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 Carboplatin and Paclitaxel With or Without Viral Therapy in Treating Patients With Recurrent or Metastatic Pancreatic Cancer (NCT01280058), a randomized phase 2 study. The primary outcome is Progression-free Survival Using RECIST v. 1.1.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01280058 |
| Phase | Phase 2 |
| Condition | Pancreatic Acinar Cell Carcinoma, Pancreatic Ductal Adenocarcinoma, Recurrent Pancreatic Carcinoma |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 73 |
| Arms in the primary outcome | 2 |
| Lead sponsor | National Cancer Institute (NCI) |
| Results posted | Yes |
2. Clinical Question
Population
Patients with recurrent or metastatic pancreatic cancer. The registry lists pancreatic acinar cell carcinoma, pancreatic ductal adenocarcinoma, recurrent pancreatic carcinoma, and stage IV pancreatic cancer among the conditions.
Intervention
Wild-type reovirus with carboplatin and paclitaxel. The registry identifies the reovirus as Reovirus Serotype-3 Dearing Strain (Reolysin) in the official trial title.
Comparator
Carboplatin and paclitaxel without reovirus. Patients assigned to this arm could cross over to the reovirus arm after disease progression.
Primary question
How did progression-free survival, measured using RECIST v. 1.1, compare between the two treatment assignments? The registry reports a median for each arm, but does not report a comparative hazard ratio or log-rank test result.
The trial was a randomized phase II study. Its official title describes first-line treatment, while its brief summary frames the population as patients whose pancreatic cancer had returned or spread. The primary endpoint was progression-free survival from study entry to documented progression and/or death, assessed up to 4 years.
The treatment contrast concerns adding wild-type reovirus to carboplatin and paclitaxel. It is not a comparison of reovirus alone against chemotherapy, because both arms received the chemotherapy combination. The crossover option also matters: after progression, patients in the carboplatin-and-paclitaxel arm could receive the reovirus-containing regimen. That option is part of the trial description, but the registry record does not report how many patients crossed over or how crossover was handled in the primary analysis.
The posted medians are 4.9 months in the reovirus-containing arm and 5.2 months in the chemotherapy-only arm. These are separate arm estimates, not a direct estimate of the treatment contrast. The registry record does not report a hazard ratio, log-rank result, or other comparative test result, so the arm medians alone do not establish whether the PFS distributions differed statistically.
3. Trial Design
This was a randomized, parallel, phase II trial with no masking reported. The registry lists enrollment of 73. The posted arm results include 36.0 participants in Arm A, which received wild-type reovirus with carboplatin and paclitaxel, and 37.0 in Arm B, which received carboplatin and paclitaxel. The record describes the trial as completed.
In Arm A, paclitaxel was administered intravenously over 3 hours and carboplatin intravenously over 30 minutes on day 1. Wild-type reovirus was administered intravenously over 60 minutes on days 1-5. Courses were scheduled to repeat every 21 days in the absence of disease progression or unacceptable toxicity. Arm B received paclitaxel and carboplatin as in Arm A, with courses also repeating every 21 days unless progression or unacceptable toxicity occurred. Patients in Arm B could cross over to Arm A after disease progression.
The primary endpoint was progression-free survival using RECIST v. 1.1. Its timeframe ran from study entry to documented progression and/or death, assessed up to 4 years. The registry describes a planned comparison using log-rank tests, Kaplan-Meier curves, and additional Cox proportional hazards analyses. These are described methods; the record does not provide the comparative results of those analyses.
The study start is listed as 2010-12, and primary completion as 2016-01-19. The sponsor is the National Cancer Institute (NCI). The registry record does not report the randomization sequence method, allocation concealment, stratification factors, detailed eligibility criteria, or a rationale for the enrollment target. It also does not report whether the primary analysis followed an intention-to-treat population or another defined analysis population.
