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 the Safety, Tolerability and Effectiveness of EZM0414 (IPN60210) Investigative Product in Participants With Relapsed/Refractory Multiple Myeloma and Relapsed/Refractory Diffuse Large B Cell Lymphoma (NCT05121103), a na phase 1 study. The primary outcome is Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05121103 |
| Phase | Phase 1 |
| Condition | Multiple Myeloma, Refractory, Diffuse Large B-Cell Lymphoma, Diffuse Large B Cell Lymphoma Refractory |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 13 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Epizyme, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
Participants with relapsed/refractory multiple myeloma or relapsed/refractory diffuse large B-cell lymphoma were eligible for the study. The primary safety population included participants who received at least 1 dose of treatment in Part 1. The registry record reports enrollment of 13 participants, but does not report how those participants were distributed by cancer type or other baseline characteristics.
Intervention
The study treatment was EZM0414, a SETD2 inhibitor. The arm description states that it was administered orally once daily without food in continuous 28-day cycles. The safety results identify groups at 100 mg, 200 mg, and 300 mg. The registry summary says six dose levels would be tested during phase 1, but does not report results for all six levels.
Comparator
There was no control group. The registry describes an open-label, single-group study, with allocation listed as not applicable and no masking. The dose groups are not randomized comparison groups, so differences between them cannot be interpreted as controlled estimates of dose effects.
Primary question
The primary Part 1 question was how many participants experienced treatment-emergent adverse events and treatment-emergent serious adverse events. The registry record defines these events over the period from the first dose through 30 days after the last dose. The study’s primary objective was safety and tolerability; the planned Part 2 objective also included effectiveness, but Part 2 was not started.
These details frame the results as an early-phase safety description, not a controlled estimate of effectiveness. The record does not report a comparative question between EZM0414 and another treatment, nor does it report outcome estimates by cancer type.
3. Trial Design
This was a phase 1/1b, open-label, multicenter, two-part study of EZM0414. The design was single-group, with no masking and allocation listed as not applicable. Participants and study staff were not blinded according to the registry design description. The study included people with relapsed/refractory multiple myeloma and relapsed/refractory diffuse large B-cell lymphoma.
The registry summary describes phase 1 as testing six dose levels to identify the most tolerated dose. The safety results list three groups: EZM0414 100 mg, 200 mg, and 300 mg. The record does not report the status or results of the other planned dose levels, or a dose-escalation decision. It describes dosing in 28-day cycles; the arm description specifies oral administration once daily without food.
Part 1 focused on safety and tolerability. Part 2 was intended to assess safety and tolerability and, in its primary objective, effectiveness. Secondary outcomes named for Part 2 included progression-free survival, disease control rate, and duration of response. The registry record states that the study was terminated before Part 1 was completed and that Part 2 was not started. Therefore, the Part 2 outcomes were not assessed in this study record.
Enrollment was 13. The study start date was 2022-05-31, and the primary completion date was 2024-04-30. The status is terminated. The reason for termination is not reported in the registry record. The record does not report a randomized comparison, so the dose groups should be read as descriptive groups within an early-phase study, not as like-for-like treatment 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.
Before assignment: The study was planned to have a screening period (28 days), treatment period (Part 1 and Part 2) and safety follow-up period (30 days). Due to early study termination, only results of the Part 1 are presented. A total of 13 participants were enrolled in Part 1 of the study. EZM0414 is also referred to as IPN60210.
Overall Study
| Stage | Part 1: EZM0414 100 mg | Part 1: EZM0414 200 mg | Part 1: EZM0414 300 mg |
|---|---|---|---|
| STARTED | 4 | 3 | 6 |
| COMPLETED | 0 | 0 | 0 |
| NOT COMPLETED | 4 | 3 | 6 |
Reasons for not completing this period:
| Reason | Part 1: EZM0414 100 mg | Part 1: EZM0414 200 mg | Part 1: EZM0414 300 mg |
|---|---|---|---|
| Progressive disease | 2 | 1 | 6 |
| Physician Decision | 2 | 1 | 0 |
| Withdrawal by Subject | 0 | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
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: The safety population included all participants who received at least 1 dose of the study treatment in Part 1.
