports enrollment of 11 participants and describes a target sample size of 82 individuals.
What the record does not establish is the number of participants who met the primary response definition, the size or direction of any difference between groups, or the precision of a comparison. The primary numerical result is not reported in the registry record. The record also does not report numerical results for the listed secondary outcomes. Without those findings, it is not possible to describe the observed immune response or determine whether groups differed on the measured outcomes.
The non-randomized design further limits interpretation of any between-group difference. Group membership corresponds to different daclizumab timing, and no basis for treating the groups as exchangeable is reported. Even if outcome estimates were available, an association between group and response would not by itself establish that treatment timing caused the difference.
General statistical context: a study result is most informative when the endpoint, analysis population, estimate, and uncertainty are all available. A registry endpoint definition is not a substitute for a result, and a target sample size is not evidence that a particular effect was observed. Likewise, a lack of a reported numerical result should not be interpreted as a zero response, no difference, or evidence against an effect. It means the registry record does not contain the outcome data needed to draw those conclusions.
The safety summary records serious adverse events in both groups and lists several serious event terms. Those descriptive figures do not establish causation or allow a precise safety comparison. Overall, the record supports a description of the study question, design, endpoint definitions, and limited safety counts, but not a quantitative conclusion about the primary immune-response outcome.
14. Why This Trial Matters Statistically
This study illustrates why a registry entry needs to be read at several levels. The endpoint definition specifies what counted as a positive KLH antibody response, but a definition alone does not tell the reader what participants experienced. The numerical outcome, analysis population, and uncertainty are needed to judge the observed response. In this record, the primary numerical result is not reported.
The design is also central to interpretation. The study compares participants receiving daclizumab at vaccination with participants who completed a course in the previous 4 to 18 months. Because allocation was non-randomized, the groups are not a like-for-like control comparison. This distinction matters when moving from a descriptive association to a causal claim. A statistical contrast cannot, on its own, correct for unmeasured differences between groups.
The gap between the target sample size of 82 individuals and the enrollment of 11 also emphasizes that planned and observed enrollment are different concepts. The registry record does not explain that gap or report the sample-size justification. Planning illustrations, even when they are based on a specified effect assumption, do not describe observed power or replace outcome results.
Finally, the multiple immune outcomes show that “immune response” is not a single measurement. Antibody response, cellular response, combined definitions, and geometric mean concentrations address distinct questions. Readers need outcome-specific results and clarity about multiplicity and missing data to understand a study’s evidential contribution. Those details are not reported in the registry record. The statistical importance of this study lies in these interpretation constraints as much as in the stated research question.
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 most consequential limitation for interpreting this record is that numerical primary and secondary outcome results are not reported in the registry record. The endpoint definition is detailed, but there are no response counts, group contrasts, confidence intervals, or p-values to assess. The record lists zero analyses, and the reason no results are present is not reported in the registry record.
The non-randomized allocation limits any causal comparison between the groups. One group received vaccination while receiving daclizumab, whereas the other had completed treatment in the previous 4 to 18 months. The registry record does not report group comparability, covariate adjustment, or a strategy for addressing confounding. Group-specific efficacy outcome denominators are also not reported; safety denominators should not be assumed to be the analysis population.
The study summary states a target sample size of 82 individuals, while enrollment is 11. The reason for this difference and the sample-size justification are not reported in the registry record. The primary analysis population required at least two vaccine doses and Day 43 and Day 57 assessments, but the number meeting these criteria and the handling of missing assessments are not reported. These omissions make it difficult to assess selection into the analysis population.
The record lists multiple outcomes but does not report whether multiplicity was addressed or which outcomes were treated as primary for inference beyond the stated primary endpoint. The serious adverse event figures are descriptive, with no formal comparison or uncertainty estimates reported. The record also does not report deaths. Taken together, these limitations prevent a reliable assessment of the magnitude, precision, and causal interpretation of immune-response findings from the registry record alone.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: A Study to Assess Immune Response in Pediatric Kidney Transplant Recipients Treated With Daclizumab (Zenapax) — NCT02576145.
- Registry record last updated 2016-01-13; status last verified 2015-12.
- Results first posted 2016-01-13.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
19. Record Summary
NCT02576145 is a completed Phase 4, parallel-group, non-randomized, unmasked study of immune response in pediatric kidney transplant recipients treated with daclizumab. Enrollment was 11. The record describes Group A as receiving a full course of five daclizumab doses at 1 milligram per kilogram, with Day 1 vaccine immediately before the fifth dose; Group B completed a full course in the previous 4 to 18 months.
The primary outcome was the number of participants with a positive IgG antibody response to KLH, defined as at least a 2-fold increase on Day 43 or Day 57 compared with baseline, with a below-quantification baseline assigned a value of 1. The primary numerical result and results for the listed secondary outcomes are not reported in the registry record.
The serious adverse event summary lists 3 of 6 participants affected in Group A and 2 of 5 in Group B, along with several event terms. These figures are descriptive and do not establish causation. The study summary gives a target sample size of 82 individuals; the reason for the difference from recorded enrollment is not reported in the registry record.