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 Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With Stage II-IV HIV-Associated Hodgkin Lymphoma (NCT01771107), a na phase 1, phase 2 study. The primary outcome is 2-year Progression-free Survival (PFS) (Phase II).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01771107 |
| Phase | Phase 1, Phase 2 |
| Condition | AIDS-Related Hodgkin Lymphoma, Ann Arbor Stage II Hodgkin Lymphoma, Ann Arbor Stage IIA Hodgkin Lymphoma |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 41 |
| Arms in the primary outcome | n/a |
| Lead sponsor | National Cancer Institute (NCI) |
| Results posted | Yes |
2. Clinical Question
Population
Patients with stage II-IV HIV-associated Hodgkin lymphoma, including the listed Ann Arbor stage categories and classic Hodgkin lymphoma. The registry record gives an enrollment of 41, but does not report a more detailed description of the primary-endpoint population.
Intervention
Brentuximab vedotin given with doxorubicin hydrochloride, vinblastine sulfate, and dacarbazine. The treatment description specifies intravenous dosing on days 1 and 15 of repeating 28-day cycles, for up to 6 cycles, unless disease progression or unacceptable toxicity occurs.
Comparator
There is no concurrent comparator group identified. The record describes a single-group study with allocation listed as not applicable and no masking. The phase I and phase II groups are not a randomized, like-for-like control comparison.
Primary question
The phase II primary endpoint is two-year progression-free survival, estimated using Kaplan-Meier methods with a 95% confidence interval. The registry record does not report the estimate or interval, so the posted information does not show the endpoint result or its precision.
3. Trial Design
This is a pilot phase I/II study of brentuximab vedotin with combination chemotherapy in patients with stage II-IV HIV-associated Hodgkin lymphoma. The registry identifies the study as single group, with allocation listed as not applicable and masking listed as none. It is therefore not a randomized comparison of the regimen against a control treatment. The phase I and phase II groups listed in the safety record should not be read as randomized treatment arms.
The treatment description specifies doxorubicin hydrochloride, vinblastine sulfate, and dacarbazine intravenously on days 1 and 15. Brentuximab vedotin is also given intravenously over 30 minutes on those days. Cycles repeat every 28 days for up to 6 cycles, unless disease progression or unacceptable toxicity occurs. The record lists brentuximab vedotin at 1.2 mg/kg for both the phase I and phase II safety groups. Further details of dose selection or any dose-escalation procedure are not reported in the registry record.
The study enrolled 41 participants. Its status is completed; the recorded start date is 2013-03-08 and primary completion date is 2021-10-15. The National Cancer Institute is listed as sponsor. These administrative details describe the trial record, not the size or precision of the primary endpoint analysis.
The main phase II endpoint is two-year progression-free survival. The registry describes a Kaplan-Meier estimate and a 95% confidence interval calculated using standard errors based on Greenwood's formula. Although the endpoint and method are specified, its numerical estimate and interval are not reported in the registry record. The record lists 21 outcome measures and 0 analyses; that entry does not establish whether analyses were conducted outside the registry reporting.
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 | Phase I - Brentuximab 1.2 mg/kg | Phase II - Brentuximab 1.2 m/kg |
|---|---|---|
| STARTED | 6 | 35 |
| COMPLETED | 5 | 27 |
| NOT COMPLETED | 1 | 8 |
Reasons for not completing this period:
| Reason | Phase I - Brentuximab 1.2 mg/kg | Phase II - Brentuximab 1.2 m/kg |
|---|---|---|
| Adverse Event | 1 | 3 |
| Withdrawal by Subject | 0 | 2 |
| Lost to Follow-up | 0 | 1 |
| participant moved | 0 | 1 |
| Other | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: Participants entered into the phase I portion of the study
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: Participant enrolled on the study
| Characteristic | Unit | Phase I - Brentuximab 1.2 mg/kg | Phase II - Brentuximab 1.2 mg/kg | Total |
|---|---|---|---|---|
| Participants analysed | 6 | 35 | 41 | |
| Age, Continuous | years | 38.5 (SD 12.2) | 44.3 (SD 12.0) | 43.4 (SD 12.0) |
| Sex: Female, Male: Female | Participants | 1 | 2 | 3 |
| Sex: Female, Male: Male | Participants | 5 | 33 | 38 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 9 | 9 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 5 | 16 | 21 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 1 | 10 | 11 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 1 | 10 | 11 |
| Race (NIH/OMB): White | Participants | 4 | 14 | 18 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 | 11 | 12 |
| Region of Enrollment: United States | participants | 6 | 26 | 32 |
| Region of Enrollment: France | participants | 0 | 9 | 9 |
6. Primary Endpoint
The registry lists the primary outcome as 2-year Progression-free Survival (PFS) (Phase II), measured over 2 years.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | proportion of participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is two-year progression-free survival in phase II, expressed as a proportion of participants. Progression-free survival is generally used to describe how long participants remain alive without disease progression; the specific event definition and assessment rules for this trial are not reported in the registry record. The stated endpoint summarizes status at two years rather than giving a complete account of each participant's course.
