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 Talimogene Laherparepvec in Patients With Unresectable Pancreatic Cancer (NCT00402025), a na phase 1 study. The primary outcome is Number of Participants With Adverse Events.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00402025 |
| Phase | Phase 1 |
| Condition | Pancreatic Cancer |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 17 |
| Arms in the primary outcome | n/a |
| Lead sponsor | BioVex Limited |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned participants with pancreatic cancer that could not be removed by surgery. The registry record lists the condition as pancreatic cancer and identifies the primary endpoint population as the ITT population. It does not provide further eligibility criteria or a detailed description of participants’ disease characteristics.
Intervention
Participants received talimogene laherparepvec by direct injection into the tumor. The treatment plan described 3 doses, administered 3 weeks apart. At the investigator’s discretion, treatment could continue beyond the third dose until week 15, with at least 3 weeks between doses. The registry record lists three dose-level groups.
Comparator
There was no reported concurrent control group. The record identifies a single-group model and no allocation method, and it notes that the dose-level groups are not a like-for-like control comparison. Differences between those groups therefore should not be read as randomized comparative effects.
Primary question
The primary endpoint was the number of participants with adverse events, assessed from the first dose until 30 days after the last dose. The registry record also lists changes in injected-tumor size, overall objective response, and pain intensity as secondary outcomes. It does not report results or analyses for those secondary outcomes. The central question supported by the posted data is therefore how many participants in each dose-level group were recorded as having serious or other adverse events, not whether the treatment was more effective than an alternative.
3. Trial Design
This was a completed phase 1 study of talimogene laherparepvec in pancreatic cancer. The registry record describes the model as single group, allocation as not applicable, and masking as none. Enrollment was 17. The study began in 2006-11 and reached primary completion in 2008-01. The sponsor was BioVex Limited.
The intervention was a biological treatment given by direct injection. Participants received 3 planned doses 3 weeks apart. The investigator could decide to continue treatment beyond the third dose until week 15, provided doses were at least 3 weeks apart. The posted safety results are organized into three groups defined by talimogene laherparepvec concentration: 10⁴/ 10⁵ PFU/mL, 10⁵ / 10⁶ PFU/mL, and 10⁶ / 10⁷ PFU/mL. The registry record does not describe random assignment to these groups, so their results are not a randomized dose comparison.
The primary outcome was the number of participants with adverse events. Its stated assessment period ran from the first dose until 30 days after the last dose. The record notes median treatment durations of 44.0 days, 22.0 days, and 11.5 days in each group respectively. Secondary outcomes included change from baseline in the sum of longest diameters of injected tumors, number of participants with an overall objective response, and change from baseline in pain intensity.
The record lists six outcome measures but zero analyses. It does not report the study’s statistical analysis plan, allocation procedures, eligibility criteria, or reasons for the treatment duration differences. Those omissions limit how fully the study conduct and outcome comparisons can be evaluated.
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 | Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL | Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL | Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL |
|---|---|---|---|
| STARTED | 3 | 4 | 10 |
| COMPLETED | 1 | 1 | 0 |
| NOT COMPLETED | 2 | 3 | 10 |
Reasons for not completing this period:
| Reason | Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL | Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL | Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL |
|---|---|---|---|
| Adverse Event | 0 | 0 | 2 |
| Death | 0 | 1 | 5 |
| Disease Progression | 1 | 1 | 2 |
| Physician Decision | 1 | 1 | 0 |
| Participant Decision | 0 | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: ITT population
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 Intention-to-Treat (ITT) population included all participants who received at least 1 dose of talimogene laherparepvec.
| Characteristic | Unit | Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL | Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL | Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL | Total |
|---|---|---|---|---|---|
| Participants analysed | 3 | 4 | 10 | 17 | |
| Age, Continuous | years | 54.7 (SD 10.97) | 63.8 (SD 10.21) | 50.8 (SD 6.68) | 54.5 (SD 9.47) |
| Sex: Female, Male: Female | Participants | 0 | 3 | 3 | 6 |
| Sex: Female, Male: Male | Participants | 3 | 1 | 7 | 11 |
| Race/Ethnicity, Customized: White | participants | 2 | 3 | 8 | 13 |
| Race/Ethnicity, Customized: Black | participants | 1 | 1 | 0 | 2 |
| Race/Ethnicity, Customized: Other | participants | 0 | 0 | 2 | 2 |
| Eastern Cooperative Oncology Group (ECOG) Performance Status: 0 (Fully active) | participants | 1 | 0 | 2 | 3 |
| Eastern Cooperative Oncology Group (ECOG) Performance Status: 1 (Restrictive but ambulatory) | participants | 1 | 3 | 7 | 11 |
| Eastern Cooperative Oncology Group (ECOG) Performance Status: 2 (Ambulatory but unable to work) | participants | 1 | 1 | 1 | 3 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With Adverse Events, measured over From first dose of talimogene laherparepvec until 30 days after the last dose; the median duration of treatment was 44.0 days, 22.0 days, and 11.5 days in each group respectively..
