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 Phase 1 Trial of PAN-301-1 (SNS-301) in Cancer Patients (NCT03120832), a na phase 1 study. The primary outcome is Safety Assessed by Development of Adverse Events and Dose-limiting Toxicity to Determine Maximum Tolerated Dose.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03120832 |
| Phase | Phase 1 |
| Condition | Prostate Cancer |
| Allocation | Not applicable (single group) |
| Design model | Sequential |
| Masking | None (open label) |
| Enrollment | 12 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Sensei Biotherapeutics, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
Patients with biochemically relapsed prostate cancer. The registry lists prostate cancer as the condition and describes cohorts of patients with biochemically relapsed disease. Enrollment is recorded as 12.
Intervention
PAN-301-1, also identified as SNS-301, is described as a HAAH-directed nanoparticle vaccine. It was administered intradermally in a dose-escalation scheme, with dosing every 21 days.
Comparator
No randomized control group is identified. Allocation is listed as not applicable, and the registry notes that the arms are not a like-for-like control comparison. The cohorts represent stages of dose escalation, not randomized treatment alternatives.
Primary question
The primary safety question was whether adverse events and dose-limiting toxicity occurred, with the stated aim of determining the maximum tolerated dose. The primary outcome was expressed as a count of participants and assessed through the 21 day interval after the first vaccine dose. A result identifying a maximum tolerated dose is not reported in the registry record.
This is a phase 1, open-label study. Its clinical question is therefore chiefly about safety during early evaluation and dose escalation, rather than a comparison of vaccine outcomes against a control. The posted safety counts distinguish serious adverse events from other adverse events within each cohort. They describe events recorded in the registry; they do not establish whether an event was caused by the vaccine. The record also lists administration-site reactions and abnormal laboratory values among the safety topics assessed as secondary outcomes. Those topics do not substitute for a posted analysis of the primary safety endpoint.
The registry describes PAN-301-1 as a HAAH-directed nanoparticle vaccine and identifies the route of administration as intradermal. It does not report a separate clinical efficacy question or an efficacy result in the registry record for this analysis. Consequently, interpretation should stay focused on the stated safety objective and the information actually recorded for the cohorts.
3. Trial Design
The registry identifies this study as phase 1 and open label, with no masking. Its model is listed as sequential, and its brief description calls it an open-label, parallel-design study. It also describes a fixed dose-escalation schema in cohorts, with administration every 21 days. These design labels are not fully aligned: “sequential” appears as the model, while “parallel design” appears in the brief description. The record does not explain the relationship between those labels, so the design is best described with that qualification rather than treating the terms as interchangeable.
The intervention was PAN-301-1 (SNS-301), a biological intervention administered intradermally. The arm description identifies three cohorts in a dose-escalation schema. The posted safety data are presented by Cohort 1, Cohort 2, and Cohort 3. The dose amounts and the rules for moving between dose levels are not reported in the registry record. The stated interval of every 21 days describes the dosing schedule; it should not be interpreted as evidence about how long each participant was followed overall.
The registry lists enrollment as 12, study start as 2016-12, primary completion as 2018-12, and status as completed. The sponsor is Sensei Biotherapeutics, Inc. These registry fields describe study administration and timing; they do not establish that every planned analysis or outcome was posted.
Allocation is listed as not applicable. The registry explicitly cautions that this is not a randomized comparison and that the arms are not a like-for-like control comparison. Therefore, differences in observed counts across cohorts cannot be interpreted as randomized evidence that one dose level caused more or fewer events than another. Cohorts in a dose-escalation study have a distinct role from treatment and control groups in a comparative trial. The registry record does not report the protocol details needed to explain cohort assignment, escalation decisions, or whether any participants received different follow-up.