| Characteristic | Unit | Part 1: EZM0414 100 mg | Part 1: EZM0414 200 mg | Part 1: EZM0414 300 mg | Total |
|---|---|---|---|---|---|
| Participants analysed | 4 | 3 | 6 | 13 | |
| Age, Continuous | years | 61.5 (SD 7.42) | 70.3 (SD 6.66) | 68.0 (SD 13.11) | 66.5 (SD 10.29) |
| Sex: Female, Male: Female | Participants | 2 | 2 | 4 | 8 |
| Sex: Female, Male: Male | Participants | 2 | 1 | 2 | 5 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 1 | 1 | 2 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 3 | 2 | 5 | 10 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 1 | 0 | 0 | 1 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 2 | 0 | 1 | 3 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 1 | 1 | 2 |
| Race (NIH/OMB): White | Participants | 1 | 2 | 3 | 6 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 | 0 | 1 | 2 |
6. Primary Endpoint
The registry lists the primary outcome as Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs), measured over From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary Part 1 endpoint is the number of participants with treatment-emergent adverse events and treatment-emergent serious adverse events. The registry defines an adverse event as an untoward medical occurrence in a participant given a medicinal product; the event does not need to have a causal relationship with the treatment. A serious adverse event is an event meeting the listed seriousness criteria, including death, a life-threatening event, hospitalization or prolonged hospitalization, persistent or significant disability or incapacity, congenital abnormality or birth defect, or another important medical event.
A treatment-emergent adverse event is defined as an adverse event that started or worsened in severity on or after the first dose through 30 days after the end of treatment. The stated observation period begins on Day 1 and runs through Day 57, up to approximately 87 days. These definitions establish which events count and the time window in which they are assessed.
Counting participants with events is useful in an early-phase safety assessment because it describes how many people experienced an event during treatment and follow-up. It is a participant-level count, not a measure of event frequency per unit of time, event severity distribution, or proof that treatment caused an event. The registry record does not report a treatment-effect estimate, confidence interval, or comparative analysis for this endpoint. The study’s early termination also means the intended Part 1 assessment was not completed.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted safety results describe three dose groups: 100 mg, 200 mg, and 300 mg. For serious adverse events, the record lists 4 participants at risk and 1 affected in the 100 mg group, 3 at risk and 0 affected in the 200 mg group, and 6 at risk and 1 affected in the 300 mg group. These are descriptive counts within an open-label, single-group study. They do not establish whether event counts differ because of dose, chance, participant characteristics, time exposed, or other factors.
For other adverse events, the record lists 4 participants at risk and 3 affected at 100 mg, 3 at risk and 3 affected at 200 mg, and 6 at risk and 5 affected at 300 mg. The record does not provide comparative estimates or uncertainty intervals for these counts. With small groups, a count can change substantially in relation to group size when one participant’s event status differs. This is a general statistical consideration, not evidence of a specific treatment effect in these data.
The listed serious-event terms are urosepsis at 25.0%, abdominal infection at 16.7%, and small intestinal perforation at 16.7%. The record does not explain the denominator used for these term percentages, whether participants could contribute more than one term, or how the terms were assigned across dose groups. They should therefore be read as registry-listed event-term percentages rather than as a complete patient-level account.
The listed death count is 0 in each dose group. That is a descriptive safety finding for the listed groups, not evidence that the risk of death is absent. The record does not provide a longer-term mortality analysis or a controlled comparison.
The trial status matters for interpretation. The registry says the study was terminated before Part 1 was completed and Part 2 was not started. Thus, the counts reflect an incomplete early-phase study rather than completion of the planned assessment. No Part 2 effectiveness results are reported. No inferential analyses are listed in the registry record, and no confidence intervals or p-values are reported. The counts can describe what was recorded among the listed participants, but they cannot support a conclusion about effectiveness or a reliable comparison between doses.
9. Statistical Methods Explained
What kind of result is a participant count?
The primary endpoint is a count of participants with treatment-emergent adverse events and treatment-emergent serious adverse events. A participant count records whether a participant experienced one or more qualifying events during the defined observation period. It does not necessarily count each separate event, and it does not show how long an event lasted or how severe every event was. Those details are not reported in the registry record for the primary endpoint.
For a count to be interpretable, its denominator matters. The adverse-event results give the number at risk and the number affected in each dose group. Reading the affected count alongside the group size makes clear how many people contributed to the displayed group result. These small group sizes also mean the counts are descriptive and potentially imprecise. General statistical principle: when the number of observations is limited, estimates commonly have greater uncertainty, and individual observations can have a larger influence on the apparent pattern.