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants with adverse events. The registry record identifies the ITT population and specifies that events were assessed from the first dose of talimogene laherparepvec until 30 days after the last dose. It defines a serious adverse event as an untoward medical occurrence that, at any dose, leads to outcomes such as death, a life-threatening event, hospitalization or prolonged hospitalization, persistent or significant disability, a congenital anomaly or birth defect, or another important medical event requiring intervention or potentially jeopardizing the participant.
Counting participants with events is a binary-outcome approach: for each participant, the relevant question is whether an event was recorded during the assessment period. The posted safety figures distinguish participants affected by serious events from those affected by other events in each dose-level group. These counts describe how many participants were recorded as affected; they do not by themselves show the total number of event episodes, the severity of every event, or whether an event was caused by treatment.
Safety endpoints are used to characterize adverse experiences during and after treatment, particularly in an early-phase study. They can describe what was observed in the enrolled participants over the specified follow-up period. They do not establish comparative safety without a suitable comparator, and they cannot determine treatment effects on tumor response or pain. The registry record does not report a statistical comparison or a causal assessment of the adverse events.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted safety counts vary across the three dose-level groups. In the 10⁴/ 10⁵ PFU/mL group, serious adverse events affected 2 of 3 participants and other adverse events affected 3 of 3. In the 10⁵ / 10⁶ PFU/mL group, serious adverse events affected 3 of 4 participants and other adverse events affected 4 of 4. In the 10⁶ / 10⁷ PFU/mL group, serious adverse events affected 9 of 10 participants and other adverse events affected 10 of 10. These are descriptive counts from the registry record, not estimates from a randomized comparison.
The denominators are small, so each participant’s recorded status has a substantial influence on the group count. A count near the group denominator indicates that most or all participants in that group were recorded as affected during the defined observation period. It does not indicate how many event episodes occurred, how long events lasted, or whether the events were judged related to treatment. The registry record’s serious-event definition describes qualifying medical consequences; the adverse-event counts should not be interpreted as a complete account of each participant’s clinical course.
The numerical pattern across groups should not be interpreted as evidence of a dose-related increase or decrease. The record does not report random allocation, and it explicitly cautions that the groups are not a like-for-like control comparison. It also does not report baseline characteristics or explanations for differences in the groups’ treatment duration. Without those details, observed group differences could reflect differences in participants, exposure, follow-up, or other factors, and cannot be attributed to concentration.
The primary endpoint’s timeframe includes treatment and follow-up through 30 days after the last dose. The record gives median treatment durations of 44.0 days, 22.0 days, and 11.5 days in each group respectively. The record does not explain why these durations differed, and the duration figures do not establish how long every participant was observed. Therefore, the group counts should be read within the endpoint’s stated observation window, not as rates adjusted for exposure time.
The record lists secondary outcomes concerning injected-tumor size, objective response, and pain intensity, but their results are not reported in the registry record. No efficacy conclusion can be drawn from the safety counts. The registry record lists zero analyses, and it does not report statistical tests, confidence intervals, or an analysis plan. The available results are therefore useful as a descriptive account of recorded adverse events in this study, but they do not quantify comparative treatment effects or the precision of those effects.
9. Statistical Methods Explained
The posted results are counts of participants affected, grouped by the concentration category recorded for talimogene laherparepvec. For each category, the record gives the number at risk and the number affected for serious adverse events and for other adverse events. Reading these as participant counts preserves the endpoint’s stated meaning. They are not counts of event episodes: one participant may have experienced more than one event, but those episode totals are not reported in the registry record.
What does a participant count show?
