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 Donor Umbilical Cord Blood Transplant After Fludarabine Phosphate, Cyclophosphamide, and Total-Body Irradiation in Treating Patients With High-Risk Hematologic Cancer (NCT00963872), a randomized phase 1, phase 2 study. The primary outcome is Number of Patients With the Complement 3a (C3a) Unit Predominating.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00963872 |
| Phase | Phase 1, Phase 2 |
| Condition | Leukemia, Lymphoma, Multiple Myeloma |
| Allocation | Randomized |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 31 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Masonic Cancer Center, University of Minnesota |
| Results posted | Yes |
2. Clinical Question
Population
People with high-risk hematologic malignancies were the intended population. The listed conditions include leukemia, lymphoma, multiple myeloma, and myelodysplastic syndromes. The registry describes an unrelated donor double umbilical cord blood transplant using a nonmyeloablative preparative regimen. The reported enrollment is 31. The primary-outcome description notes two participants who were unevaluable: one because a cord blood bag broke, leaving one cord available, and one because the participant did not receive C3a.
Intervention
The intervention involved priming one of two umbilical cord blood units with complement fragment 3a (C3a), alongside fludarabine phosphate, cyclophosphamide, and total-body irradiation. The registry describes a phase I part focused on safety and a phase II part studying whether C3a priming facilitates engraftment of the treated unit. The listed intervention descriptions also distinguish C3a priming of the smaller-cell-dose unit from priming of the larger-cell-dose unit.
Comparator
The listed arms are the C3a-primed smaller-cell-dose unit group and the C3a-primed larger-cell-dose unit group. The registry labels allocation as randomized, while also classifying the model as single group. It does not describe a no-C3a or standard-treatment comparison arm. The posted outcome counts therefore describe the listed C3a groups; the record does not provide an estimable two-arm comparison for the binary primary endpoint.
Primary question
The primary endpoint asks how many participants had the C3a unit predominate by day 180. This is a measure of which cord blood unit became the dominant source of blood cells, rather than a direct measure of survival, relapse, or overall clinical benefit. The posted counts are 9 participants in the smaller-cell-dose group, with 24 participants in that arm, and 5 participants in the larger-cell-dose group, with 5 participants in that arm. The registry does not post an estimable statistical comparison between these counts.
3. Trial Design
The registry describes NCT00963872 as a phase I/II study of unrelated donor umbilical cord blood transplantation in patients with hematologic malignancies. Its official title identifies a nonmyeloablative preparative regimen and priming with complement 3a fragment (C3a). The listed regimen includes fludarabine phosphate, cyclophosphamide, and total-body irradiation, followed by a double umbilical cord blood transplant.
The study description separates two aims. The phase I portion studied safety after the transplant regimen. The phase II portion studied whether priming one of the two cord blood units with C3a facilitates engraftment of the treated unit. The primary outcome is the number of participants with the C3a unit predominating at day 180. Secondary outcomes include neutrophil engraftment, donor chimerism in blood and bone marrow, graft-versus-host disease, non-relapse mortality, overall survival, and relapse.
The registry labels the allocation randomized and masking as none, but classifies the study model as single group. It lists two C3a-primed groups distinguished by whether the treated unit had the smaller or larger cell dose. The record does not describe the randomization procedure, how participants were assigned to these groups, or a separate untreated or standard-treatment arm. Those design details are not reported in the registry record.
Enrollment is listed as 31. The record gives a start date of 2010-03, primary completion of 2012-08, and status as terminated. The reason for termination is not reported in the registry record. The posted primary outcome includes arm counts, but no analyses are listed for a two-arm comparison.
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: Subjects that were eligible for umbilical cord transplant were considered for the study.
Overall Study
| Stage | Complement Fragment 3A - Small Cell Dose | Complement Fragment A - Larger Cell Dose |
|---|---|---|
| STARTED | 25 | 6 |
| COMPLETED | 24 | 5 |
| NOT COMPLETED | 1 | 1 |
Analysis population for the primary outcome, as defined in the registry: Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.
