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 of Vadastuximab Talirine Given Prior to or After Allogeneic Hematopoietic Stem Cell Transplant in AML Patients (NCT02614560), a non-randomized phase 1, phase 2 study. The primary outcome is Incidence of Adverse Events.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02614560 |
| Phase | Phase 1, Phase 2 |
| Condition | Acute Myeloid Leukemia |
| Allocation | Non-Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 14 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Seagen Inc. |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned adults with relapsed or refractory acute myeloid leukemia (AML), including patients described in the registry summary as having relapsed chemo-resistant AML. Participants were considered for treatment in sequence with a planned allogeneic hematopoietic stem cell transplant. The registry record does not provide further eligibility details or describe the characteristics of the participants enrolled in each arm.
Intervention
Vadastuximab talirine was given in one of two transplant sequences. In the pre-allo arm, it was used before transplant alongside reduced-intensity chemotherapy with melphalan and fludarabine. In the post-allo arm, it was given after transplant as maintenance therapy. The registry summary describes safety and tolerability, pharmacokinetics, and anti-leukemic activity as areas of interest; detailed dosing schedules are not reported in the registry record.
Comparator
The arms represent different treatment sequences rather than randomized treatment groups or a stated untreated control. Allocation was non-randomized, and masking was absent. As a result, the arm contrast is descriptive: differences could reflect the treatment sequence, differences among the patients selected for each sequence, or other factors. The registry record does not report a like-for-like control comparison.
Primary question
The primary outcome was the incidence of adverse events, measured as the number of participants with events over approximately 1 year. The study’s stated purpose also included finding a dose and assessing anti-leukemic activity before or after transplant. The registry lists response, duration of response, and overall survival among secondary outcomes, but does not provide their numerical results in the record. Thus, the available figures address safety descriptively and do not establish a comparative treatment effect.
3. Trial Design
This was a phase 1/2, parallel-arm, non-randomized study of vadastuximab talirine in patients with relapsed or refractory AML receiving treatment in sequence with allogeneic hematopoietic stem cell transplant. One arm used vadastuximab talirine before transplant with melphalan and fludarabine; the other used vadastuximab talirine after transplant. These are clinically different treatment settings, not two interchangeable versions of a single randomized intervention.
The registry reports enrollment of 14 participants. The pre-allo group lists 6 participants at risk for the adverse-event summaries, and the post-allo group lists 8. The study started in 2015-11, had a primary completion date of 2017-02-10, and is listed as terminated. The reason for termination is not reported in the registry record. The record does not describe the allocation process beyond stating that it was non-randomized, or give details about sites, dose escalation, treatment schedules, or follow-up procedures beyond the primary outcome timeframe.
Masking was absent. In a study where treatment timing is tied to transplant status, masking may be difficult, but the registry does not explain the choice. The lack of random allocation means that comparisons between arms can be affected by selection and clinical differences between participants entering the pre- and post-transplant settings. The groups should therefore be read as separate descriptive cohorts, not as a controlled estimate of what would happen if otherwise similar patients were assigned to one sequence rather than the other.
The registry describes safety and tolerability, dose finding, pharmacokinetics, and anti-leukemic activity as study aims. It lists best response of CR or CRi, duration of response, and overall survival as secondary outcomes. Detailed outcome estimates for those secondary measures are not reported in the registry record. The listed design information also does not establish a prespecified statistical comparison between arms.
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 | Pre-allo (Before Stem Cell Transplant) | Post-allo (After Stem Cell Transplant) |
|---|---|---|
| STARTED | 6 | 8 |
| COMPLETED | 0 | 6 |
| NOT COMPLETED | 6 | 2 |
Reasons for not completing this period:
| Reason | Pre-allo (Before Stem Cell Transplant) | Post-allo (After Stem Cell Transplant) |
|---|---|---|
| Death | 6 | 2 |
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 | Pre-allo (Before Stem Cell Transplant) | Post-allo (After Stem Cell Transplant) | Total |
|---|---|---|---|---|
| Participants analysed | 6 | 8 | 14 | |
| Age, Continuous | years | 58.0 (50 to 69) | 58.0 (25 to 64) | 58.0 (25 to 69) |
| Sex: Female, Male: Female | Participants | 3 | 3 | 6 |
| Sex: Female, Male: Male | Participants | 3 | 5 | 8 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 1 | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 6 | 7 | 13 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): White | Participants | 5 | 8 | 13 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Region of Enrollment: United States | participants | 6 | 8 | 14 |
| Eastern Cooperative Oncology Group (ECOG) Performance Status: Grade 0: Normal activity | Participants | 0 | 1 | 1 |
| Eastern Cooperative Oncology Group (ECOG) Performance Status: Grade 1: Symptoms but ambulatory | Participants | 6 | 7 | 13 |
6. Primary Endpoint
The registry lists the primary outcome as Incidence of Adverse Events, measured over Approximately 1 year.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is incidence of adverse events, expressed as the count of participants with events. The registry describes a timeframe of approximately 1 year. It defines adverse events using terminology that includes treatment-emergent events and grades events with the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03. The description also defines a serious adverse event by consequences such as fatality, life threat, hospitalization, disability, a birth defect, or other medical significance.