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 | Arm A (Wild-type Reovirus, Carboplatin, Paclitaxel) | Arm B (Carboplatin, Paclitaxel) |
|---|---|---|
| STARTED | 36 | 37 |
| COMPLETED | 36 | 37 |
| NOT COMPLETED | 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 | Arm A (Wild-type Reovirus, Carboplatin, Paclitaxel) | Arm B (Carboplatin, Paclitaxel) | Total |
|---|---|---|---|---|
| Participants analysed | 36 | 37 | 73 | |
| Age, Continuous | years | 61.5 (39 to 84) | 66 (45 to 81) | 64 (39 to 84) |
| Sex: Female, Male: Female | Participants | 14 | 18 | 32 |
| Sex: Female, Male: Male | Participants | 22 | 19 | 41 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 1 | 0 | 1 |
| 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 | 2 | 0 | 2 |
| Race (NIH/OMB): White | Participants | 32 | 35 | 67 |
| Race (NIH/OMB): More than one race | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 | 1 | 2 |
| Region of Enrollment: United States | Participants | 36 | 37 | 73 |
6. Primary Endpoint
The registry lists the primary outcome as Progression-free Survival Using RECIST v. 1.1, measured over From study entry to the date of documented progression and/or death, assessed up to 4 years.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | 95% Confidence Interval |
| Unit | months |
| Endpoint classification | Time-to-Event Analysis |
Progression-free survival (PFS) measures the time from study entry until documented disease progression or death, as specified for this trial. Progression was evaluated using RECIST v. 1.1. The endpoint therefore combines disease progression and death into a time-to-event outcome, rather than reporting only tumor response at a particular visit.
PFS is used in trials because it captures how long participants remain alive without documented progression during follow-up. It makes use of the timing of events, not only whether an event occurred by a single fixed assessment date. Kaplan-Meier methods can represent the distribution of event times while accounting for participants whose follow-up ends before an event is recorded. A log-rank test can compare the observed event-time patterns between groups, while a Cox model can estimate a relative hazard under its modeling assumptions.
The registry reports median PFS of 4.9 months for Arm A and 5.2 months for Arm B. The corresponding 95% confidence intervals are 3.0 to 6.3 months and 2.3 to 6.2 months. A median is the estimated time by which half of the relevant event-time distribution has experienced progression or death, under the time-to-event analysis. It does not describe every participant's experience or show the full shape of the distribution.
The confidence intervals convey uncertainty around each arm's median estimate. They are not confidence intervals for the difference between arms. The registry record does not report a comparative hazard ratio, a confidence interval for a treatment contrast, or the log-rank test result. The exact censoring rules, assessment schedule, and handling of missing progression assessments are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary endpoint results are arm-specific median PFS estimates. Arm A, which combined wild-type reovirus with carboplatin and paclitaxel, has a reported median of 4.9 months, with a 95% confidence interval from 3.0 to 6.3 months. Arm B, which received carboplatin and paclitaxel, has a reported median of 5.2 months, with a 95% confidence interval from 2.3 to 6.2 months. These values describe the estimated event-time distributions in each arm.
The confidence intervals indicate that each median is estimated with uncertainty. They should not be read as ranges containing every participant's PFS time. Nor are they intervals for a between-arm effect. Their overlap does not serve as a substitute for the planned log-rank comparison or a hazard ratio analysis. The registry record does not report those comparative statistics, so it is not possible from the posted results to quantify a relative treatment effect or evaluate its precision directly.
The numbers of participants listed with the arm results are 36.0 and 37.0. Those values give context for the reported estimates, but they do not by themselves reveal how many progression or death events occurred, how long follow-up lasted for each participant, or how censoring was distributed. Those details are not reported in the registry record. Enrollment is listed as 73, but it should not be treated as a substitute for the analysis population or the number contributing information at each time point.