A binary endpoint classifies each participant according to whether the event of interest occurred during the defined period. In general, this is a direct way to describe the proportion of participants who experienced an event, provided the denominator and outcome definition are clear. The posted results give affected counts and group denominators; they do not provide confidence intervals or a formal statistical comparison. No additional percentages or uncertainty measures should be inferred from the counts when interpreting the registry record.
These counts also depend on how events were identified, recorded, and followed. The record provides a definition for serious adverse events and an assessment window from the first dose until 30 days after the last dose. It does not provide a detailed event-collection procedure, adjudication process, or the event definition used for the separate other-event category. It also does not report whether every participant completed the full observation window.
Why does the study structure matter?
The registry record describes a single-group study with no masking and no allocation method. The three reported concentration categories do not constitute a randomized control comparison. A statistical comparison between nonrandomized groups would be vulnerable to confounding: participants could differ in clinical characteristics, treatment exposure, or follow-up for reasons the record does not report. General statistical principle: an association between group membership and an outcome does not establish that the group assignment caused the difference.
The record notes median treatment durations of 44.0 days, 22.0 days, and 11.5 days in each group respectively. This is relevant context for interpreting event counts because the time participants were exposed to treatment may differ. The stated endpoint window extends through 30 days after the last dose, but the record does not provide person-time or an exposure-adjusted event analysis. General statistical principle: when observation or exposure time differs, raw participant counts do not describe event frequency per unit of time. That limitation cannot be resolved from the posted counts alone.
What would an interval estimate add?
General statistical explanation: a confidence interval describes the range of effect estimates that are reasonably compatible with the observed data under a specified statistical model. It conveys precision, not the probability that a particular treatment effect is true. With small groups, estimates of binary outcomes are generally imprecise, and intervals can be wide. The registry record does not report confidence intervals for these safety counts, so the precision of a group-level event proportion is not quantified in the posted results.
The record also does not report hypothesis tests or a model for comparing groups. A p-value, if available, would address compatibility with a specified null hypothesis under its assumptions; it would not measure clinical importance or establish causality. No p-value or comparative effect estimate should be inferred from the counts. General statistical principle: estimates and their uncertainty are usually more informative than a significance label, especially when sample sizes are limited and comparison groups are not randomized.
How should planning illustrations be understood?
The sample-size assumptions describe a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The effect to detect is defined as a stated fraction of the observed effect. Those assumptions are not a description of this study’s design: the registry record describes a single-group model and does not report a two-arm randomized comparison. Any sample-size illustration is a hypothetical planning exercise, not observed power and not evidence that the present study was designed to detect a particular difference.
General statistical principle: power is a design property conditional on assumptions about the effect, variability, outcome distribution, and analysis. A calculation using an effect observed in a small study can be especially uncertain, because that observed effect may not represent the underlying effect. Planning calculations do not repair the lack of a concurrent comparator or create evidence of efficacy. The registry record does not report a sample-size justification for the trial itself.
For the binary safety outcome, the counts remain descriptive unless a defined analysis specifies the target comparison, population, handling of missing outcomes, and uncertainty estimation. The registry record does not report those details or an analysis plan. General statistical principle: when event probabilities vary across participants more than a simple model assumes, over-dispersion can make conventional uncertainty estimates too narrow. No over-dispersion model is reported for these data, and the posted participant counts alone do not show whether such modeling would be appropriate.
10. Multiplicity, Missing Data and Analysis Populations
The record lists six outcome measures, including the primary count of participants with adverse events and secondary measures concerning injected-tumor size, objective response, and pain intensity. It does not report a multiplicity strategy for assessing several outcomes. In general, when many outcomes or comparisons are tested, the chance of at least one apparently unusual result can increase. Whether and how that issue was addressed is not reported in the registry record. The record lists zero analyses, so no multiplicity-adjusted or unadjusted inferential results are available to interpret.
The primary endpoint identifies the ITT population. However, the registry record does not explain how that population was defined for analysis, whether any participants lacked outcome data, or how missing observations were handled. It also does not report withdrawals, exclusions from the analysis population, or completeness of follow-up. These details matter because a participant without recorded outcome information cannot automatically be treated as having no adverse event.
The posted group counts include denominators and affected participants for serious and other adverse events. They do not describe missing-data assumptions, imputation, sensitivity analyses, or whether the same participants contributed to every outcome. The listed secondary outcomes have no reported results in the registry record. Thus, interpretation is limited to the reported safety counts and should not imply complete ascertainment or a prespecified strategy for selecting among outcomes.