The registry specifies Kaplan-Meier estimation. In general, this method estimates time-to-event outcomes while accounting for participants whose follow-up ends before an event is observed. A two-year estimate can therefore incorporate information from follow-up durations that differ, subject to the method's assumptions and the study's censoring procedures. The registry record does not give the number at risk at two years or explain its censoring rules.
The endpoint is accompanied by a 95% confidence interval, with standard errors calculated using Greenwood's formula. In general, a confidence interval conveys the statistical uncertainty around an estimated value; a wider interval indicates less precision. The numerical estimate and interval are not reported in the registry record, so the endpoint's value and precision cannot be described from the posted information. No conclusion about the observed two-year progression-free survival can be drawn from the endpoint description alone.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies two-year progression-free survival as the primary phase II endpoint and specifies how it was to be estimated. It does not report the estimate or its 95% confidence interval. Consequently, the posted information establishes the endpoint and planned statistical form, but does not show the endpoint result, the degree of precision, or whether the estimate is compatible with a broad range of values.
The trial is single group, with no randomized comparator. Its registry record lists a phase I group and a phase II group for safety reporting, both at brentuximab vedotin 1.2 mg/kg. These groups do not provide a like-for-like control comparison. Differences between observations in separate trial phases cannot, on the record described, be interpreted as randomized evidence of a treatment effect.
The posted safety information gives counts of participants at risk and affected for serious and other adverse events, as well as deaths, for each listed group. It also lists several serious adverse-event terms as percentages. These are descriptive safety summaries, not substitutes for the missing primary endpoint estimate. The record does not provide enough detail to infer the timing, duration, severity distribution, or attribution of every event from these figures alone.
The record describes a pilot phase I/II study and lists an enrollment of 41. A pilot study can provide descriptive information, but the registry information does not supply a sample-size justification, a precision target, or the primary endpoint result. Such items are not reported in the registry record. The enrollment figure alone does not establish how precisely the primary endpoint was estimated.
Sample-size planning illustrations use assumptions stated for those illustrations: two-sided significance level 0.05, equal allocation between two arms, and a normal approximation, with the target effect set as a stated fraction of the observed effect. For time-to-event outcomes, those illustrations refer to total events; for other outcomes, they refer to participants per arm. These are planning illustrations, not the trial's own design or observed power. In particular, the hypothetical equal-allocation comparison does not change the fact that this trial is recorded as single group and has no randomized control comparison.
9. Statistical Methods Explained
What does the Kaplan-Meier estimate describe?
In general, Kaplan-Meier estimation is a time-to-event method. It uses the observed timing of events and incorporates follow-up that ends before an event has been recorded. This makes it useful when participants have different lengths of observation. For the trial's primary endpoint, the registry specifies a two-year progression-free survival estimate. It does not report the estimate, the event definition in detail, or the number at risk at the two-year point.
A time-to-event estimate is not the same as a simple proportion calculated by dividing the number of participants without an event by the enrollment. Kaplan-Meier estimation uses event times and follow-up information. The registry's description identifies this method but does not provide the event-time data needed to independently reproduce the estimate. The endpoint's population is also not specified in the registry description.
What does the confidence interval add?
The registry specifies a 95% confidence interval around the Kaplan-Meier estimate, using standard errors based on Greenwood's formula. In general, a confidence interval expresses uncertainty due to sampling variation under the model and analysis assumptions. It gives a range of values consistent with the data and method at the stated confidence level; it is not a guarantee that the true value lies within the interval. The interval's width is important because an estimate without its uncertainty can give an incomplete impression of precision.