The trial description states that the planned analysis would use Kaplan-Meier curves and log-rank tests, with additional Cox proportional hazards analyses. The registry record does not report the log-rank statistic or p-value, Cox hazard ratio, confidence interval for a hazard ratio, or the model results. It therefore supports a descriptive reading of the posted medians, but not a conclusion about the statistical evidence for a difference between treatment assignments.
The opportunity for crossover after progression further distinguishes assignment from later treatment received. The registry record does not report crossover counts or the method used to address crossover in the analysis. Without those details and the comparative analysis results, the medians should be understood as reported arm-level summaries, not as a fully adjusted causal estimate of adding reovirus.
Other listed outcomes include severe adverse events, overall response rate, and overall survival. The record identifies these outcomes but does not provide their outcome results in the registry record for this interpretation. A result for PFS alone cannot stand in for those distinct measures. Likewise, the absence of a reported comparative statistic in the registry record should not be interpreted as proof of no difference; it means that the comparative result is not reported there.
9. Statistical Methods Explained
The registry describes a time-to-event primary endpoint and names several statistical methods. The explanation below is general: it clarifies what these methods are designed to do, without treating a planned method as proof that a particular analysis was completed or reported.
What does a median PFS estimate represent?
A time-to-event outcome records both whether an event occurred and when it occurred. For this trial, the event was documented progression and/or death, with time measured from study entry. The median is a summary of the event-time distribution: it marks the point at which half of the estimated distribution has had an event. It is useful for communicating a typical time point, but it compresses the distribution into a single value. Participants may have event times earlier or later than the median, and the median does not show how the curves behave across the full follow-up period.
In a clinical trial, some participants may leave observation or reach the end of follow-up without a recorded event. Such observations are commonly treated as censored at the last relevant follow-up time, under assumptions about the relationship between censoring and future event risk. The registry identifies Kaplan-Meier methods but does not report the censoring details or explain how missing assessments were handled. Those particulars are not reported in the registry record.
How does Kaplan-Meier estimation work?
Kaplan-Meier estimation builds an event-free survival curve from observed event times. At each event time, the estimate uses the number of participants still under observation and event-free immediately before that time, together with the number of events recorded then. Participants censored before a later event contribute information while they are observed, but not after their censoring time. The resulting curve can be used to estimate the median when it reaches the point corresponding to half the estimated event-free distribution.
This approach is useful because it does not require every participant to have the same follow-up duration. Its interpretation still depends on appropriate outcome assessment and censoring assumptions. The registry reports arm medians and confidence intervals, but does not give the risk sets, event counts, censoring distribution, curve coordinates, or method used to calculate the median confidence intervals.
What would a log-rank test assess?
The log-rank test is a general method for comparing time-to-event distributions between groups. It compares observed event counts with the counts expected under a null hypothesis of no group difference, using the available risk sets at event times. The planned description says that the PFS distributions between the arms would be compared using log-rank tests. The registry record does not report the resulting test statistic or p-value, so the planned comparison cannot be reconstructed from the medians and confidence intervals alone.
A log-rank test assesses evidence about the distributions as a whole; it does not itself provide a direct measure of the size of a treatment effect. Its performance and interpretation are most straightforward when the relative event patterns are reasonably consistent over time. If effects vary over time, a single summary test can be less descriptive of that variation. The registry record does not report whether proportional hazards or other time-pattern assumptions were examined.
What does a Cox proportional hazards model add?
The Cox proportional hazards model is a regression approach for time-to-event data. In its basic form, it estimates a hazard ratio comparing the instantaneous event rates between groups, conditional on being event-free and observed up to a given time. The registry says additional analyses would use this model, but the posted result details do not include a hazard ratio, its confidence interval, covariates, or model diagnostics. No adjusted or unadjusted comparative estimate should therefore be inferred from the two medians.
The proportional hazards assumption means that the hazard ratio is treated as constant over time, subject to the model specification. If that assumption is not appropriate, the hazard ratio may not summarize the treatment contrast well. General methods for checking this assumption include examining time-specific patterns or model diagnostics, but whether such checks were conducted is not reported in the registry record. The registry also does not report whether any covariates were included in the model.
