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 Study of Eribulin Mesylate in Combination With PEGylated Recombinant Human Hyaluronidase (PEGPH20) Versus Eribulin Mesylate Alone in Subjects With Human Epidermal Growth Factor Receptor 2 (HER2)-Negative, High-Hyaluronan (HA) Metastatic Breast Cancer (MBC) (NCT02753595), a randomized phase 1, phase 2 study. The primary outcome is Phase 1b: Recommended Phase 2 Dose (RP2D) of Eribulin Mesylate in Combination With PEGPH20.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02753595 |
| Phase | Phase 1, Phase 2 |
| Condition | Metastatic Breast Cancer |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 25 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Eisai Inc. |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned participants with HER2-negative metastatic breast cancer. Phase 1b included participants previously treated with up to two lines of systemic anticancer therapy in the metastatic setting. The Phase 2 objective focused on participants with high-hyaluronan metastatic disease who had received up to two such lines.
Intervention
The experimental treatment combined eribulin mesylate with PEGylated recombinant human hyaluronidase, called PEGPH20. In Phase 1b, the study evaluated dose levels to determine a recommended Phase 2 dose. In Phase 2, participants assigned to the combination were to receive the established dose.
Comparator
The Phase 2 comparator was eribulin mesylate alone. The registry describes the eribulin-alone dose as 1.4 mg/m^2. The listed comparison is therefore between the combination and eribulin alone, but the primary outcome record concerns Phase 1b dose selection rather than a comparative Phase 2 outcome.
Primary question
The registered primary outcome asks what recommended Phase 2 dose of eribulin mesylate plus PEGPH20 is supported by Phase 1b safety and tolerability. Separately, the Phase 2 objective was to evaluate objective response rate in the high-hyaluronan population. The registry record does not report results for either objective.
The study was randomized, open-label, and parallel-group, with Phase 1b and Phase 2 components. Its listed enrollment was 25. The central statistical distinction is that the registered primary outcome is a dose-selection measure, not an estimate of the treatment difference between the Phase 2 combination and eribulin-alone groups. The registry record does not provide an analyzed between-group effect for response, nor does it report a confidence interval or hypothesis-test result for that comparison.
The study therefore raises two related but separate questions: whether a combination dose met the Phase 1b dose-limiting-toxicity rule, and what objective response rate was observed in Phase 2. The record describes both aims, but its posted results do not resolve either question. The available safety counts describe adverse events in Phase 1b groups; they do not substitute for the dose-selection result or for a Phase 2 response analysis.
3. Trial Design
This was a randomized, open-label, multicenter, parallel Phase 1b/2 study. The registry lists the study as terminated, with a start date of 2016-07-13 and a primary completion date of 2019-08-16. The reason for termination is not reported in the registry record. The enrollment listed in the record is 25.
The Phase 1b component was intended to determine safety, tolerability, and the recommended Phase 2 dose of eribulin mesylate plus PEGPH20. The dose-finding description lists PEGPH20 dose level 1 as 3.0 mcg/kg and dose level 0 as 1.6 mcg/kg; both are followed by eribulin mesylate at 1.4 mg/m^2. The Phase 1b dose rule defined the maximum tolerated dose as the dose at which no more than 1 of 6 evaluable participants experienced a dose-limiting toxicity during the first 21 days of treatment. The recommended Phase 2 dose was defined as the maximum tolerated dose or less. The record says that the dose was to be confirmed in a Phase 1b expansion part.
In Phase 2, the planned combination group was to receive eribulin mesylate and PEGPH20 at the established recommended dose. The eribulin-alone group was to receive eribulin mesylate at 1.4 mg/m^2. The Phase 2 objective was to evaluate objective response rate in participants with HER2-negative, high-hyaluronan metastatic breast cancer previously treated with up to two lines of systemic anticancer therapy in the metastatic setting.
Randomization describes allocation by chance; open-label means the registry lists no masking. The registry record does not report the allocation procedure, the randomization ratio, or further operational details. The status and dates do not establish why the study was terminated or whether every planned component was completed.
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: Study terminated early during Phase 1b Expansion Part and before initiating Phase 2 due to poor accrual. Data reported is based on initial dosing levels given to participants during Phase 1b. Combined data for participants who received Dose level 0 during determination of RP2D and confirmation of RP2D (Expansion Part) are reported as planned.