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 |
|---|---|---|---|
| Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL | 2 | 3 | 66.7% |
| Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL | 3 | 4 | 75.0% |
| Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL | 9 | 10 | 90.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL | 3 of 3 |
| Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL | 4 of 4 |
| Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL | 10 of 10 |
Most frequent serious adverse event terms
| Event term | Organ system | Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL | Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL | Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL |
|---|---|---|---|---|
| ASCITES | Gastrointestinal disorders | 1 of 3 | 0 of 4 | 3 of 10 |
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | 0 of 3 | 0 of 4 | 3 of 10 |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | 0 of 3 | 1 of 4 | 2 of 10 |
| ABDOMINAL PAIN | Gastrointestinal disorders | 0 of 3 | 0 of 4 | 2 of 10 |
| DEHYDRATION | Metabolism and nutrition disorders | 1 of 3 | 0 of 4 | 1 of 10 |
| MENTAL STATUS CHANGES | Psychiatric disorders | 0 of 3 | 1 of 4 | 1 of 10 |
| ANAEMIA | Blood and lymphatic system disorders | 0 of 3 | 0 of 4 | 1 of 10 |
| LEUKOCYTOSIS | Blood and lymphatic system disorders | 0 of 3 | 0 of 4 | 1 of 10 |
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | 0 of 3 | 0 of 4 | 1 of 10 |
| BRADYCARDIA | Cardiac disorders | 0 of 3 | 0 of 4 | 1 of 10 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL | Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL | Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL |
|---|---|---|---|---|
| ABDOMINAL PAIN | Gastrointestinal disorders | 0 of 3 | 0 of 4 | 6 of 10 |
| ASCITES | Gastrointestinal disorders | 1 of 3 | 0 of 4 | 5 of 10 |
| CONSTIPATION | Gastrointestinal disorders | 0 of 3 | 1 of 4 | 5 of 10 |
| NAUSEA | Gastrointestinal disorders | 2 of 3 | 0 of 4 | 4 of 10 |
| DEHYDRATION | Metabolism and nutrition disorders | 2 of 3 | 0 of 4 | 4 of 10 |
| ANAEMIA | Blood and lymphatic system disorders | 0 of 3 | 2 of 4 | 3 of 10 |
| VOMITING | Gastrointestinal disorders | 1 of 3 | 1 of 4 | 3 of 10 |
| DIARRHOEA | Gastrointestinal disorders | 2 of 3 | 0 of 4 | 2 of 10 |
| PYREXIA | General disorders | 0 of 3 | 1 of 4 | 3 of 10 |
| ABDOMINAL DISTENSION | Gastrointestinal disorders | 0 of 3 | 0 of 4 | 3 of 10 |
Serious events with the highest arm-level rate: ascites (33.3%), bacteraemia (33.3%), dehydration (33.3%), general physical health deterioration (30.0%), disease progression (25.0%).
The serious adverse event figures count participants affected within each concentration group: 2 of 3 in the 10⁴/ 10⁵ PFU/mL group, 3 of 4 in the 10⁵ / 10⁶ PFU/mL group, and 9 of 10 in the 10⁶ / 10⁷ PFU/mL group. The corresponding counts for other adverse events are 3 of 3, 4 of 4, and 10 of 10. These numbers describe participants, not the total number of event episodes.
The registry record defines a serious adverse event by the medical consequences it may entail, including death, life-threatening events, hospitalization, significant disability, congenital anomaly or birth defect, or another important event requiring intervention or potentially jeopardizing the participant. It lists top serious-event terms including ascites, bacteraemia, dehydration, general physical health deterioration, disease progression, and metastatic pain. The displayed percentages attached to those terms are terms in the registry record; they do not establish causation or provide a complete event history.
Deaths are not reported in the registry record. The groups are not randomized comparators, and the record does not report event attribution or exposure-adjusted analyses. These counts therefore should be read as descriptive safety observations over the stated assessment period, not as comparative risks or proof that treatment caused any listed event.
12. What the Result Does, and Does Not, Mean
The record establishes that talimogene laherparepvec was studied by direct injection in participants with unresectable pancreatic cancer in a completed phase 1 study. It reports the number of participants with serious and other adverse events in three concentration groups, along with a defined safety observation period. These registry entries describe what was recorded among participants in this study and provide context for the study’s safety monitoring.
