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 Efficacy and Safety of Ofatumumab Retreatment and Maintenance Treatment in Patients With B-cell Chronic Lymphocytic Leukemia (CLL) (NCT00802737), a na phase 4 study. The primary outcome is Number of Participants (Par.) Classified as Responders (Rs) and Non-responders (NRs) for Objective Response in Accordance With the National Cancer Institute Working Group (NCIWG) 1996 Guidelines.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00802737 |
| Phase | Phase 4 |
| Condition | Leukaemia, Lymphocytic, Chronic |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 29 |
| Arms in the primary outcome | n/a |
| Lead sponsor | GlaxoSmithKline |
| Results posted | Yes |
2. Clinical Question
Population
Patients with chronic lymphocytic leukemia who had previously responded or had stable disease after ofatumumab treatment in the ongoing Hx-CD20-406 trial. The registry reports enrollment of 29 participants. The primary endpoint population was the Full Analysis Set: participants exposed to study drug, irrespective of compliance with the planned course. Some participants were not evaluable because of withdrawal, refusal, non-trial drug-related adverse events, or death.
Intervention
Ofatumumab retreatment followed by maintenance. The stated regimen began with eight once-weekly infusions: one infusion of 300 mg and seven infusions of 2000 mg. This was followed by 2000 mg once monthly for two years.
Comparator
There was no randomized comparator. The registry describes a single-group trial with no masking. Its allocation field is recorded as not applicable, so the treatment groups listed in the safety results should not be read as randomized, equivalent comparison arms.
Primary question
The primary endpoint counted participants classified as responders or non-responders for objective response under the National Cancer Institute Working Group 1996 guidelines, from treatment start at Week 0/Visit 2 until Week 52. A responder needed a qualifying complete remission, nodular partial remission, or partial remission at two consecutive visits at least 56 days apart. The posted results do not report the responder and non-responder totals, so the registry record does not establish the observed response count.
3. Trial Design
This was a phase 4, single-group, international, multicenter trial of ofatumumab retreatment and maintenance in chronic lymphocytic leukemia. It was sponsored by GlaxoSmithKline and is listed as completed. The registry records a start date of 2009-01 and a primary completion date of 2011-09. Enrollment was 29 participants.
Participants had previously responded or had stable disease after receiving ofatumumab in Hx-CD20-406. The study therefore addressed retreatment and continued maintenance in a selected population with prior exposure and a prior response or stabilization; it was not a trial of initial treatment in an unselected CLL population. The registry’s brief description states that efficacy and safety were investigated.
The stated regimen consisted of eight once-weekly infusions, comprising one 300 mg infusion and seven 2000 mg infusions, followed by 2000 mg once monthly for two years. The registry lists no masking and describes a single-group model. There was no randomized control group, and allocation is recorded as not applicable. Consequently, the trial does not offer a randomized estimate of how outcomes would differ under another treatment or under no retreatment.
The primary outcome was the number classified as responders and non-responders for objective response using the National Cancer Institute Working Group 1996 guidelines. Its assessment window ran from treatment start at Week 0/Visit 2 until Week 52. The registry also lists secondary outcomes including duration of response, progression-free survival, time to next CLL treatment, overall survival, tumor-size change at specified follow-up visits, and human anti-human antibody results.
The registry record does not report the rationale for the enrollment target, a formal sample-size justification, details of interim analyses, or a full statistical analysis plan. Those omissions limit what can be concluded about the design choices beyond the details explicitly recorded.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: Completed study Hx-CD20-406 (Study OMB111773; NCT00349349)
Overall Study
| Stage | 2000 mg Ofatumumab + DR | 2000 mg Ofatumumab + BFR | 2000 mg Ofatumumab + Other |
|---|---|---|---|
| STARTED | 17 | 11 | 1 |
| COMPLETED | 0 | 0 | 0 |
| NOT COMPLETED | 17 | 11 | 1 |
Reasons for not completing this period:
| Reason | 2000 mg Ofatumumab + DR | 2000 mg Ofatumumab + BFR | 2000 mg Ofatumumab + Other |
|---|---|---|---|
| Withdrawn due to Disease Progression | 9 | 3 | 0 |
| Death | 6 | 5 | 1 |
| Adverse Event | 1 | 0 | 0 |
| Received Prohibited Therapy | 1 | 0 | 0 |
| Ongoing CLL-Treatment | 0 | 1 | 0 |
| Participant too Unwell | 0 | 2 | 0 |
Analysis population for the primary outcome, as defined in the registry: Full Analysis Set (FAS): all participants who had been exposed to study drug irrespective of their compliance to the planned course of treatment. Some participants were not evaluable (NE) due to participant withdraw, refusal, non-trial drug-related adverse events, and death.