Overall Study
| Stage | Phase 1b: Dose Level 1 | Phase 1b: Dose Level 0 and Expansion Part |
|---|---|---|
| STARTED | 5 | 9 |
| COMPLETED | 3 | 7 |
| NOT COMPLETED | 2 | 2 |
Reasons for not completing this period:
| Reason | Phase 1b: Dose Level 1 | Phase 1b: Dose Level 0 and Expansion Part |
|---|---|---|
| Sponsor termination | 2 | 2 |
Analysis population for the primary outcome, as defined in the registry: The safety analysis set included participants who received at least 1 dose of the study drug in Phase 1b.
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 analysis set included participants who received at least 1 dose of the study drug in Phase 1b.
| Characteristic | Unit | Phase 1b: Dose Level 1 | Phase 1b: Dose Level 0 and Expansion Part | Total |
|---|---|---|---|---|
| Participants analysed | 5 | 9 | 14 | |
| Age, Continuous | years | 55.2 (SD 13.10) | 52.8 (SD 11.86) | 53.6 (SD 11.87) |
| Sex: Female, Male: Female | Participants | 5 | 9 | 14 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 3 | 3 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 5 | 6 | 11 |
| 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 | 3 | 1 | 4 |
| Race (NIH/OMB): White | Participants | 2 | 4 | 6 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 4 | 4 |
6. Primary Endpoint
The registry lists the primary outcome as Phase 1b: Recommended Phase 2 Dose (RP2D) of Eribulin Mesylate in Combination With PEGPH20, measured over Up to Cycle 28 (Cycle Length= 21 days).
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | mg/m^2 |
| Endpoint classification | not reduced to a single comparison |
The registered primary outcome is the Phase 1b recommended Phase 2 dose of eribulin mesylate in combination with PEGPH20. It is a dose-selection endpoint, expressed in mg/m^2, rather than a direct measure of tumor response. Its purpose is to identify a dose level that meets the study’s prespecified dose-limiting-toxicity rule and is considered appropriate for evaluation in Phase 2. The registry defines the recommended dose as the maximum tolerated dose or less.
For the dose rule, the registry describes dose-limiting toxicity during the first 21 days of treatment, ending with Cycle 1. A dose level qualified as the maximum tolerated dose if no more than 1 of 6 evaluable participants experienced a dose-limiting toxicity in that period. The record also says that the recommended dose was to be confirmed in the Phase 1b expansion part. These definitions explain how the endpoint was intended to be determined; they do not state which dose was selected.
The study’s Phase 2 objective was objective response rate, a measure of the proportion of participants meeting the study’s response criteria. That objective is described in the registry summary, but the primary outcome listing is the Phase 1b dose measure. Response criteria and a Phase 2 response result are not reported in the registry record. No conclusion about response can be drawn from the dose endpoint or from the adverse-event counts.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies the study’s aims and dose-finding rule, but it does not report the primary outcome value. It does not state whether dose level 1 or dose level 0 was selected as the recommended Phase 2 dose, whether either dose met the toxicity rule, or how the Phase 1b expansion confirmation proceeded. The stated enrollment and the adverse-event counts do not answer those questions. They should not be treated as a substitute for the outcome analysis.
Nor does the record report the Phase 2 objective response rate or a comparison between the combination and eribulin alone. There are no posted estimates, confidence intervals, or hypothesis-test results for that objective in the record. The Phase 2 objective is part of the study description, but an objective is not itself evidence of an observed result. The registry record also does not report the response criteria or the analysis population used to evaluate response.
The adverse-event listing gives serious-event counts for two Phase 1b groupings: Dose Level 1 and Dose Level 0 and Expansion Part. It reports 1 affected participant among 5 at risk for the first grouping and 3 among 9 at risk for the second. These are descriptive counts for the listed groups. They do not establish a causal relationship with study treatment, and the grouped record does not provide the detail needed to compare risks while accounting for participant characteristics, exposure, or follow-up. The registry also lists deaths as 2 and 3 in the respective groupings; the record does not state causes or attribute these deaths to treatment.
General statistical interpretation: an estimate describes the observed data, while a confidence interval conveys uncertainty around that estimate under the assumptions of the analysis. Neither can be interpreted when no estimate or interval is posted. A non-significant result, if one had been reported, would not by itself establish equivalence or absence of an effect; in this record, no such test result is reported at all.
The study is listed as terminated, but the reason is not reported in the registry record. Termination alone does not show whether the decision reflected safety, feasibility, recruitment, an administrative issue, or any other cause. The available record supports a description of the design, planned objectives, dose rule, and selected adverse-event counts, but not an efficacy conclusion or a definitive dose-selection conclusion.