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 | Cohort 1 | Cohort 2 | Cohort 3 |
|---|---|---|---|
| STARTED | 3 | 3 | 6 |
| COMPLETED | 3 | 3 | 6 |
| NOT COMPLETED | 0 | 0 | 0 |
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 | Cohort 1 | Cohort 2 | Cohort 3 | Total |
|---|---|---|---|---|---|
| Participants analysed | 3 | 3 | 6 | 12 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 | 1 | 1 | 2 |
| Age, Categorical: >=65 years | Participants | 3 | 2 | 5 | 10 |
| Age, Continuous | years | 67 (SD 1.73) | 67 (SD 6.24) | 72.8 (SD 9.62) | 69.9 (SD 7.68) |
| Sex: Female, Male: Female | Participants | 0 | 0 | 0 | 0 |
| Sex: Female, Male: Male | Participants | 3 | 3 | 6 | 12 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 2 | 0 | 0 | 2 |
| Race (NIH/OMB): White | Participants | 1 | 3 | 6 | 10 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
| Region of Enrollment: United States | participants | 3 | 3 | 6 | 12 |
6. Primary Endpoint
The registry lists the primary outcome as Safety Assessed by Development of Adverse Events and Dose-limiting Toxicity to Determine Maximum Tolerated Dose, measured over Through the 21 day interval after the first dose of vaccine.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is described as safety assessed through development of adverse events and dose-limiting toxicity, with the aim of determining the maximum tolerated dose. Its unit is participants, and its measure is a count of participants. The specified assessment period is through the 21 day interval after the first dose of vaccine. In practical terms, this endpoint is intended to record how many participants meet the stated safety criteria during that period, rather than to measure a change in a continuous clinical quantity.
In general, early-phase dose-escalation studies use safety observations to guide decisions about dose levels and tolerability. A dose-limiting toxicity is a protocol-defined safety event; the definition and decision rules for this trial are not reported in the registry record. The endpoint title refers to a maximum tolerated dose, but the registry entries do not state the dose levels, the criteria used to select that dose, or a resulting dose determination.
The registry lists the primary endpoint description without a separate detailed definition of the event criteria or analysis population. It records two outcome measures overall, but the registry entries do not provide a full breakdown of those measures or a posted primary endpoint analysis. Thus, the endpoint can be described by its stated purpose and time frame, but not by an unreported operational definition or a numerical primary-outcome result. The adverse-event counts posted by cohort are relevant safety information, but they should not automatically be treated as a complete result for the primary endpoint or as the final determination of a maximum tolerated dose.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted adverse-event counts are separated by cohort and by serious versus other adverse events. In Cohort 1, the record lists 3 participants at risk for serious adverse events and 1 affected; for other adverse events, it lists 3 at risk and 3 affected. In Cohort 2, it lists 3 at risk and 0 affected for serious adverse events, and 3 at risk and 2 affected for other adverse events. In Cohort 3, it lists 6 at risk and 1 affected for serious adverse events, and 6 at risk and 5 affected for other adverse events. These are counts, not comparative effect estimates.
The registry also records deaths as 0 for each cohort. These entries describe the posted death counts in the corresponding groups; they do not supply a broader mortality analysis or establish the cause of any event. The serious adverse-event terms listed include “Vertigo positional” at 33.3% and “Demyelination” at 16.7%. The registry record does not state the denominators or detailed calculation behind those percentages in the registry record for this analysis, so they should be read as the listed percentages rather than recalculated or interpreted as participant-level risks.
There is no randomized control group, and the cohort groups are not described as like-for-like comparators. The counts therefore support a descriptive reading only. They cannot establish that dose escalation caused a difference in event frequency across cohorts. The small cohort counts also mean that each observed participant corresponds to a substantial part of the group’s recorded count, limiting the precision of any informal comparison. No inferential analysis, confidence interval, or hypothesis test is reported in the registry record.
The primary outcome’s stated objective includes dose-limiting toxicity and determination of a maximum tolerated dose. However, the registry entries do not give a numerical count of participants meeting a defined dose-limiting toxicity criterion, nor do they report a maximum tolerated dose determination. The adverse-event counts should not be substituted for those missing results: the endpoint criteria may be more specific than the broad adverse-event categories, and those criteria are not reported in the registry record.
Interpretation is further constrained by the difference between an outcome being registered and an analysis being posted. The record lists two outcome measures but reports zero analyses. Accordingly, the safety counts are descriptive observations, while a formal analysis of the primary endpoint is not available in the registry record. This is not evidence that no analysis was performed elsewhere; it means the registry entries do not include one. No conclusion about efficacy or comparative benefit follows from these safety counts.
9. Statistical Methods Explained
Statistical interpretation should begin with the kind of quantity being reported. The primary endpoint is specified as a count of participants, and the adverse-event summaries are also expressed as counts of participants affected. Such counts tell the reader how many people in a cohort were recorded as having an event category. They do not, by themselves, convey event severity, duration, recurrence, or causal attribution. Those details require definitions and summaries that are not reported in the registry record.
What does a count of participants represent?
A participant count is a discrete outcome: each person is classified according to whether the specified event criterion was met during the relevant assessment period. For the primary endpoint, the stated period is through the 21 day interval after the first vaccine dose. For the posted adverse-event group summaries, the record supplies the number at risk and the number affected for each cohort and category. These are useful descriptive quantities, but the registry entries do not define every rule used to decide who was at risk or affected. They also do not report whether participants could contribute to more than one event category.