Why are the dose groups not a treatment comparison?
A controlled comparison requires a design that supports a fair contrast between groups. Here, the registry describes a single-group, open-label study with allocation not applicable. The dose groups are not reported as randomized arms, and there is no untreated or active comparator. Therefore, a difference in observed counts across doses cannot be attributed to dose alone. Participant mix, exposure duration, timing, and chance may also affect observed counts. The registry record does not report an adjusted analysis that could address these issues.
General statistical principle: random allocation can help balance measured and unmeasured factors between groups, while masking can reduce some forms of assessment or reporting bias. Neither feature is part of the listed design. This does not invalidate descriptive safety reporting, but it limits causal interpretation and makes comparisons across dose groups especially cautious.
What would uncertainty estimates add?
A confidence interval is a range of values compatible with the observed data under a specified statistical method. In general, it communicates the precision of an estimate; a wide interval indicates that the data are consistent with a broad range of values. The registry record does not report confidence intervals for the primary safety counts. It also reports no p-values or inferential analyses. Without such estimates, the counts should not be described as statistically distinguishable or as demonstrating a precise event rate.
Because the endpoint is a count of participants with an event, rates or proportions can be useful in some analyses, but they require clear denominators and a specified analysis method. The registry’s safety results identify participants at risk and affected; the record does not provide an adjusted risk estimate or an exposure-adjusted rate. No new percentages or comparisons can be inferred from the counts without calculating results beyond the registry record.
Why can serious events and other events tell different stories?
Seriousness is a classification based on the listed regulatory criteria, not a judgment that an event was caused by treatment. An adverse event may be serious or non-serious, and an event’s classification does not itself establish causation. The registry definition explicitly allows adverse events without a necessary causal relationship. The posted counts therefore describe reported events within the defined period, not proven treatment-related harms.
General statistical principle: event-term summaries can be difficult to interpret if the denominator, coding rules, and handling of multiple events per participant are unclear. The record lists three serious-event terms with percentages, but does not report the denominator or whether terms may overlap within participants. Those percentages should not be combined or treated as participant-level risks.
How should the planning illustrations be understood?
The registry’s associated planning illustrations use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. They frame the effect to detect as a stated fraction of an observed effect. These are planning assumptions, not reported features of this trial’s single-group, nonrandomized design. They do not convert the dose groups into randomized comparisons, and they are not observed power. The record does not report that these assumptions were the basis of the study’s own design or sample-size justification; that justification is not reported in the registry record.
General statistical principle: sample-size calculations describe the number of participants that a hypothetical design would require under specified assumptions. They do not measure whether a completed study had adequate power after the fact. The record gives no trial-specific sample-size justification, no interim-analysis plan, and no inferential statistical plan. Those items are not reported in the registry record, so they cannot be reconstructed from the posted event counts.
The study’s termination before Part 1 completion is a further limit on interpretation. The participant counts are useful as a description of recorded safety observations, but they cannot stand in for a completed assessment or provide evidence about outcomes that were planned for Part 2.
10. Multiplicity, Missing Data and Analysis Populations
The registry record identifies a primary safety endpoint and lists Part 2 secondary outcomes of progression-free survival, disease control rate, and duration of response. However, Part 2 was not started, so the record does not report results for those secondary outcomes. It does not report a multiplicity adjustment or a plan for controlling the chance of false-positive findings across multiple outcomes. Such a plan is not reported in the registry record.
The record lists no analysis entries. It does not report how missing endpoint data were handled, whether participants who stopped treatment early remained under observation, or whether any sensitivity analyses were performed. The approach to missing data is not reported in the registry record. No assumptions about missingness or imputation can be inferred from the posted counts.
The primary endpoint’s stated safety population includes all participants who received at least 1 dose in Part 1. The registry also says the study was terminated before Part 1 was completed. It does not provide a fuller account of exclusions, exposure duration, or participant-level availability for each endpoint. Those details are not reported in the registry record.
General statistical principle: multiplicity matters when several outcomes or repeated analyses are used to support confirmatory claims, because examining multiple results can increase the chance of a seemingly notable result arising by chance. Missing-data methods matter because conclusions can depend on why observations are absent and how the analysis accounts for them. In this record, neither a multiplicity strategy nor a missing-data strategy is reported, and the early termination and absence of Part 2 results constrain what can be evaluated.