9. Statistical Methods Explained
The registry record describes a Phase 1b dose-finding component followed by a Phase 2 component, with randomization and no masking. The two components address different statistical questions. Phase 1b uses observed dose-limiting toxicities to guide dose selection. Phase 2 was intended to evaluate objective response rate for the combination, with eribulin mesylate alone as the comparator. A dose-selection result and a comparative response estimate are not interchangeable: the former selects a dose under a safety rule, while the latter describes outcomes in treatment groups.
What does the dose-limiting-toxicity rule mean?
The registered rule defines the maximum tolerated dose as a dose level at which no more than 1 of 6 evaluable participants has a dose-limiting toxicity during the first 21 days of treatment. This is a decision rule applied to early-cycle safety observations. It is not a guarantee that later toxicities will not occur, and it is not a measure of antitumor response. The registry defines the recommended Phase 2 dose as the maximum tolerated dose or less, and says the chosen dose was to be confirmed in the Phase 1b expansion part.
General statistical explanation: dose-finding rules simplify a complex balance of observed toxicity and dose level into an operational decision. Small groups can make the observed toxicity pattern sensitive to the outcome of individual participants. The rule does not, by itself, quantify the probability of toxicity at every dose or characterize uncertainty in a dose-response relationship. The registry record does not report a model-based dose-finding method, additional decision rules, or a numerical dose-selection result.
What does the Phase 2 objective measure?
Objective response rate is the study’s stated Phase 2 objective. In general, an objective response rate is a proportion based on participants meeting defined tumor-response criteria. To interpret it, readers need the response definitions, the analysis population, the number of participants assessed, and the response estimate with an uncertainty measure. The registry record does not report these details or the Phase 2 response result. It is therefore not possible to assess the precision of the response estimate or the evidence for a difference between the randomized groups.
General statistical explanation: randomization can support a fair comparison by distributing measured and unmeasured baseline factors without systematic allocation, on average. It does not ensure that groups are identical, particularly when the available group sizes are limited. Open-label status means treatment assignment was not masked according to the record. Whether knowledge of assignment influenced assessment or other trial procedures cannot be determined from the information reported.
What can be inferred from the event counts?
The serious adverse-event listing reports affected participants and participants at risk for two Phase 1b groupings. These counts are descriptive. A count of participants affected is not the same as a count of distinct event episodes, and the record does not provide the event-level detail needed to distinguish those quantities. The listed percentages for the most frequent serious terms are 20.0% for Non-cardiac chest pain and 11.1% each for Femur fracture, Cancer pain, and Pericardial effusion malignant. Those percentages should be read as registry entries, not recalculated estimates.
General statistical explanation: adverse-event proportions can be difficult to compare when exposure duration, follow-up, or group composition differs. A participant may experience more than one event, and the number of events is not necessarily the number of affected participants. A comparison of raw counts also does not establish that treatment caused an event. The record does not report exposure-adjusted rates, a comparative safety analysis, or inferential uncertainty for these listings.
What does the sample-size planning description imply?
The registry’s planning description specifies a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the target effect expressed as a stated fraction of the observed effect. It says time-to-event planning uses a total event count based on the Schoenfeld approach, whereas other planning outputs are participants per arm. These are general planning assumptions, not evidence that the study had a particular power or that a treatment effect was observed.
General statistical explanation: a planning illustration asks how much information a future study might need under chosen assumptions. Its output depends on the assumed effect, variability, allocation, analysis method, and target power. If an observed effect is used as the starting point, planning around fractions of that effect explores sensitivity to smaller assumed effects; it does not validate the observed estimate. Such calculations are not observed power. The registry record does not report the study’s own sample-size justification, the target effect used in its original design, or a complete statistical analysis plan. No planning results or observed Phase 2 effect are reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The study description includes more than one objective: Phase 1b dose selection and Phase 2 evaluation of objective response rate. The registry identifies the Phase 1b recommended Phase 2 dose as the primary outcome listing, while the response-rate objective appears in the study summary. The record does not report how these objectives were ordered for formal inference, whether any additional outcomes were designated as confirmatory, or how multiplicity was addressed. A multiplicity adjustment or testing hierarchy is not reported in the registry record.
The registry record reports no analyses. It does not provide a statistical analysis plan, details of interim analyses, or the methods used to handle missing outcome data. It does not say how participants who discontinued, lacked an assessment, or were not evaluable would be treated in the Phase 2 response analysis. The dose rule refers to evaluable participants, but further rules defining evaluability are not reported in the registry record.