Counting participants with an event is a straightforward way to summarize how many people experienced a safety event during observation. It differs from counting every event: one participant can experience more than one event, while a participant-level count records whether that person experienced an event. This endpoint is useful for an early-phase study because safety and tolerability are central concerns when examining a treatment strategy and its dose. It does not, by itself, describe the event’s duration, recurrence, severity distribution, timing, or relationship to treatment.
The posted results separate serious adverse events, other adverse events, and deaths by treatment-sequence group. They do not provide a complete account of all event-level details or an adjusted comparison. The registry record does not report how missing safety observations were handled or define additional analysis populations. The endpoint therefore supports a descriptive reading of the listed participant counts, rather than a definitive estimate of comparative safety.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The safety results describe participants in two non-randomized treatment-sequence groups. For serious adverse events, the pre-allo group lists 5 affected participants among 6 at risk, and the post-allo group lists 2 among 8 at risk. For other adverse events, the listed counts are 6 among 6 in the pre-allo group and 8 among 8 in the post-allo group. The record also lists 6 deaths in the pre-allo group and 2 in the post-allo group. These are counts as recorded, not evidence that the treatment sequence caused the events or deaths.
The groups are not a like-for-like control comparison. The non-randomized allocation and different transplant timing mean participants could differ in ways that influence both treatment assignment and outcomes. Without details about baseline characteristics, event timing, treatment exposure, and adjustment, the observed counts cannot isolate a causal effect of vadastuximab talirine or establish which sequence has a more favorable safety profile.
The serious adverse-event terms reported include acute kidney injury at 33.3%, and febrile neutropenia, pyrexia, venoocclusive liver disease, graft versus host disease in gastrointestinal tract, and device related infection at 16.7% each. These registry percentages are listed terms; the record does not explain their denominator or provide enough detail to infer event counts from them. They should not be combined with the participant counts or interpreted as treatment-attributable risks.
Although the registry names response, duration of response, and overall survival as secondary outcomes, numerical estimates for those outcomes are not reported in the registry record. The posted safety counts therefore cannot answer the study’s anti-leukemic activity questions. Likewise, no confidence intervals or comparative effect estimates are reported for the adverse-event counts. Without those estimates, the precision of any between-group contrast is not quantified.
The study is listed as terminated, but the reason is not reported in the registry record. Termination alone does not show that a safety problem occurred, that a planned analysis was completed, or that a treatment effect was present or absent. The most supportable interpretation is limited to the descriptive counts and event terms recorded, with substantial uncertainty about causal comparisons and broader clinical outcomes.
9. Statistical Methods Explained
Statistical methods are not described in detail in the registry record. The outcome is a participant count: people are classified according to whether they had an adverse event in the relevant category. This is a binary outcome at the participant level, even though the results are reported as counts. The unit is the participant, not the number of event episodes. A participant with repeated events may still contribute once to a count of participants affected, depending on the endpoint definition; the record does not provide a detailed event-level rule.
What does a participant count tell the reader?
A count describes how many participants in a group were recorded as experiencing an outcome. It is easiest to interpret alongside the number of participants assessed for that outcome. The registry lists at-risk counts and affected counts for serious and other adverse events, separately by arm. These summaries do not show when events began, how long they lasted, whether they recurred, or whether they were judged related to treatment. They also do not reveal whether an event affected the same participant as another listed event.
A participant count is not the same as a rate over person-time. Follow-up duration can vary, and a fixed observation window does not guarantee that each participant was observed for the same length of time. The stated primary timeframe is approximately 1 year, but the registry does not report individual follow-up or how observation ended for each person. Therefore the counts should not be read as a time-adjusted incidence rate.
Why does non-random allocation matter?