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: Two patients were unevaluable because 1 bag broke so only 1 cord was available. One subject never received the C3a.
| Characteristic | Unit | Complement Fragment 3A - Small Cell Dose | Complement Fragment A - Larger Cell Dose | Total |
|---|---|---|---|---|
| Participants analysed | 25 | 6 | 31 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 19 | 5 | 24 |
| Age, Categorical: >=65 years | Participants | 6 | 1 | 7 |
| Age, Continuous | years | 55 (SD 13.0) | 50 (SD 15.7) | 54 (SD 13.4) |
| Sex: Female, Male: Female | Participants | 9 | 2 | 11 |
| Sex: Female, Male: Male | Participants | 16 | 4 | 20 |
| Region of Enrollment: United States | participants | 25 | 6 | 31 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Patients With the Complement 3a (C3a) Unit Predominating, measured over Day 180.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants whose C3a-primed umbilical cord blood unit predominated by day 180. In a double cord blood transplant, this outcome describes which donor unit became the dominant source of blood-cell production. The registry’s stated objective is to assess the efficacy of pre-incubating one of the two cord blood units with C3a as part of the transplant approach.
This endpoint is useful for studying engraftment because it directly addresses whether the treated unit becomes dominant. It is not the same as measuring whether a participant survives, avoids relapse, or has no transplant complications. Those outcomes are listed separately among the secondary outcomes, including overall survival, relapse, non-relapse mortality, and graft-versus-host disease.
The registry reports the endpoint at day 180 as a count. The smaller-cell-dose arm has 9 participants recorded with the C3a unit predominating, among 24 participants in that arm. The larger-cell-dose arm has 5 such participants, among 5 participants in that arm. The primary-outcome description also identifies two unevaluable participants and gives a reason for each. The record does not report a statistical estimate with uncertainty for a comparison between the arms.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
At day 180, the posted primary-outcome counts are 9 participants with C3a-unit predominance in the smaller-cell-dose arm and 5 in the larger-cell-dose arm. The corresponding arm denominators are 24 and 5. These are descriptive counts. They do not, by themselves, establish whether the difference between groups is compatible with chance or reflects a reproducible difference. The registry record does not provide an estimable two-arm comparison for this binary endpoint, and no analyses are listed.
The group sizes are unequal, with a substantially smaller listed denominator in the larger-cell-dose arm. Counts from groups of different sizes should not be compared as if they represented equally sized samples. The registry does not post a comparison estimate or confidence interval to quantify the uncertainty around a between-group contrast. A confidence interval, in general, describes a range of values compatible with the data and the statistical method; without a reported interval or a valid recalculation, the precision of a contrast cannot be characterized from the counts alone.
The primary endpoint concerns which cord unit predominated, not the full set of outcomes relevant to transplant. The registry lists secondary outcomes that include engraftment, chimerism, graft-versus-host disease, non-relapse mortality, overall survival, and relapse. Nineteen secondary outcomes are posted, but the record lists no analyses. The primary count therefore cannot stand in for results on these other outcomes.
The record notes two participants as unevaluable for the primary endpoint, one because a cord blood bag broke and one because C3a was not received. This information helps explain that the primary endpoint was not evaluable for those participants. The record does not describe a broader missing-data method, an analysis population beyond the endpoint description, or how unevaluable participants were treated in any inferential analysis.
The safety data are also descriptive. The registry lists serious adverse events affecting 21 participants in the smaller-cell-dose group and 5 in the larger-cell-dose group, and lists other adverse events affecting 24 and 5 participants, respectively. Those counts should be read alongside the arm denominators and the registry’s listed event terms; they are not evidence of a causal difference between groups. No adjusted estimates, uncertainty intervals, or statistical comparisons for safety are listed.
Overall, the record provides counts for the day 180 endpoint and safety event fields, but not a statistical analysis establishing a difference between groups. The result supports a description of the posted observations only. It does not supply a precise comparative estimate or establish broader clinical effects.
9. Statistical Methods Explained
The primary endpoint is binary at the participant level: the C3a-treated unit either is or is not recorded as predominating by day 180. The posted outcome is expressed as a number of participants with the event, rather than a continuous measurement such as a laboratory value. The registry provides the counts and arm denominators, but no inferential analysis for a two-arm comparison.
For a binary endpoint, common statistical approaches compare the proportion with the event between groups or model the event probability. Such methods can produce an estimate of the group contrast and an uncertainty interval. The choice of method depends on the study design, sample sizes, outcome definition, and analysis plan. In this record, values for a two-arm comparison are described as missing or not estimable, and the number of listed analyses is zero. It would therefore be inappropriate to present an unreported test result as if it came from the registry’s analysis.