Analysis populations are described only in part. For Phase 1b safety, the stated analysis set included participants who received at least 1 dose of study drug in Phase 1b. The record does not report the analysis population for the Phase 2 response objective, whether it followed randomized assignment, or how participants were handled if treatment or assessment did not proceed as planned. These omissions matter because the population analyzed affects what the result represents.
Without results, analysis methods, and missing-data handling details, readers cannot assess the robustness of an outcome estimate or determine whether selective reporting could have influenced interpretation. The registry record does not explain why the study was terminated.
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 |
|---|---|---|---|
| Phase 1b: Dose Level 1 | 1 | 5 | 20.0% |
| Phase 1b: Dose Level 0 and Expansion Part | 3 | 9 | 33.3% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Phase 1b: Dose Level 1 | 2 of 5 |
| Phase 1b: Dose Level 0 and Expansion Part | 3 of 9 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Phase 1b: Dose Level 1 | 5 of 5 |
| Phase 1b: Dose Level 0 and Expansion Part | 9 of 9 |
Most frequent serious adverse event terms
| Event term | Organ system | Phase 1b: Dose Level 1 | Phase 1b: Dose Level 0 and Expansion Part |
|---|---|---|---|
| Non-cardiac chest pain | General disorders | 1 of 5 | 0 of 9 |
| Femur fracture | Injury, poisoning and procedural complications | 0 of 5 | 1 of 9 |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0 of 5 | 1 of 9 |
| Pericardial effusion malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0 of 5 | 1 of 9 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Phase 1b: Dose Level 1 | Phase 1b: Dose Level 0 and Expansion Part |
|---|---|---|---|
| Muscle spasms | Musculoskeletal and connective tissue disorders | 3 of 5 | 6 of 9 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 4 of 5 | 4 of 9 |
| Neutropenia | Blood and lymphatic system disorders | 1 of 5 | 5 of 9 |
| Fatigue | General disorders | 3 of 5 | 2 of 9 |
| Oedema peripheral | General disorders | 3 of 5 | 2 of 9 |
| Alopecia | Skin and subcutaneous tissue disorders | 4 of 5 | 1 of 9 |
| Constipation | Gastrointestinal disorders | 2 of 5 | 2 of 9 |
| Neutrophil count decreased | Investigations | 2 of 5 | 2 of 9 |
| Anaemia | Blood and lymphatic system disorders | 1 of 5 | 2 of 9 |
| Abdominal pain | Gastrointestinal disorders | 0 of 5 | 3 of 9 |
Serious events with the highest arm-level rate: non-cardiac chest pain (20.0%), femur fracture (11.1%), cancer pain (11.1%), pericardial effusion malignant (11.1%).
The serious adverse-event listing separates Phase 1b participants into Dose Level 1 and Dose Level 0 and Expansion Part. For Dose Level 1, it reports 1 affected participant among 5 at risk. For Dose Level 0 and Expansion Part, it reports 3 affected participants among 9 at risk. These are counts attached to the registry’s group labels, not a randomized comparison of serious-event risk across treatment strategies.
The record lists Non-cardiac chest pain at 20.0% and Femur fracture, Cancer pain, and Pericardial effusion malignant at 11.1% each among the top serious terms. The registry does not provide event-level narratives, timing, severity grades, exposure duration, or a causal assessment for these entries. A listed serious event should not be interpreted as necessarily caused by treatment. The record also lists deaths as 2 for Dose Level 1 and 3 for Dose Level 0 and Expansion Part, but does not report causes or treatment attribution.
General statistical explanation: serious adverse events and deaths are important safety outcomes, but interpretation depends on definitions, observation time, participant context, and completeness of reporting. Raw counts alone do not establish comparative safety or causation. The registry record does not report an adjusted or inferential safety analysis.
12. What the Result Does, and Does Not, Mean
The record establishes that the study was designed to investigate eribulin mesylate with PEGPH20 in HER2-negative metastatic breast cancer, with a Phase 1b dose-finding component and a Phase 2 objective response rate objective. It also establishes the planned eribulin-alone comparator in Phase 2 and gives the early-cycle dose-limiting-toxicity rule. These details explain what investigators intended to study; they do not show what the study found on its primary dose-selection outcome.
No recommended Phase 2 dose is reported in the available registry results. No Phase 2 objective response rate, comparative treatment effect, confidence interval, or hypothesis-test result is reported. Consequently, the record does not establish whether response differed between the combination and eribulin-alone groups, nor does it establish the size or precision of any difference. The design description cannot be used as a substitute for an outcome estimate.