Random allocation, when used, can help balance known and unknown prognostic factors on average between groups. This study is explicitly non-randomized. Treatment sequence also corresponds to whether vadastuximab talirine was given before or after transplant, so group membership may be associated with clinical circumstances. If the groups differ in factors that influence adverse events or survival, those differences can create an apparent contrast even when treatment sequence itself is not the cause. Statistical adjustment can sometimes address measured differences, but adjustment methods and covariates are not reported in the registry record.
The parallel-arm label indicates that the study has separate groups, but it does not make them comparable in the causal sense. In particular, the registry record does not describe a randomized allocation, a masked assessment, or an explicit control arm. Descriptive differences between the groups should not be presented as treatment effects.
How should uncertainty be understood?
A confidence interval, as a general statistical concept, describes a range of values compatible with data under a specified method and assumptions. It helps communicate the precision of an estimate. No confidence intervals for the primary adverse-event outcome are reported in the registry record. With limited group sizes, counts may be sensitive to outcomes in individual participants; the absence of intervals means the precision cannot be judged from an interval estimate. This does not justify creating a new interval from the summary counts, especially when the analysis population and handling of incomplete observation are not described.
A significance test would address compatibility with a statistical null hypothesis under its assumptions; it would not establish clinical importance or remove confounding in a non-randomized comparison. The registry record does not report a statistical test or adjusted comparison for the primary endpoint. The analysis method, any prespecified hypotheses, and any decision rules are not reported in the registry record.
What do the planning illustrations represent?
Sample-size illustrations based on an observed effect are planning scenarios, not observed power and not a description of how this trial was designed. The stated illustration assumptions include a two-sided significance level of 0.05, equal allocation, a normal approximation, and detection of a stated fraction of an observed effect. Such calculations ask how large a future study might need to be under those assumptions. They do not show that the current study had adequate power, and they cannot establish that a null finding would demonstrate no effect. No sample-size justification or prospective statistical plan is reported in the registry record.
For binary outcomes, planning estimates depend on the assumed event frequency, the effect to be detected, the allocation, and the chosen error rate. Changes in these assumptions can change the resulting sample-size requirement. A calculation based on an observed effect is especially uncertain when the observed estimate comes from a small, non-randomized study. It should be used as an illustration rather than as proof that the effect estimate is stable.
Why are event definitions important?
The registry describes grades using CTCAE v4.03, with grades ranging from mild through life-threatening and death related to an adverse event. It also gives a serious-event definition based on specified consequences or medical significance. Grade and seriousness are related but not identical concepts: seriousness reflects regulatory or clinical consequences, while grade characterizes severity. A serious adverse event count should not be treated as a count of all high-grade events unless the record explicitly says so. The registry does not report a full grade-by-grade breakdown or event attribution in the results summarized.
Overall, the available statistical information supports descriptive interpretation of participant counts and listed terms. It does not permit reconstruction of a prespecified analysis, a causal contrast, or a complete uncertainty assessment. The registry record does not report an analysis plan, covariate adjustment, interim analyses, or an approach to missing data.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 7 outcome measures and identifies best response of CR or CRi, duration of response, and overall survival as secondary outcomes. It does not report a multiplicity plan, a hierarchy among outcomes, or which results would be considered confirmatory. When several outcomes are examined, the chance of at least one apparently notable result can increase; this is a general statistical concern, not evidence that a particular finding in this study is false. The record does not describe any adjustment or other strategy for interpreting multiple outcomes.
No analysis entries are reported in the registry record. This does not establish whether analyses were performed outside the registry, but the record does not provide their methods or results. The statistical analysis plan, interim analyses, stopping rules, and rationale for the number of outcomes are not reported in the registry record.
Missing-data handling is also not described. The primary outcome is summarized using at-risk and affected participant counts, but the record does not explain whether all enrolled participants contributed to each endpoint, how incomplete follow-up was treated, or whether participants with missing outcome information were excluded or otherwise handled. These details matter because loss of observation can affect both the apparent number of participants with events and the comparability of groups.
The record does not define analysis populations, such as whether the results use all enrolled participants or a treatment-exposed subset. It also does not state whether adverse events were collected during a consistent exposure window for both arms. Without these details, readers cannot determine whether denominators and follow-up were handled consistently across outcomes or groups. The registry figures should therefore be read as the posted descriptive summaries, not as a complete account of the analysis process.