How should the confidence intervals be read?
A confidence interval expresses the uncertainty associated with an estimate under the method used to construct it. The reported 95% confidence intervals apply separately to each arm's median PFS. They are not intervals for a difference in medians or for a hazard ratio. Comparing whether separate intervals overlap is not equivalent to carrying out the planned log-rank test, and it does not provide a formal estimate of the between-arm contrast.
The intervals are relatively broad summaries of uncertainty, but their width alone does not reveal why the estimates are imprecise. Event counts, follow-up patterns, censoring, and the underlying distribution all affect time-to-event precision. The registry record does not report enough detail to assess those components separately.
The analysis description should be distinguished from the results. A plan naming Kaplan-Meier estimation, log-rank testing, and Cox modeling explains the intended analytical framework; it does not supply the outputs. The registry entries contain arm-level medians and confidence intervals but no comparative test or hazard ratio. The registry record also does not report whether there were interim analyses, what missing-data procedures were specified, or whether the analysis followed the original statistical plan.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary PFS outcome and three secondary outcomes: severe (Grade 3+) adverse events classified as possibly, probably, or definitely related to study treatment; overall response rate using RECIST v. 1.1; and overall survival. It also lists six outcome measures in total. The registry record does not report how testing across outcomes was handled, whether any multiplicity adjustment was planned, or which outcome comparisons were considered confirmatory. Without that information, a collection of outcome findings would need cautious interpretation because repeated testing can increase the chance of at least one apparently notable result.
The registry describes planned log-rank testing and additional Cox modeling for PFS, but it does not report a detailed statistical analysis plan, a hierarchy of endpoints, or decision rules for interpreting multiple analyses. It also does not report interim analyses or stopping boundaries. These items are not reported in the registry record; their absence cannot be filled in by assuming a conventional approach.
Missing-data and analysis-population details are also limited. The registry record does not state the primary analysis population, whether all randomized participants were included according to assigned arm, how participants with incomplete follow-up were handled, or what rules applied to missing or unevaluable progression assessments. It does not report the number or pattern of withdrawals or loss to follow-up.
Because Arm B participants could cross over after progression, the handling of crossover in the PFS analysis may be relevant to later outcomes and treatment exposure. The record does not report how many crossed over, whether crossover affected any endpoint analysis, or whether analyses based on treatment received were performed. The medians should therefore be read as posted arm-level results without assumptions about unreported population, missing-data, or multiplicity 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 |
|---|---|---|---|
| Arm A (Wild-type Reovirus, Carboplatin, Paclitaxel) | 36 | 36 | 100.0% |
| Arm B (Carboplatin, Paclitaxel) | 37 | 37 | 100.0% |
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 |
|---|---|
| Arm A (Wild-type Reovirus, Carboplatin, Paclitaxel) | 36 of 36 |
| Arm B (Carboplatin, Paclitaxel) | 37 of 37 |
Most frequent serious adverse event terms
| Event term | Organ system | Arm A (Wild-type Reovirus, Carboplatin, Paclitaxel) | Arm B (Carboplatin, Paclitaxel) |
|---|---|---|---|
| Neutrophil count decreased | Investigations | 15 of 36 | 13 of 37 |
| Anemia | Blood and lymphatic system disorders | 10 of 36 | 11 of 37 |
| White blood cell decreased | Investigations | 10 of 36 | 8 of 37 |
| Nausea | Gastrointestinal disorders | 7 of 36 | 7 of 37 |
| Platelet count decreased | Investigations | 10 of 36 | 4 of 37 |
| Abdominal pain | Gastrointestinal disorders | 6 of 36 | 5 of 37 |
| Blood bilirubin increased | Investigations | 7 of 36 | 4 of 37 |
| Febrile Neutropenia | Blood and lymphatic system disorders | 4 of 36 | 5 of 37 |
| Vomiting | Gastrointestinal disorders | 5 of 36 | 4 of 37 |
| Fatigue | General disorders | 6 of 36 | 2 of 37 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Arm A (Wild-type Reovirus, Carboplatin, Paclitaxel) | Arm B (Carboplatin, Paclitaxel) |
|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | 20 of 36 | 22 of 37 |
| Leukopenia | Blood and lymphatic system disorders | 12 of 36 | 17 of 37 |
| Anemia | Blood and lymphatic system disorders | 9 of 36 | 11 of 37 |
| Thrombocytopenia | Blood and lymphatic system disorders | 10 of 36 | 9 of 37 |
| Febrile Neutropenia | Infections and infestations | 3 of 36 | 4 of 37 |
| Fatigue | General disorders | 4 of 36 | 3 of 37 |
| Infection | Infections and infestations | 4 of 36 | 2 of 37 |
Serious events with the highest arm-level rate: neutrophil count decreased (41.7%), anemia (29.7%), platelet count decreased (27.8%), white blood cell decreased (27.8%), nausea (19.4%).