Neither the estimate nor its interval is reported in the registry record. This prevents interpretation of the numerical endpoint result and prevents assessment of its precision. The method description alone does not reveal whether the estimate is high or low, or whether the interval is narrow or wide.
Why use Greenwood's formula?
In general, Greenwood's formula estimates the variance of a Kaplan-Meier survival estimate. That variance is used to derive a standard error and, in turn, a confidence interval. The calculation reflects the number and pattern of observed events and the participants remaining under observation over time. Precision typically decreases when fewer participants remain under observation, but the registry record does not give the risk set over follow-up for this endpoint.
Confidence intervals for time-to-event estimates can depend on the construction method and assumptions. The registry record names the standard-error approach but does not report additional interval-construction details or sensitivity analyses. No alternative estimate or analysis is reported in the registry record.
What can the safety summaries establish?
The registry presents affected-participant counts for serious and other adverse events, along with the corresponding at-risk counts, by phase group. Such summaries describe how many participants were recorded as affected in the registry's reporting framework. They do not, on their own, describe event duration, recurrence, timing, or the number of events per participant. The listed serious-event terms and percentages are also descriptive; their interpretation depends on definitions and denominators that are not fully detailed in the record excerpt.
General statistical caution is warranted when interpreting event percentages from groups of different sizes: the same percentage can reflect different underlying counts, and a percentage can be unstable when the group is small. The record's phase I and phase II entries should not be treated as a controlled treatment contrast, since the study is single group and not randomized. The posted summaries do not establish a comparative causal effect.
What are the planning illustrations?
The stated planning assumptions describe hypothetical calculations, not the trial's original design. They use a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and a target effect expressed as a fraction of the observed effect. For time-to-event outcomes, the planning quantity is total events; for other outcomes, it is participants per arm. These assumptions do not describe the trial's single-group enrollment as a randomized two-arm study, and the illustrations must not be read as observed power. The registry record does not report the trial's own sample-size justification.
10. Exact Estimates for Each Arm
No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.
| Arm | Participants | Events | Observed % | Clopper-Pearson 95% CI | Wilson 95% CI | Bayesian 95% credible interval |
|---|---|---|---|---|---|---|
| Phase I - Brentuximab 1.2 mg/kg | 6 | 0 | 0.0% | 0.0% to 45.9% | 0.0% to 39.0% | 0.4% to 41.0% |
| Phase II - Brentuximab 1.2 mg/kg | 35 | 0 | 0.0% | 0.0% to 10.0% | 0.0% to 9.9% | 0.1% to 9.7% |
R code and output
arm <- c("Phase I - Brentuximab 1.2 mg/kg", "Phase II - Brentuximab 1.2 mg/kg")
n <- c(6, 35)
events <- c(0, 0)
for (i in seq_along(n)) {
ci <- binom.test(events[i], n[i])$conf.int # Clopper-Pearson exact interval
cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i]) # Bayesian, uniform Beta(1,1) prior
wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}
ARM Phase I - Brentuximab 1.2 mg/kg 6 0 0.0 0.0 45.9 0.0 39.0 0.4 41.0
ARM Phase II - Brentuximab 1.2 mg/kg 35 0 0.0 0.0 10.0 0.0 9.9 0.1 9.711. Multiplicity, Missing Data and Analysis Populations
The registry lists 21 outcome measures and 0 analyses. The outcomes include adverse-event frequency, partial and complete response rates, two-year overall survival, overall survival, and event-free survival. This range of outcomes raises a general multiplicity issue: when many outcomes are assessed, the chance of at least one apparently unusual result can increase if each is interpreted without accounting for the others. The registry record does not report a multiplicity adjustment, a hierarchy of confirmatory outcomes, or a statistical analysis plan describing how multiple outcomes were handled.
The primary endpoint is identified as two-year progression-free survival, but its estimate and confidence interval are not reported in the registry record. The record does not explain how missing endpoint observations or incomplete follow-up were handled, nor does it report a missing-data sensitivity analysis. For time-to-event analyses, censoring is generally part of the method, but the trial-specific censoring rules are not reported in the registry record.