11. 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 |
|---|---|---|---|
| Pre-allo (Before Stem Cell Transplant) | 5 | 6 | 83.3% |
| Post-allo (After Stem Cell Transplant) | 2 | 8 | 25.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Pre-allo (Before Stem Cell Transplant) | 6 of 6 |
| Post-allo (After Stem Cell Transplant) | 2 of 8 |
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 |
|---|---|
| Pre-allo (Before Stem Cell Transplant) | 6 of 6 |
| Post-allo (After Stem Cell Transplant) | 8 of 8 |
Most frequent serious adverse event terms
| Event term | Organ system | Pre-allo (Before Stem Cell Transplant) | Post-allo (After Stem Cell Transplant) |
|---|---|---|---|
| Acute kidney injury | Renal and urinary disorders | 2 of 6 | 0 of 8 |
| Febrile neutropenia | Blood and lymphatic system disorders | 1 of 6 | 0 of 8 |
| Pyrexia | General disorders | 1 of 6 | 0 of 8 |
| Venoocclusive liver disease | Hepatobiliary disorders | 1 of 6 | 0 of 8 |
| Graft versus host disease in gastrointestinal tract | Immune system disorders | 1 of 6 | 0 of 8 |
| Graft versus host disease in lung | Immune system disorders | 0 of 6 | 1 of 8 |
| Device related infection | Infections and infestations | 1 of 6 | 0 of 8 |
| Parotitis | Infections and infestations | 1 of 6 | 0 of 8 |
| Pneumonia | Infections and infestations | 0 of 6 | 1 of 8 |
| Sepsis | Infections and infestations | 1 of 6 | 0 of 8 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Pre-allo (Before Stem Cell Transplant) | Post-allo (After Stem Cell Transplant) |
|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | 2 of 6 | 5 of 8 |
| Nausea | Gastrointestinal disorders | 5 of 6 | 2 of 8 |
| Fatigue | General disorders | 3 of 6 | 4 of 8 |
| Neutropenia | Blood and lymphatic system disorders | 1 of 6 | 5 of 8 |
| Vomiting | Gastrointestinal disorders | 4 of 6 | 2 of 8 |
| Oedema peripheral | General disorders | 5 of 6 | 1 of 8 |
| Headache | Nervous system disorders | 3 of 6 | 3 of 8 |
| Insomnia | Psychiatric disorders | 5 of 6 | 0 of 8 |
| Diarrhoea | Gastrointestinal disorders | 3 of 6 | 1 of 8 |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 4 of 6 | 0 of 8 |
Serious events with the highest arm-level rate: acute kidney injury (33.3%), febrile neutropenia (16.7%), pyrexia (16.7%), venoocclusive liver disease (16.7%), graft versus host disease in gastrointestinal tract (16.7%).
The serious adverse-event summaries list 5 affected participants among 6 at risk in the pre-allo group and 2 among 8 at risk in the post-allo group. The separate counts for other adverse events are 6 among 6 and 8 among 8, respectively. Deaths are listed as 6 in the pre-allo group and 2 in the post-allo group. The registry does not report whether deaths were considered related to treatment, and the counts should not be interpreted as treatment-caused deaths.
The serious-event terms include acute kidney injury (33.3%), febrile neutropenia (16.7%), pyrexia (16.7%), venoocclusive liver disease (16.7%), graft versus host disease in gastrointestinal tract (16.7%), and device related infection (16.7%). The denominator behind these term percentages is not described in the registry record. They are not necessarily percentages of all participants in either arm, so they should be read as reported rather than converted into arm-specific risks.
Seriousness and severity are distinct: the registry’s serious-event definition concerns consequences such as hospitalization or life threat, while CTCAE grades describe severity. The posted summaries do not give a complete grade breakdown, event attribution, or timing. Because allocation was non-randomized and the groups had different transplant timing, these counts are descriptive and do not support a direct causal safety comparison.
12. What the Result Does, and Does Not, Mean
The results show that adverse events were recorded in both treatment-sequence groups, and the registry reports serious events, other events, deaths, and selected serious-event terms. These observations are relevant to describing the experience captured in the record. They do not, on their own, establish whether vadastuximab talirine caused an event, whether one sequence is safer than the other, or how the results compare with another treatment.
The distinction between description and inference is central. A descriptive count answers how many participants were listed with an outcome in a group. A causal comparison asks what would have happened to similar participants under alternative treatment sequences. Since the groups were not randomized and the registry does not report adjustment for participant differences, the second question is not answered by the counts. The arms also correspond to different points around transplantation, which further limits a direct comparison.
The registry’s stated aims include dose finding and assessment of anti-leukemic activity, but numerical response and survival results are not reported in the registry record. Consequently, the safety summaries do not answer whether the treatment had anti-leukemic activity. The listed secondary outcomes identify measures of interest, not evidence of a particular outcome.