The registry identifies severe (Grade 3+) adverse events classified as possibly, probably, or definitely related to study treatment as a secondary outcome. It also lists serious adverse event terms, including neutrophil count decreased (41.7%), anemia (29.7%), platelet count decreased (27.8%), white blood cell decreased (27.8%), nausea (19.4%), and blood bilirubin increased (19.4%). These percentages are the reported figures for the listed terms; the record does not identify an arm for each percentage in the registry record.
The percentage for a term should not be treated as the percentage with any serious adverse event, nor should a serious-event label be assumed to mean the same thing as a Grade 3+ severity grade. Seriousness and severity are distinct ways of classifying adverse events. The registry does not provide event-specific counts alongside these percentages, the term-specific arm breakdown, or enough detail to infer a comparison between arms.
The adverse-event group fields list 36 at risk and affected for Arm A and 37 at risk and affected for Arm B. These group-level fields do not identify the number affected by each named term, and should not be read as term-specific incidence figures. The registry record does not report further details about event timing, recurrence, attribution adjudication, or statistical comparisons of safety between arms. These figures describe the reported safety information, not a complete comparative safety analysis.
12. What the Result Does, and Does Not, Mean
The result describes progression-free survival in a randomized comparison of carboplatin and paclitaxel with or without wild-type reovirus. The posted median PFS is 4.9 months in Arm A and 5.2 months in Arm B. Their reported 95% confidence intervals are 3.0 to 6.3 months and 2.3 to 6.2 months, respectively. These are estimates of each arm's time-to-event distribution, with uncertainty around each median.
The result does not provide a direct estimate of the difference between arms. No comparative hazard ratio, confidence interval for a treatment contrast, or log-rank test result is reported in the registry record. The arm medians cannot replace these statistics, and the separate confidence intervals do not establish a formal comparison. The record therefore does not support a claim about the statistical evidence for a difference in PFS.
The trial was randomized, which is a design feature intended to support a fair comparison of assigned treatment groups. However, the registry does not report all details needed to evaluate the analysis, including the analysis population, event counts, censoring, and crossover handling. Patients in the carboplatin-and-paclitaxel arm could cross over after progression; the registry record does not state how many did so. These unknowns limit interpretation of assignment versus treatment actually received.
The listed secondary outcomes address other questions, including response, overall survival, and treatment-related severe adverse events. The PFS result does not answer those questions. Nor do the listed serious adverse-event terms provide a complete, arm-specific comparative safety analysis. Those distinctions matter because one endpoint cannot be used as a proxy for all aspects of clinical outcome.
Overall, the posted result is a descriptive account of median PFS in each arm. It should not be extended into a claim that adding reovirus did or did not change outcomes. The comparative analysis results and several details needed to assess their precision are not reported in the registry record.