The primary-endpoint population field is blank. The record does not identify an intention-to-treat, per-protocol, or other analysis population for this endpoint. The enrollment of 41 is reported, but the registry does not state how many participants contributed to the primary analysis or how exclusions, if any, were handled. The 0 analyses entry is a registry reporting detail; it should not be taken as evidence that no analysis occurred. Further information about the analysis populations, missing data, and multiplicity is not reported in the registry record.
12. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Phase I - Brentuximab 1.2 mg/kg | 3 | 6 | 50.0% |
| Phase II - Brentuximab 1.2 mg/kg | 16 | 35 | 45.7% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Phase I - Brentuximab 1.2 mg/kg | 0 of 6 |
| Phase II - Brentuximab 1.2 mg/kg | 3 of 35 |
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 |
|---|---|
| Phase I - Brentuximab 1.2 mg/kg | 6 of 6 |
| Phase II - Brentuximab 1.2 mg/kg | 34 of 35 |
Most frequent serious adverse event terms
| Event term | Organ system | Phase I - Brentuximab 1.2 mg/kg | Phase II - Brentuximab 1.2 mg/kg |
|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | 0 of 6 | 4 of 35 |
| Neutrophil count decreased | Investigations | 0 of 6 | 4 of 35 |
| Peripheral sensory neuropathy | Nervous system disorders | 1 of 6 | 3 of 35 |
| Abdominal pain | Gastrointestinal disorders | 0 of 6 | 2 of 35 |
| Diarrhea | Gastrointestinal disorders | 0 of 6 | 2 of 35 |
| Sepsis | Infections and infestations | 0 of 6 | 2 of 35 |
| White blood cell decreased | Investigations | 0 of 6 | 2 of 35 |
| Peripheral motor neuropathy | Nervous system disorders | 2 of 6 | 0 of 35 |
| Anemia | Blood and lymphatic system disorders | 0 of 6 | 1 of 35 |
| Coronary artery disease | Cardiac disorders | 0 of 6 | 1 of 35 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Phase I - Brentuximab 1.2 mg/kg | Phase II - Brentuximab 1.2 mg/kg |
|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | 2 of 6 | 17 of 35 |
| Neutrophil count decreased | Investigations | 2 of 6 | 17 of 35 |
| Peripheral sensory neuropathy | Nervous system disorders | 3 of 6 | 16 of 35 |
| Constipation | Gastrointestinal disorders | 1 of 6 | 13 of 35 |
| White blood cell decreased | Investigations | 1 of 6 | 13 of 35 |
| Nausea | Gastrointestinal disorders | 2 of 6 | 11 of 35 |
| Fatigue | General disorders | 2 of 6 | 11 of 35 |
| Diarrhea | Gastrointestinal disorders | 3 of 6 | 8 of 35 |
| Alkaline phosphatase increased | Investigations | 3 of 6 | 7 of 35 |
| Lymphocyte count decreased | Investigations | 1 of 6 | 9 of 35 |
Serious events with the highest arm-level rate: peripheral motor neuropathy (33.3%), lung infection (16.7%), peripheral sensory neuropathy (16.7%), febrile neutropenia (11.4%), neutrophil count decreased (11.4%).
The serious adverse-event summaries list a phase I group and a phase II group, both titled as receiving brentuximab vedotin 1.2 mg/kg. For phase I, the serious-event figures are 6 at risk and 3 affected; the other-event figures are 6 at risk and 6 affected, with 0 deaths. For phase II, the serious-event figures are 35 at risk and 16 affected; the other-event figures are 35 at risk and 34 affected, with 3 deaths. These are descriptive counts within the registry's groupings, not a randomized comparison.
The registry also lists serious adverse-event terms with percentages: peripheral motor neuropathy, 33.3%; lung infection, 16.7%; peripheral sensory neuropathy, 16.7%; febrile neutropenia, 11.4%; neutrophil count decreased, 11.4%; and abdominal pain, 5.7%. The record does not provide further denominator or timing details for these listed percentages in the information available.
These summaries should not be interpreted as rates of events per unit of time, as event totals, or as evidence that the intervention caused a particular event. The figures do not describe event duration or recurrence. The registry record does not report additional details needed for those interpretations.
13. What the Result Does, and Does Not, Mean
The registry record describes a pilot phase I/II trial of brentuximab vedotin with combination chemotherapy in stage II-IV HIV-associated Hodgkin lymphoma. It specifies two-year progression-free survival as the primary phase II endpoint and names Kaplan-Meier estimation with a 95% confidence interval based on Greenwood's formula. These details explain what outcome was selected and the stated approach to estimation.