A confidence interval is a statistical range that reflects uncertainty in an estimate under a specified method and assumptions. It is useful because a point estimate alone does not indicate how precisely the data locate the underlying effect. The record does not provide a confidence interval for the primary endpoint comparison. The arm counts can be described, but they do not supply the interval or resolve uncertainty about a comparative effect.
The registry’s sample-size assumptions describe planning illustrations based on the observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. The illustration considers detecting a stated fraction of the observed effect. These are planning calculations, not evidence that the study was designed or conducted with those assumptions. They are not observed power, and they do not establish the trial’s original sample-size justification. That justification is not reported in the registry record.
In general, a planning sample size depends on the effect a study aims to detect, the chosen significance level, desired power, allocation, and the statistical method. A sample-size illustration based on an observed effect answers a hypothetical planning question: how many participants per arm would be needed under stated assumptions to detect an effect of a specified size. It does not change the amount of information actually collected, nor does it demonstrate that an observed result is reliable. The registry record does not report the original target enrollment rationale or a prospective sample-size calculation.
The trial is labeled randomized, but the study model is listed as single group and the outcome groups are distinguished by cell dose. In general, random allocation can help balance measured and unmeasured factors across groups, while an analysis must still reflect the allocation and trial structure. The randomization procedure and details of how the two listed groups relate to that allocation are not reported in the registry record. This limits the ability to assess the intended comparison from the posted record alone.
Multiplicity refers to the increased chance of finding apparently noteworthy results when many outcomes or comparisons are analyzed. The registry lists 19 secondary outcomes in addition to the primary endpoint, but no analysis results. It does not report a multiplicity adjustment or an analysis hierarchy for secondary outcomes. In general, the interpretation of multiple tests depends on which outcomes were prespecified, how tests were prioritized, and whether adjustments were planned. Those details are not reported in the registry record.
Over-dispersion is a general concern when observed variation exceeds what a statistical model assumes. It can make model-based uncertainty estimates too small if ignored. The primary outcome is a participant count, and the registry does not report a model or an analysis of the binary endpoint. There is therefore no posted evidence of a particular model assumption or an over-dispersion assessment to interpret.
Safety outcomes also require careful methods. Counts of affected participants summarize whether events were recorded in each group; event-term percentages identify frequently listed serious adverse event terms. These summaries do not establish that an intervention caused an event or that event risks differed between arms. Such conclusions require definitions, observation periods, appropriate comparisons, and uncertainty estimates. The registry does not report a comparative safety analysis or the methods used to handle recurrent events.
In short, the available statistical information is descriptive. The record supplies endpoint counts, denominators, safety counts, and a note that a two-arm binary comparison is not estimable in the posted results. A confidence interval, p value, adjusted effect estimate, and detailed analysis method are not reported in the registry record.
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 |
|---|---|---|---|---|---|---|
| Complement Fragment 3A - Small Cell Dose | 24 | 9 | 37.5% | 18.8% to 59.4% | 21.2% to 57.3% | 21.1% to 57.5% |
| Complement Fragment A - Larger Cell Dose | 5 | 5 | 100.0% | 47.8% to 100.0% | 56.6% to 100.0% | 54.1% to 99.6% |
R code and output
arm <- c("Complement Fragment 3A - Small Cell Dose", "Complement Fragment A - Larger Cell Dose")
n <- c(24, 5)
events <- c(9, 5)
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 Complement Fragment 3A - Small Cell Dose 24 9 37.5 18.8 59.4 21.2 57.3 21.1 57.5
ARM Complement Fragment A - Larger Cell Dose 5 5 100.0 47.8 100.0 56.6 100.0 54.1 99.611. Multiplicity, Missing Data and Analysis Populations
The registry lists 20 outcome measures overall, including the primary endpoint and 19 secondary outcomes. The secondary outcomes span engraftment, donor chimerism, graft-versus-host disease, non-relapse mortality, survival, and relapse. No analyses are listed. A multiplicity adjustment, a hierarchy for testing outcomes, or a description of which secondary outcomes were confirmatory is not reported in the registry record.
Multiplicity matters in general because examining many outcomes can increase the chance that some results appear notable by chance alone. The appropriate interpretation depends on the prespecified analysis plan and whether outcomes were intended to be exploratory or confirmatory. Those details are not reported in the registry record, so no claim about control of multiple testing can be made.