In general, a proportion can be formed by relating the number affected to the number assessed under a clearly defined outcome and follow-up scheme. That is a general statistical concept, not a new result for this study. The registry entries include several counts and two percentages for serious terms, but do not provide all the denominator and event-definition details needed to construct a uniform participant-level proportion for every result. No additional proportions should be inferred from the counts in the explanatory text.
Why does the design matter for comparisons?
In general, random allocation can help make treatment groups comparable with respect to measured and unmeasured characteristics. This study is not identified as randomized: allocation is listed as not applicable, and the registry cautions that the arms are not a like-for-like control comparison. The groups are cohorts in a dose-escalation study. A difference in their counts might reflect cohort composition, the dose-escalation process, or other factors, as well as any relationship to dose. The registry record does not report enough information to separate those possibilities. Therefore, cohort counts should be described rather than treated as causal estimates.
The model field says sequential, while the brief description says parallel design. General statistical interpretation depends on knowing whether participants are assigned successively to cohorts, concurrently to groups, or under another structure. Because the registry does not reconcile its two labels, the explanation should not assume a more specific allocation process than the record states. The registry entries do establish an open-label study with three dose-escalation cohorts and no masking.
What would uncertainty measures add?
In general, a confidence interval expresses the uncertainty around an estimated quantity under specified statistical assumptions. For a count-based safety endpoint, an interval can help show how imprecise an estimated event frequency may be, especially when cohorts are limited in size. A confidence interval is not a guarantee that the true value lies within its limits, and its interpretation depends on the method and assumptions used. No confidence intervals or method for calculating them are reported in the registry record, so none can be described as a trial result.
In general, hypothesis tests address whether observed data are compatible with a specified statistical null hypothesis under a chosen model. A p-value is not the probability that a treatment works or that the null hypothesis is true. This record reports zero analyses, and no inferential test or p-value is included in the registry record. There is therefore no posted hypothesis-test result to interpret. The absence of a reported test does not show that no analysis occurred outside the registry.
How should sample-size illustrations be understood?
General sample-size planning asks how much information a future study may need to detect a specified effect under chosen assumptions. The stated planning assumptions describe a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is a stated fraction of the observed effect. These are planning assumptions, not evidence that this phase 1 trial was designed using those assumptions. The record does not report its own sample-size justification. It also cautions that the trial is not a randomized comparison, so a two-arm equal-allocation illustration does not describe the actual cohort structure.
Any sample-size illustration based on an observed effect is conditional on that effect estimate and the assumptions used for planning. It is not observed power, and it does not establish that the trial could reliably answer a clinical question. The registry entries do not supply a numerical effect estimate or a specific illustration result for discussion. No planning value should be read as an observed trial outcome. Likewise, such an illustration cannot repair the absence of a posted primary endpoint analysis.
What do the posted safety summaries establish?
They establish the cohort-specific counts recorded for serious and other adverse events and the listed deaths. In general, descriptive safety summaries are important in early-phase research because they show what was recorded and can inform further evaluation. But counts alone do not establish causality, comparative risk, or a maximum tolerated dose. The endpoint’s dose-limiting toxicity definition, escalation criteria, participant-level event details, and analysis methods are not reported in the registry record. Statistical interpretation should therefore remain close to the descriptive summaries and avoid conclusions that require those missing details.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists two outcome measures and zero analyses. The primary outcome is framed around adverse events and dose-limiting toxicity for determining a maximum tolerated dose, while a secondary outcome concerns safety assessed by administration-site reactions, abnormal laboratory values, and/or adverse events. The registry entries do not provide a complete outcome-by-outcome analysis or explain how the listed outcomes relate to the posted cohort counts.
In general, multiplicity arises when several outcomes, comparisons, or statistical tests are examined. Testing many hypotheses can increase the chance of at least one apparently noteworthy result unless the analysis plan addresses that issue. The registry record does not report a multiplicity strategy, a hierarchy of outcomes, or an analysis plan. It is therefore not possible to determine whether any adjustment was planned or needed for analyses not posted in the record. No inference about the presence or absence of such a plan should be made.
Missing-data methods and analysis populations are also not reported in the registry record. The adverse-event summaries include numbers at risk for each cohort and category, but the registry entries do not explain how missing observations, withdrawals, or incomplete follow-up were handled. They do not identify a safety population or provide participant-level follow-up details. The fact that the record lists enrollment as 12 does not establish how many participants were included in each possible analysis beyond the cohort counts explicitly reported.