Nor does the record establish the precision of the observed counts. Confidence intervals and adjusted estimates are not reported for the primary endpoint. The counts should not be treated as stable estimates of event risk beyond the participants and observation represented in this study. In particular, the term percentages do not have a reported denominator in the record and should not be used to infer unreported event counts.
The study is listed as terminated, but the reason is not reported in the registry record. Termination is a status, not an explanation of why the study ended or what its results mean. Taken together, the record supports a cautious description of the posted safety data and the study design, while leaving causal safety comparisons, efficacy conclusions, and several analysis details unresolved.
13. Why This Trial Matters Statistically
This study raises statistical issues that often arise in early clinical research around transplantation. The treatment sequence differs according to whether vadastuximab talirine is used before or after allogeneic stem cell transplant. That distinction is clinically meaningful for interpreting the data because participants in the two settings may not be exchangeable. A simple side-by-side comparison can look informative while remaining unable to separate treatment effects from differences in selection, disease status, transplant context, or observation.
The endpoint also illustrates the importance of specifying what is counted. Participant-level adverse-event counts communicate how many people were affected, but do not describe all event episodes or their timing. Distinguishing serious events, other events, severity grades, and deaths is necessary for a coherent safety interpretation. The registry provides some of these categories, but not the detailed event-level context needed for a fuller account.
Early-phase studies may have safety and dose-finding purposes alongside activity assessments. That combination makes clear reporting of endpoint definitions, analysis populations, and statistical methods especially valuable. In this record, the purpose is described, but the statistical analysis plan and numerical results for the listed secondary outcomes are not reported. The reader should not mistake a stated objective for a reported result.
Finally, planning illustrations derived from an observed effect are not equivalent to prospective design justification. Their assumptions need to be visible, and their outputs should be interpreted as scenarios rather than evidence of observed power. This distinction matters when small studies are used to inform planning for later research. The record’s limitations therefore affect not only the interpretation of this study but also how confidently its estimates can be carried forward.
14. 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.
Several limitations are specific to the information reported for this trial. It was non-randomized and unmasked, and the two arms correspond to treatment before versus after transplant. The arms are not a like-for-like control comparison. Any difference in event counts could reflect participant selection, transplant timing, or other group differences; the registry does not report the baseline characteristics needed to assess this possibility or an adjusted analysis addressing it.
The enrolled population is described broadly as patients with relapsed or refractory AML, with the study summary referring to relapsed chemo-resistant AML. Further eligibility criteria and arm-level participant characteristics are not reported in the registry record. The record also does not give detailed treatment schedules, doses, exposure duration, or individual follow-up. This limits interpretation of the approximately 1-year adverse-event timeframe and whether outcome observation was comparable across groups.
For safety, the record provides participant counts and selected serious-event terms, but not complete event-level descriptions, attribution, timing, recurrence, or a full severity breakdown. The denominator for the listed term percentages is not stated. Death counts are reported without a stated treatment relationship. Missing-data procedures and analysis populations are not reported.
Numerical results for the listed response, duration-of-response, and overall-survival outcomes are not reported in the registry record, nor are comparative effect estimates or confidence intervals for the primary endpoint. The registry lists the study as terminated, but does not report the reason. These gaps prevent a full assessment of efficacy, precision, and the circumstances behind the study status.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study of Vadastuximab Talirine Given Prior to or After Allogeneic Hematopoietic Stem Cell Transplant in AML Patients — NCT02614560.
- Registry record last updated 2019-01-09; status last verified 2018-12.
- Results first posted 2019-01-09.
- 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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18. Record Summary
The registry record describes a phase 1/2, parallel, non-randomized, unmasked study of vadastuximab talirine in relapsed or refractory AML. The pre-allo arm used treatment before transplant with melphalan and fludarabine; the post-allo arm used treatment after transplant. Enrollment is listed as 14, and the study status is terminated. Its primary outcome is incidence of adverse events over approximately 1 year.
The posted results include serious and other adverse-event participant counts, deaths, and selected serious-event terms. The registry lists best response of CR or CRi, duration of response, and overall survival as secondary outcomes, but numerical results for those outcomes are not reported in the registry record. The record does not report the reason for termination, statistical analysis plan, missing-data approach, or comparative estimates and confidence intervals for the primary endpoint. The safety counts are therefore descriptive and do not support a causal comparison between the two treatment sequences.