The counts do not show that talimogene laherparepvec caused the events. The registry record does not report event attribution, a randomized control group, or a comparative statistical analysis. A single-group study can describe experiences among treated participants, but it cannot by itself separate events associated with treatment from events related to the underlying disease, other care, or other factors. The registry record does not give information that would resolve those possibilities.
The counts also do not establish a relationship between concentration and event occurrence. The concentration groups are not described as randomized or otherwise comparable, and treatment duration differed across groups as reported. No adjustment for these differences is reported. Raw counts cannot establish that one concentration is safer or less safe than another.
Nor do the safety results answer whether treatment changed tumor size, produced an objective response, or altered pain. Those outcomes are listed as secondary measures, but their results are not reported in the registry record. The record lists zero analyses and provides no inferential estimates or confidence intervals for the posted safety counts. Therefore, the results do not support a quantified comparative effect or a claim of efficacy.
The appropriate statistical reading is bounded: the posted figures are descriptive counts within the registry’s stated groups and assessment period. Their interpretation is constrained by small group denominators, absent comparative allocation, unreported missing-data handling, and no reported statistical analysis plan. The figures should not be extended beyond the participants and observation described in the registry record.
13. Why This Trial Matters Statistically
This study is statistically informative as an example of the distinction between documenting events and estimating comparative effects. Its registry record reports participant counts for serious and other adverse events in a phase 1 setting. Such descriptive reporting can make the safety experience visible, while still leaving important questions about precision, attribution, and comparison unanswered.
The single-group model and absence of reported allocation are central to interpretation. The concentration categories may look like groups that invite direct comparison, but the registry record cautions that they are not like-for-like controls. This illustrates why group labels alone do not establish comparability. Random allocation, when used and adequately implemented, is one way to reduce systematic differences between groups; no such allocation is reported for this study.
The treatment duration information also matters. The record reports different median durations across the groups, while the endpoint follows participants until 30 days after the last dose. This highlights a general design issue: event counts can be affected by how long participants receive treatment and remain under observation. Without exposure-adjusted analyses or fuller follow-up details, participant counts cannot answer questions about event frequency over time.
Finally, the record lists tumor-size, response, and pain outcomes but does not report their results or analyses. This is a reminder that an outcome’s appearance in a registry does not mean its findings are available or that the study can answer every listed question. Statistical interpretation depends on the actual results, the analysis plan, outcome completeness, and design—not only on the outcome names.
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 main limitation is the absence of a concurrent control group. The registry record describes a single-group study and states that the dose-level groups are not a like-for-like control comparison. Consequently, the posted data do not support a causal comparison with another treatment or an untreated group, and differences among the concentration groups should not be attributed to concentration.
The group denominators are small, so the event counts provide limited precision. The registry record does not report confidence intervals or other uncertainty estimates. It also does not report an analysis plan, formal tests, or methods for accounting for potential differences among groups. These gaps mean that the strength and uncertainty of any between-group pattern cannot be quantified from the record.
Information about participant characteristics, eligibility details, withdrawals, and missing outcome data is not reported in the registry record. The primary population is identified as ITT, but the record does not explain how missing safety observations were handled or whether outcome ascertainment was complete. The record also does not specify how the category of other adverse events was defined or whether event attribution was assessed.
Median treatment duration differed across the groups, and the record does not explain the reasons. The assessment window is stated, but exposure-adjusted analyses and individual follow-up durations are not reported. Deaths are not reported in the registry record. Finally, secondary tumor and pain outcomes are listed without results. These omissions constrain both safety interpretation and any consideration of antitumor activity.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Talimogene Laherparepvec in Patients With Unresectable Pancreatic Cancer — NCT00402025.
- Registry record last updated 2016-04-15; status last verified 2016-04.
- Results first posted 2016-04-15.
- 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
NCT00402025 is a completed phase 1, single-group study sponsored by BioVex Limited. It evaluated talimogene laherparepvec injected directly into unresectable pancreatic cancer. The record lists enrollment of 17, no masking, and no allocation method. Participants were scheduled to receive 3 doses 3 weeks apart, with possible continuation at the investigator’s discretion until week 15.
The primary endpoint was the number of participants with adverse events from first dose through 30 days after the last dose. The posted results give serious and other adverse-event counts for three concentration groups. The record also lists tumor-size change, overall objective response, and pain-intensity change as secondary outcomes, but their results are not reported in the registry record. The registry record lists zero analyses and does not report a statistical analysis plan or comparative efficacy findings.