Without these details, readers cannot assess whether the posted counts include all eligible participants, whether follow-up was complete, or whether any analyses used a different population. This limitation is particularly relevant when interpreting a short specified primary assessment period alongside safety summaries whose follow-up rules are not fully described. The registry entries support reporting the counts as recorded, but not filling in the missing analysis procedures.
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 |
|---|---|---|---|
| Cohort 1 | 1 | 3 | 33.3% |
| Cohort 2 | 0 | 3 | 0.0% |
| Cohort 3 | 1 | 6 | 16.7% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Cohort 1 | 0 of 3 |
| Cohort 2 | 0 of 3 |
| Cohort 3 | 0 of 6 |
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 |
|---|---|
| Cohort 1 | 3 of 3 |
| Cohort 2 | 2 of 3 |
| Cohort 3 | 5 of 6 |
Most frequent serious adverse event terms
| Event term | Organ system | Cohort 1 | Cohort 2 | Cohort 3 |
|---|---|---|---|---|
| Vertigo positional | Ear and labyrinth disorders | 1 of 3 | 0 of 3 | 0 of 6 |
| Demyelination | Nervous system disorders | 0 of 3 | 0 of 3 | 1 of 6 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Cohort 1 | Cohort 2 | Cohort 3 |
|---|---|---|---|---|
| Hypertension | Cardiac disorders | 0 of 3 | 1 of 3 | 2 of 6 |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | 0 of 3 | 1 of 3 | 1 of 6 |
| Fatigue | General disorders | 0 of 3 | 1 of 3 | 0 of 6 |
| Injection site erythema | Immune system disorders | 0 of 3 | 0 of 3 | 1 of 6 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 1 of 3 | 0 of 3 | 0 of 6 |
| Alanine aminotransferase increased | Investigations | 0 of 3 | 1 of 3 | 0 of 6 |
| Upper respiratory tract infection | Infections and infestations | 1 of 3 | 0 of 3 | 0 of 6 |
| Herpes Zoster | Infections and infestations | 0 of 3 | 0 of 3 | 1 of 6 |
| Decreased appetite | Metabolism and nutrition disorders | 1 of 3 | 0 of 3 | 0 of 6 |
| Insomnia | Psychiatric disorders | 0 of 3 | 0 of 3 | 1 of 6 |
Serious events with the highest arm-level rate: vertigo positional (33.3%), demyelination (16.7%).
The serious adverse-event summaries report, by cohort, the number at risk and the number affected. Cohort 1 lists 3 at risk and 1 affected; Cohort 2 lists 3 at risk and 0 affected; Cohort 3 lists 6 at risk and 1 affected. The corresponding other-adverse-event counts are 3 at risk and 3 affected in Cohort 1, 3 at risk and 2 affected in Cohort 2, and 6 at risk and 5 affected in Cohort 3. Deaths are recorded as 0 in each cohort.
These figures are descriptive. “Serious” is a category distinct from the broader other-adverse-event category in the registry summaries; it should not be assumed that the latter represents events that were clinically unimportant. The registry entries do not provide detailed event definitions, participant-level narratives, attribution to study treatment, or information about whether one participant could have multiple events. The counts therefore do not show how many total events occurred or establish that the vaccine caused them.
The listed serious terms are Vertigo positional at 33.3% and Demyelination at 16.7%. The denominator and calculation details for these percentages are not reported in the registry record. They should not be converted into participant counts or treated as directly comparable cohort risks. The posted information is useful for describing what the registry records, but it does not replace a detailed safety analysis or the missing primary endpoint analysis.
12. What the Result Does, and Does Not, Mean
The registry record describes an open-label phase 1 study of PAN-301-1 (SNS-301) in patients with biochemically relapsed prostate cancer. It records intradermal administration in three dose-escalation cohorts and gives adverse-event counts by cohort. Those counts document the safety observations posted in the registry, including serious events, other events, and deaths recorded as 0 for each cohort.
The record does not report a formal analysis of the primary safety endpoint. Although the endpoint is intended to assess adverse events and dose-limiting toxicity through the 21 day interval after the first dose and to determine a maximum tolerated dose, no result for that determination is included in the registry record. The listed adverse-event counts cannot by themselves establish whether dose-limiting toxicity criteria were met. The operational definition and escalation decision rules are not reported in the registry record.