The primary-outcome description identifies two unevaluable participants. One was unevaluable after a cord blood bag broke, leaving one cord available; the other did not receive C3a. The record does not explain a general missing-data strategy, provide a flow of participants for every outcome, or specify how unevaluable observations were handled in an inferential analysis.
The record also does not describe an intention-to-treat population, a per-protocol population, or another formal analysis population. The posted primary endpoint is accompanied by arm counts and denominators, but no analysis results are listed. The extent to which these outcome counts correspond to a prespecified population is 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 |
|---|---|---|---|
| Complement Fragment 3A - Small Cell Dose | 21 | 24 | 87.5% |
| Complement Fragment A - Larger Cell Dose | 5 | 5 | 100.0% |
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 |
|---|---|
| Complement Fragment 3A - Small Cell Dose | 24 of 24 |
| Complement Fragment A - Larger Cell Dose | 5 of 5 |
Most frequent serious adverse event terms
| Event term | Organ system | Complement Fragment 3A - Small Cell Dose | Complement Fragment A - Larger Cell Dose |
|---|---|---|---|
| Blood and lymphatic disorders- Other | Blood and lymphatic system disorders | 10 of 24 | 0 of 5 |
| Fever | General disorders | 5 of 24 | 0 of 5 |
| Adult respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | 1 of 24 | 2 of 5 |
| Death NOS | General disorders | 2 of 24 | 0 of 5 |
| Lung infection | Infections and infestations | 1 of 24 | 1 of 5 |
| Seizure | Nervous system disorders | 2 of 24 | 0 of 5 |
| Confusion | Psychiatric disorders | 2 of 24 | 0 of 5 |
| Leukocytosis | Blood and lymphatic system disorders | 1 of 24 | 0 of 5 |
| Diarrhea | Gastrointestinal disorders | 1 of 24 | 0 of 5 |
| Nausea | Gastrointestinal disorders | 1 of 24 | 0 of 5 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Complement Fragment 3A - Small Cell Dose | Complement Fragment A - Larger Cell Dose |
|---|---|---|---|
| Hypertension | Blood and lymphatic system disorders | 24 of 24 | 4 of 5 |
| Sinus bradycardia | Cardiac disorders | 7 of 24 | 2 of 5 |
| Neurologic disorder | Nervous system disorders | 4 of 24 | 1 of 5 |
| Rash | Skin and subcutaneous tissue disorders | 3 of 24 | 0 of 5 |
| Sinus tachycardia | Cardiac disorders | 2 of 24 | 1 of 5 |
Serious events with the highest arm-level rate: blood and lymphatic disorders- other (41.7%), adult respiratory distress syndrome (40.0%), fever (20.8%), infusion related reaction (20.0%), lung infection (20.0%).
The registry lists serious adverse events for the two C3a-primed groups. In the smaller-cell-dose group, 21 participants are listed as affected among 24 at risk. In the larger-cell-dose group, 5 are listed as affected among 5 at risk. For other adverse events, the corresponding affected counts are 24 among 24 and 5 among 5. These are participant counts, not counts of individual event episodes.
The listed serious adverse event terms include blood and lymphatic disorders- Other at 41.7%, adult respiratory distress syndrome at 40.0%, fever at 20.8%, infusion related reaction at 20.0%, lung infection at 20.0%, and aspartate aminotransferase increased at 20.0%. These are registry-listed percentages for event terms; they should not be read as a comparative estimate of risk between arms. The record does not report the event observation period or a statistical safety comparison.
Deaths are not reported in the registry record. The serious-event and other-event counts are descriptive and do not establish that C3a or the transplant regimen caused an event, nor do they establish a difference between the groups.
13. What the Result Does, and Does Not, Mean
The primary result describes how many participants had the C3a-primed unit predominate by day 180. The posted counts are 9 in the smaller-cell-dose group and 5 in the larger-cell-dose group, with arm denominators of 24 and 5. The endpoint is relevant to the study’s engraftment question, but it is not itself a measure of survival, relapse, or freedom from complications.
The registry does not provide an estimable statistical comparison for this binary endpoint. No confidence interval, p value, or model-based effect estimate is listed. Consequently, the counts alone do not establish whether the groups differed beyond what might be expected from sampling variation, or how precisely any difference could be estimated.