13. Why This Trial Matters Statistically
This trial illustrates the difference between reporting outcomes by arm and reporting a comparative treatment effect. The median PFS values of 4.9 months and 5.2 months give readers a concise description of each arm, while their confidence intervals express uncertainty in those separate estimates. Neither element alone quantifies the relative effect of adding reovirus to carboplatin and paclitaxel.
The registry's planned methods also show why time-to-event outcomes need more than a single summary value. Kaplan-Meier estimation uses event timing and can accommodate censoring under its assumptions; a log-rank test compares event-time patterns; and a Cox model can express a relative hazard under proportional-hazards assumptions. The registry names these methods, but the comparative test and model results are not reported. This makes the distinction between a statistical plan and posted analysis results central to interpreting the trial.
The crossover option adds another practical issue for interpreting assigned treatment. The control arm could receive reovirus after progression, but the record does not state whether crossover occurred or how it was handled analytically. That information could matter for interpreting later treatment exposure, particularly for outcomes observed after progression. It should not be guessed from the design description.
Finally, the record demonstrates why safety terms and endpoint definitions need careful reading. A listed serious adverse-event term is not interchangeable with a Grade 3+ severity outcome, and percentages without arm attribution or event-specific counts do not establish a comparative risk. Statistical interpretation depends not only on estimates, but on knowing what each measure represents and which analytical details are available.
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 primary limitation for interpreting the posted PFS result is the absence of a reported comparative statistic. Although the registry describes log-rank and Cox methods, it does not report a log-rank test result, hazard ratio, or confidence interval for the treatment contrast. The two arm-specific medians cannot answer the comparative question on their own.
The registry also does not report event counts, numbers at risk over follow-up, censoring patterns, follow-up duration, or the calculation method for the median confidence intervals. These details would help readers evaluate the precision and assumptions of the time-to-event estimates. The stated endpoint timeframe is assessed up to 4 years, but the record does not give the observed follow-up distribution.
Participants in Arm B could cross over to Arm A after disease progression. Crossover counts and analysis handling are not reported in the registry record. The record also does not give the primary analysis population, missing-assessment rules, or details on withdrawals and loss to follow-up. It is not possible to determine from these registry entries whether a particular population or missing-data method was used.
The safety information is limited for between-arm interpretation. The listed terms have percentages, but arm-specific term results and event counts are not reported in the registry record. The record does not provide results for the named secondary outcomes of response rate and overall survival, or a detailed multiplicity approach. Randomization and the phase II designation describe the design, but do not resolve these reporting gaps or establish how the unreported analyses turned out.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Carboplatin and Paclitaxel With or Without Viral Therapy in Treating Patients With Recurrent or Metastatic Pancreatic Cancer — NCT01280058.
- Registry record last updated 2018-03-09; status last verified 2018-02.
- Results first posted 2018-02-07.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry describes a completed randomized, parallel, unmasked phase II study sponsored by the National Cancer Institute (NCI). It lists enrollment of 73 and compares carboplatin and paclitaxel plus wild-type reovirus against carboplatin and paclitaxel alone in patients with recurrent or metastatic pancreatic cancer. The study start is listed as 2010-12, with primary completion on 2016-01-19.
The primary outcome is progression-free survival using RECIST v. 1.1, measured from study entry to documented progression and/or death and assessed up to 4 years. The registry reports median PFS of 4.9 months for Arm A and 5.2 months for Arm B, with 95% confidence intervals of 3.0 to 6.3 months and 2.3 to 6.2 months. It describes Kaplan-Meier, log-rank, and Cox methods, but does not report comparative test or hazard-ratio results.
Other listed outcomes include severe treatment-related adverse events, overall response rate, and overall survival. The record also lists serious adverse-event terms and percentages. Comparative details for these safety terms, the primary analysis population, crossover handling, and missing-data procedures are not reported in the registry record.