The serious-event counts and listed serious terms offer limited descriptive safety information for the Phase 1b groupings. They do not demonstrate that a treatment caused an event, and they do not support a complete comparison of safety between the randomized Phase 2 groups. The separate death counts do not include an attribution or explanation in the registry record.
General statistical explanation: evidence about a treatment depends on the observed outcomes, the comparison being made, uncertainty around estimates, and the methods used to analyze the data. A planned objective states the question; it does not answer it. Likewise, absence of a posted result is not evidence that an outcome was favorable, unfavorable, or unchanged. The appropriate interpretation is limited to what the registry reports: design and aims, a predefined dose rule, and selected adverse-event counts. The reason for termination and the study’s full statistical analysis are not reported in the registry record.
13. Why This Trial Matters Statistically
This study is statistically notable because it combines an early dose-selection question with a randomized Phase 2 objective. Those stages require different forms of evidence. The Phase 1b question asks which combination dose satisfies a specified early toxicity criterion. The Phase 2 objective asks about objective response rate in a high-hyaluronan population, with eribulin mesylate alone listed as the comparator. Keeping these questions distinct prevents a dose-finding observation from being mistaken for evidence of a comparative response effect.
The record also illustrates why a registered objective and a posted result must be read separately. The study description is specific about the dose rule and the intended Phase 2 objective, but the registry record contains no reported analyses and no value for the primary dose-selection outcome. Without the outcome estimates and their uncertainty, readers cannot judge the strength or precision of evidence for either objective.
Safety counts are another reason statistical context matters. The record lists affected participants and serious-event terms, but not event-level detail, a comparative safety model, or an attribution of deaths. Descriptive counts can identify what was recorded, but they do not by themselves establish treatment causality or provide a complete group comparison.
Finally, the terminated status does not explain why the study ended. Statistical interpretation requires restraint when results and reasons for termination are absent. In this record, the most informative conclusions concern the study’s structure, the distinction between its aims, and the limits of the posted data—not an estimate of treatment benefit.
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.
The registry record does not report the primary dose-selection result, the Phase 2 response rate, or an analysis comparing the randomized Phase 2 groups. It also contains no posted analyses. As a result, no effect estimate or measure of precision can be evaluated for the stated efficacy objective. The recommended Phase 2 dose cannot be identified from the listed outcome definition alone.
The record does not report the reason for termination, the number of participants who entered each phase, or the extent to which planned assessments were completed. The listed enrollment of 25 does not identify how many participants contributed to each outcome. Further details on randomization, allocation ratio, eligibility assessment, follow-up, and analysis populations are not reported in the registry record.
For safety, the serious-event information is grouped by Phase 1b dose level and expansion part. It does not provide event-level descriptions, exposure time, severity grades, causality assessments, or comparative analyses. Deaths are listed, but their causes and relationship to treatment are not reported. The registry record therefore supports only a limited descriptive reading of these safety entries.
The record does not report response criteria, missing-data methods, an analysis plan, multiplicity procedures, interim analyses, or the study’s own sample-size justification. These omissions constrain evaluation of outcome definitions, potential bias, and the reliability of any conclusions. They also prevent assessment of whether the planned analyses were completed as intended.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Study of Eribulin Mesylate in Combination With PEGylated Recombinant Human Hyaluronidase (PEGPH20) Versus Eribulin Mesylate Alone in Subjects With Human Epidermal Growth Factor Receptor 2 (HER2)-Negative, High-Hyaluronan (HA) Metastatic Breast Cancer (MBC) — NCT02753595.
- Registry record last updated 2020-07-13; status last verified 2020-06.
- Results first posted 2020-07-13.
- 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.
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18. Record Summary
NCT02753595 is a randomized, open-label, multicenter, parallel Phase 1b/2 study of eribulin mesylate with PEGPH20 and eribulin mesylate alone in HER2-negative metastatic breast cancer. The registry lists enrollment of 25, status as terminated, a start date of 2016-07-13, and a primary completion date of 2019-08-16.
Phase 1b was intended to identify a recommended Phase 2 dose using a dose-limiting-toxicity rule during the first 21 days of treatment. Phase 2 was intended to evaluate objective response rate in participants with high-hyaluronan disease. The primary outcome listing concerns dose selection. No primary outcome value, Phase 2 response result, or analysis is reported in the registry record.
Serious adverse-event counts and selected serious terms are listed for two Phase 1b groupings. The record does not report the reason for termination, treatment attribution for deaths, or a comparative safety analysis.