The outcome also does not answer every question raised by the study. The registry lists other outcomes, including neutrophil engraftment, blood and bone marrow chimerism, graft-versus-host disease, non-relapse mortality, overall survival, and relapse. Although secondary outcomes are posted, no analyses are listed. Their results cannot be inferred from the primary count.
The safety fields report affected-participant counts and several serious adverse event terms. These are useful descriptions of what the record lists, but they do not provide a causal comparison or a complete evaluation of safety. The registry does not provide comparative estimates or uncertainty intervals for those events.
Thus, the posted information supports a limited descriptive reading: it records day 180 unit predominance counts and safety summaries for the listed groups. It does not establish that C3a priming improves engraftment or other clinical outcomes, nor does it establish that it fails to do so. The reason for termination and a full statistical analysis are not reported in the registry record.
14. Why This Trial Matters Statistically
This trial raises a statistical question that is important in studies of double cord blood transplantation: whether a cord unit treated with C3a becomes the predominant unit by a specified follow-up time. A count-based endpoint can directly describe that biological outcome, and the day 180 timeframe makes the assessment point explicit. The registry also distinguishes groups according to whether the treated unit had the smaller or larger cell dose.
The record illustrates why design labels and analysis details matter. Allocation is labeled randomized, while the model is labeled single group, and the listed groups are defined by cell dose. Without a description of assignment and the intended contrast, readers cannot fully reconstruct the comparative design. The absence of an estimable two-arm analysis further limits statistical interpretation.
It also demonstrates the difference between a descriptive count and an inferential result. Counts tell readers what was recorded in each group. A comparative estimate and its uncertainty are needed to assess how precisely the data support a difference. Those elements are not listed for the primary endpoint. Planning illustrations based on an observed effect can aid hypothetical study planning, but they are not observed power and do not replace a prospective design rationale.
Finally, the registry lists a broad set of secondary outcomes, including clinically important measures beyond unit predominance. Without posted analyses or a reported multiplicity plan, the record cannot show how those outcomes were evaluated together. Clear outcome definitions, analysis populations, missing-data handling, and comparison methods would help readers judge the strength and scope of the evidence.
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 classifies allocation as randomized and the model as single group, while listing two groups based on the cell dose of the C3a-primed unit. The randomization method and the relationship between these classifications are not reported in the registry record. A separate non-C3a comparison group is not listed, limiting the comparisons described by the posted arms.
The primary outcome has counts for both groups, but the registry reports that values are missing or not estimable for a two-arm binary comparison. No analysis estimate, confidence interval, or p value is posted, and the record lists no analyses. As a result, the precision of the between-group contrast cannot be assessed from the registry record.
The arm denominators are 24 and 5, so the amount of information represented by each group is unequal. The primary outcome is reported at day 180, and the record does not describe other assessment times for this endpoint. It identifies two unevaluable participants and their reasons, but does not provide a general missing-data method or formal analysis-population definitions.
The registry lists 19 secondary outcomes but no analyses or multiplicity strategy. The study status is terminated, but the reason is not reported in the registry record. Details of the termination, sample-size justification, interim analyses, and statistical analysis plan are not reported in the registry record. These gaps constrain interpretation of the endpoint counts and the broader set of outcomes.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Donor Umbilical Cord Blood Transplant After Fludarabine Phosphate, Cyclophosphamide, and Total-Body Irradiation in Treating Patients With High-Risk Hematologic Cancer — NCT00963872.
- Registry record last updated 2017-12-28; status last verified 2017-12.
- Results first posted 2015-11-10.
- 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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Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
19. Record Summary
NCT00963872 is listed as a phase I/II study of unrelated donor umbilical cord blood transplantation for high-risk hematologic malignancies. The regimen includes fludarabine phosphate, cyclophosphamide, and total-body irradiation, with C3a priming of one of two cord blood units. The registry lists randomized allocation, no masking, a single-group model, enrollment of 31, and status as terminated.
The primary endpoint is the number of participants with the C3a unit predominating at day 180. The posted counts are 9 among 24 in the smaller-cell-dose group and 5 among 5 in the larger-cell-dose group. The record identifies two unevaluable participants and gives reasons. It does not provide an estimable two-arm analysis or list any analyses.
Nineteen secondary outcomes are posted. Safety summaries include affected-participant counts and serious adverse event terms. A statistical analysis plan, multiplicity approach, analysis populations, and reason for termination are not reported in the registry record.