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 |
|---|---|---|---|
| Part 1: EZM0414 100 mg | 1 | 4 | 25.0% |
| Part 1: EZM0414 200 mg | 0 | 3 | 0.0% |
| Part 1: EZM0414 300 mg | 1 | 6 | 16.7% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Part 1: EZM0414 100 mg | 0 of 4 |
| Part 1: EZM0414 200 mg | 0 of 3 |
| Part 1: EZM0414 300 mg | 0 of 6 |
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 |
|---|---|
| Part 1: EZM0414 100 mg | 3 of 4 |
| Part 1: EZM0414 200 mg | 3 of 3 |
| Part 1: EZM0414 300 mg | 5 of 6 |
Most frequent serious adverse event terms
| Event term | Organ system | Part 1: EZM0414 100 mg | Part 1: EZM0414 200 mg | Part 1: EZM0414 300 mg |
|---|---|---|---|---|
| Abdominal infection | Infections and infestations | 0 of 4 | 0 of 3 | 1 of 6 |
| Urosepsis | Infections and infestations | 1 of 4 | 0 of 3 | 0 of 6 |
| Small intestinal perforation | Gastrointestinal disorders | 0 of 4 | 0 of 3 | 1 of 6 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Part 1: EZM0414 100 mg | Part 1: EZM0414 200 mg | Part 1: EZM0414 300 mg |
|---|---|---|---|---|
| Platelet count decreased | Investigations | 1 of 4 | 2 of 3 | 1 of 6 |
| Anaemia | Blood and lymphatic system disorders | 2 of 4 | 1 of 3 | 1 of 6 |
| Fatigue | General disorders | 2 of 4 | 1 of 3 | 1 of 6 |
| Back pain | Musculoskeletal and connective tissue disorders | 1 of 4 | 1 of 3 | 2 of 6 |
| Hypotension | Vascular disorders | 1 of 4 | 0 of 3 | 3 of 6 |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 0 of 4 | 2 of 3 | 1 of 6 |
| Headache | Nervous system disorders | 1 of 4 | 1 of 3 | 1 of 6 |
| Lymphocyte count decreased | Investigations | 0 of 4 | 1 of 3 | 1 of 6 |
| Neutrophil count decreased | Investigations | 1 of 4 | 1 of 3 | 0 of 6 |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 2 of 4 | 0 of 3 | 0 of 6 |
Serious events with the highest arm-level rate: urosepsis (25.0%), abdominal infection (16.7%), small intestinal perforation (16.7%).
The serious adverse-event counts are listed by dose group. At 100 mg, 4 participants were at risk and 1 was affected; at 200 mg, 3 were at risk and 0 were affected; at 300 mg, 6 were at risk and 1 was affected. The record lists 0 deaths for each group. These are observed counts, not comparisons against a control group.
The separate other-adverse-event counts are 3 affected among 4 at risk at 100 mg, 3 among 3 at risk at 200 mg, and 5 among 6 at risk at 300 mg. The registry record does not clarify in these results whether each participant could contribute to more than one event term, or provide exposure-adjusted rates. The counts should not be read as a ranking of doses or as evidence that a dose caused an event.
The listed serious-event terms are urosepsis (25.0%), abdominal infection (16.7%), and small intestinal perforation (16.7%). The denominator for these term percentages and any overlap between terms are not reported in the registry record. The event definition also states that an adverse event does not necessarily have a causal relationship with treatment. Accordingly, the event counts and terms describe safety observations, not proof of treatment causation.
12. What the Result Does, and Does Not, Mean
The registry record documents an early-phase safety study of EZM0414 in participants with relapsed/refractory multiple myeloma and relapsed/refractory diffuse large B-cell lymphoma. It reports event counts for three dose groups and identifies the primary endpoint as the number of participants with treatment-emergent adverse events and treatment-emergent serious adverse events. These data are descriptive: they report what was recorded in the listed groups during the specified safety observation period.
The data do not establish that EZM0414 caused any particular adverse event. The registry’s event definition does not require a causal link, and the study did not include a control group. The counts also do not provide a reliable comparison among doses. A nonrandomized dose-group pattern may reflect factors other than dose, and the record does not provide adjusted estimates or uncertainty intervals.
The counts do not establish effectiveness. Although the registry describes an effectiveness objective for Part 2 and lists progression-free survival, disease control rate, and duration of response as secondary outcomes, Part 2 was not started. No results for those outcomes are reported. No analyses or comparative effectiveness estimates are listed.