The cohort summaries also do not support a controlled comparison. The study is not randomized, and the registry cautions that the arms are not like-for-like controls. Differences in counts across cohorts should not be interpreted as evidence that one dose level caused more or fewer events. No confidence intervals, hypothesis tests, or comparative effect estimates are reported.
These results do not answer a treatment-efficacy question. The registry entries describe safety objectives and observations, but do not report an efficacy outcome. Nor does the absence of a posted analysis establish that no analysis was conducted elsewhere. The defensible interpretation is limited to the study design and descriptive data present in the registry record. Missing details about endpoint definitions, follow-up, analysis populations, and dose levels further restrict interpretation.
13. Why This Trial Matters Statistically
This trial illustrates a central statistical distinction in early-phase research: describing safety observations is not the same as estimating a comparative treatment effect. The registry reports cohort-specific counts during a dose-escalation study, but identifies no randomized control group. That means the counts can inform a descriptive account of what was recorded, while offering no like-for-like basis for attributing differences between cohorts to dose alone.
The primary endpoint also shows why an endpoint title is not a substitute for a result. The stated objective is to assess adverse events and dose-limiting toxicity to determine a maximum tolerated dose. To interpret such a determination statistically, readers would need the operational toxicity criteria, dose levels, escalation rules, and analysis population. Those details and a numerical determination are not reported in the registry record. Broad adverse-event counts are relevant context, but do not establish the primary endpoint result.
The record’s design labels warrant attention as well. It lists a sequential model and describes a parallel design in the brief summary. Since no explanation reconciles those labels, statistical readers should preserve the distinction rather than infer a precise assignment structure. This is an example of how registry terminology can affect interpretation even before considering results.
Finally, zero analyses are reported despite two listed outcome measures. This does not prove that no analysis exists outside the registry, but it limits what can be concluded from the registry record itself. The trial is therefore useful for illustrating the value of separating design descriptions, outcome definitions, descriptive safety observations, and formal analyses. Keeping those elements distinct prevents a posted count from being mistaken for a causal conclusion or a completed primary-endpoint assessment.
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 most direct limitation is the lack of a posted primary endpoint analysis. The endpoint concerns adverse events and dose-limiting toxicity through the 21 day interval after the first vaccine dose, but no numerical result identifying a maximum tolerated dose is reported. The registry lists two outcome measures and zero analyses. It is not possible to tell from these registry entries whether an analysis was completed outside the registry.
The cohort structure also limits comparison. Allocation is listed as not applicable, and the registry explicitly says the arms are not a like-for-like control comparison. The observed counts cannot be treated as randomized evidence of a dose effect. The registry’s sequential model label and its brief description of a parallel design are not reconciled. In addition, dose levels and cohort assignment rules are not reported in the registry record.
Safety definitions and analysis details are incomplete in the registry record. The record does not specify the operational definition of dose-limiting toxicity, the rules for escalation, how missing observations were handled, or the analysis population. It does not report participant-level event details or clarify how repeated or overlapping events were represented. The denominators and calculation details for the listed serious-event percentages are also not reported in the registry record.
Enrollment is recorded as 12, and the posted cohort counts are limited in size. In general, counts from small groups provide limited precision, and single observations can have a visible effect on descriptive summaries. No confidence intervals or inferential analyses are posted to quantify uncertainty. The registry lists the study as completed, but completion status does not fill these gaps or establish that all analyses are available. These limitations call for a cautious, descriptive reading rather than a causal or definitive safety conclusion.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Phase 1 Trial of PAN-301-1 (SNS-301) in Cancer Patients — NCT03120832.
- Registry record last updated 2021-11-12; status last verified 2021-10.
- Results first posted 2021-11-12.
- 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
NCT03120832 is a completed phase 1, open-label study sponsored by Sensei Biotherapeutics, Inc. The registry lists a study start of 2016-12, primary completion of 2018-12, and enrollment of 12. It concerns PAN-301-1 (SNS-301), a HAAH-directed nanoparticle vaccine administered intradermally to patients with biochemically relapsed prostate cancer in three dose-escalation cohorts, with dosing every 21 days.
The primary endpoint concerns adverse events and dose-limiting toxicity, assessed through the 21 day interval after the first dose, with the stated aim of determining a maximum tolerated dose. Cohort-level counts of serious and other adverse events are posted, along with deaths recorded as 0 in each cohort. The registry reports two outcome measures and zero analyses. It does not report a primary endpoint analysis, a maximum tolerated dose determination, dose levels, or detailed analysis methods. Because the study is not randomized and its cohorts are not like-for-like controls, the safety counts are descriptive rather than comparative evidence.