The primary endpoint estimate and confidence interval are not reported in the registry record. Therefore, the posted information does not establish the observed two-year progression-free survival or how precisely it was estimated. The study's completed status and enrollment of 41 do not fill that reporting gap.
The safety information gives counts for serious and other adverse events in the listed phase groups, along with deaths and selected serious-event percentages. These figures are descriptive. The study is single group, not randomized, so the phase groups do not serve as a like-for-like control comparison. The posted information cannot establish a causal contrast between the regimen and another treatment.
More generally, an outcome estimate is not by itself proof of a treatment effect. Interpretation depends on study design, measurement rules, follow-up, analysis choices, and uncertainty. The registry record does not report important details such as the primary analysis population, missing-data handling, and multiplicity approach. No medical recommendation follows from the registry summary. It documents the trial's stated question and selected results information, while leaving the primary endpoint result unavailable in the registry record.
14. Why This Trial Matters Statistically
This trial raises several statistical issues relevant to interpreting early-phase studies. Its phase I/II structure combines a pilot treatment context with a phase II primary endpoint, but the record identifies the overall model as single group. Without a randomized control group, the study's observations can describe outcomes and safety within the trial, but cannot by themselves provide a randomized comparison against another treatment.
The specified primary endpoint is a time-to-event measure summarized at two years. Kaplan-Meier estimation and a confidence interval are appropriate statistical features to report for such an endpoint, because they convey both an estimate and its uncertainty while accounting for differing follow-up. In this case, the registry describes the method but does not report the estimate or interval. This illustrates why a statistical method description cannot replace the numerical result needed for interpretation.
The safety record also illustrates the distinction between counts, percentages, and comparative evidence. Adverse-event summaries can describe what was recorded in a study group, but they do not automatically establish causation or permit a fair treatment comparison. The record's phase-group labels should not be mistaken for randomization.
Finally, the registry lists multiple outcome measures but does not describe multiplicity procedures, missing-data methods, or the analysis population for the primary endpoint. Those details affect how results should be interpreted. The record thus offers useful design and methods information while leaving key elements of endpoint interpretation not reported in the registry record.
15. 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 consequential limitation for interpreting efficacy is that the registry record does not report the numerical two-year progression-free survival estimate or its 95% confidence interval. The primary endpoint's detailed event definition, analysis population, number at risk over time, and censoring rules are also not reported in the registry record. Without these details, neither the endpoint result nor its precision can be assessed from the posted information.
The study is listed as single group, with allocation not applicable and no masking. It has no randomized control comparison, so the phase I and phase II safety groups cannot be treated as like-for-like comparator arms. The record does not report the rationale for sample size or dose selection, and it does not give additional information about the conduct of any interim analyses or the statistical plan.
Although 21 outcome measures are listed, the registry record does not report how multiplicity was handled or how missing observations were addressed. The primary-endpoint population field is blank, and the record does not identify which participants were included in the analysis. The safety summaries lack further details about event timing, duration, recurrence, and attribution in the information recorded. These limitations constrain interpretation of the posted information; they do not establish that such details were absent from the trial's conduct or from other records.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With Stage II-IV HIV-Associated Hodgkin Lymphoma — NCT01771107.
- Registry record last updated 2025-08-15; status last verified 2025-08.
- Results first posted 2023-03-03.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
19. Record Summary
NCT01771107 is a completed pilot phase I/II, single-group trial sponsored by the National Cancer Institute. It enrolled 41 participants with stage II-IV HIV-associated Hodgkin lymphoma. The recorded start date is 2013-03-08, and the primary completion date is 2021-10-15.
The intervention combined brentuximab vedotin with doxorubicin hydrochloride, vinblastine sulfate, and dacarbazine. The phase II primary endpoint was two-year progression-free survival, estimated using Kaplan-Meier methods with a 95% confidence interval based on Greenwood's formula. The numerical endpoint result and interval are not reported in the registry record.
The registry lists 21 outcome measures and 0 analyses. It reports adverse-event counts by phase group and selected serious-event percentages, but the groups are not a randomized control comparison. Details of the analysis population, missing-data handling, multiplicity, and sample-size justification are not reported in the registry record.