The findings also should not be treated as a completed evaluation of the planned study. The registry states that the study was terminated before Part 1 was completed. The reason for termination is not reported in the registry record. The number of enrolled participants was 13, but the record does not report all details needed to assess representativeness, exposure, or outcome completeness.
In general, a small, uncontrolled early-phase study can provide a preliminary description of events observed during treatment and can inform further investigation. It cannot, by itself, distinguish treatment effects from background events or other influences with the strength of a controlled comparison. That general limitation applies to interpretation of these posted counts; it is not an additional finding about the study.
13. Why This Trial Matters Statistically
This study illustrates a distinction central to biostatistical interpretation: a safety count is not the same as a causal estimate. The registry reports participants affected by adverse events in dose groups, but the single-group, open-label design has no randomized comparator. As a result, the observations can describe what occurred among participants who received treatment, while leaving the cause of those events unresolved.
The record also shows why trial status and completion matter. Part 1 was not completed and Part 2 was not started. The planned study included additional dose-level work and a later phase with effectiveness objectives, but the registry does not report a completed assessment of those aims. Statistical interpretation must therefore stay close to the actual scope of the posted results rather than treating the original objectives as completed findings.
Another important lesson is the role of denominators and uncertainty. The reported group sizes are limited, and the event counts are presented without confidence intervals or inferential analyses. General statistical principle: counts from small groups can be sensitive to individual observations, and uncertainty estimates help readers distinguish a point estimate from the range of values compatible with the data. No such estimates are reported for the primary endpoint.
Finally, planned sample-size illustrations do not substitute for a trial-specific design justification or observed evidence. The registry does not report its own sample-size justification, interim-analysis plan, or statistical analysis plan. The planning assumptions associated with the record are hypothetical and differ from the study’s single-group design. Keeping these distinctions clear prevents descriptive safety information from being overstated as comparative or confirmatory evidence.
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 arise from the design and status recorded for this study. It was open-label and single-group, with no randomized comparator. Therefore, observed event counts cannot isolate a treatment effect or support a like-for-like comparison between dose groups. Differences in counts may reflect participant characteristics, exposure, or chance as well as dose.
The study was terminated before Part 1 was completed, and Part 2 was not started. The reason for termination is not reported in the registry record. Enrollment was 13, and the listed dose groups are small. The record does not report how participants were distributed by cancer type, how long each participant received treatment, or whether follow-up was complete for all participants. These details limit assessment of the context and completeness of the safety observations.
The primary endpoint is a participant count, but the record does not provide confidence intervals, inferential analyses, exposure-adjusted rates, or a detailed account of event severity and attribution. For the listed serious-event term percentages, the denominator and possible overlap between terms are not reported in the registry record. Missing-data handling, multiplicity procedures, and the trial’s own sample-size justification are also not reported.
The registry lists six planned phase 1 dose levels but provides safety groups for 100 mg, 200 mg, and 300 mg. Results or disposition for the other planned levels are not reported in the registry record. Part 2 outcomes were not assessed because that part did not start. Together, these limits mean the posted information is a partial descriptive safety record, not a completed evaluation of safety across the planned study or an effectiveness assessment.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study of the Safety, Tolerability and Effectiveness of EZM0414 (IPN60210) Investigative Product in Participants With Relapsed/Refractory Multiple Myeloma and Relapsed/Refractory Diffuse Large B Cell Lymphoma — NCT05121103.
- Registry record last updated 2025-06-22; status last verified 2025-06.
- Results first posted 2025-05-11.
- 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
NCT05121103 is a phase 1/1b, open-label, multicenter, single-group study of EZM0414 in relapsed/refractory multiple myeloma and relapsed/refractory diffuse large B-cell lymphoma. The registry lists enrollment of 13, a start date of 2022-05-31, and a primary completion date of 2024-04-30. The study status is terminated.
The primary Part 1 endpoint counts participants with treatment-emergent adverse events and treatment-emergent serious adverse events. Safety results are listed for EZM0414 100 mg, 200 mg, and 300 mg. The registry states that the study ended before Part 1 was completed and that Part 2 was not started. The reason for termination, statistical analysis plan, missing-data methods, multiplicity strategy, and trial-specific sample-size justification are not reported in the registry record.