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 | 2000 mg Ofatumumab + DR | 2000 mg Ofatumumab + BFR | 2000 mg Ofatumumab + Other | Total |
|---|---|---|---|---|---|
| Participants analysed | 17 | 11 | 1 | 29 | |
| Age, Continuous | Years | 64.8 (SD 5.83) | 66.9 (SD 9.08) | 84.0 (SD NA) | 66.3 (SD 7.85) |
| Sex: Female, Male: Female | Participants | 4 | 4 | 1 | 9 |
| Sex: Female, Male: Male | Participants | 13 | 7 | 0 | 20 |
| Race/Ethnicity, Customized: Asian | participants | 1 | 0 | 0 | 1 |
| Race/Ethnicity, Customized: White | participants | 16 | 11 | 1 | 28 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants (Par.) Classified as Responders (Rs) and Non-responders (NRs) for Objective Response in Accordance With the National Cancer Institute Working Group (NCIWG) 1996 Guidelines, measured over Start of treatment (Week 0/Visit 2) until Week 52.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is a count of participants categorized as responders or non-responders for objective response. It is a categorical outcome: each evaluable participant is placed in a response category according to the registry’s stated criteria, rather than being summarized as a continuous measurement such as tumor size.
Under the National Cancer Institute Working Group 1996 guidelines, complete remission, nodular partial remission, and partial remission could qualify as response, but the qualifying response had to be present on two consecutive visits at least 56 days apart. Stable disease and progressive disease were classified as non-response. The registry’s descriptions distinguish these categories using clinical and laboratory features. For example, the stated partial-remission criterion includes a decrease of at least 50% in lymphocytes or lymphadenopathy, while the progressive-disease criterion includes a new lesion or an increase of at least 50% from baseline.
Using defined response criteria makes the endpoint more explicit and reproducible than an informal judgment of improvement. Requiring confirmation at separate visits also means that a response observed at one assessment alone would not meet the stated definition. These are features of the endpoint definition, not evidence that a particular response occurred.
The primary endpoint’s timeframe is treatment start at Week 0/Visit 2 until Week 52. The registry says the analysis population included all participants exposed to study drug, irrespective of compliance, while also noting that some participants were not evaluable. The actual numbers classified as responders, non-responders, or not evaluable are not reported in the registry record. Therefore, the endpoint definition is available, but the primary response result cannot be assessed from the posted results described in the record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry describes a clinically selected group: participants had previously responded or had stable disease after ofatumumab in Hx-CD20-406. The design then examined ofatumumab retreatment and maintenance in that context. This selection matters when interpreting any result: findings in people with this treatment history would not automatically describe people with CLL who had not received ofatumumab or who had a different prior course.
The key efficacy endpoint is clearly defined, including the response categories, confirmation requirement, and assessment window. However, the registry record does not report the primary endpoint’s responder and non-responder totals. Without those results, neither the observed response count nor the proportion of participants classified in each category can be described. No efficacy conclusion should be inferred from the endpoint definition alone.
The single-group design also constrains interpretation. In general, observing outcomes after treatment in one group does not isolate the treatment’s effect from the natural course of disease, participant selection, prior treatment history, or other influences. A randomized comparison can help address such alternative explanations by balancing factors across groups; this trial’s registry description does not include such a comparator. The listed safety groups are not a substitute for a randomized control group, and the record does not establish them as like-for-like treatment comparisons.
The safety results report affected-participant counts for serious and other adverse events in three labeled groups. For serious events, the record lists 11 of 17 at risk in the group titled 2000 mg Ofatumumab + DR, 10 of 11 in 2000 mg Ofatumumab + BFR, and 1 of 1 in 2000 mg Ofatumumab + Other. For other adverse events, the corresponding counts are 15 of 17, 11 of 11, and 1 of 1. These are descriptive counts within the listed groups, not randomized estimates of comparative safety. The record does not define DR, BFR, or Other, so their meanings should not be assumed.
The listed serious-event terms include urinary tract infection and disease progression, each shown as 100.0%, as well as pneumonia at 18.2%, neutropenia and dyspnea at 17.6% each, and bronchopneumonia at 11.8%. The registry does not provide enough context in the listed terms to establish their denominators or whether participants could contribute to more than one term. These percentages should therefore be read as reported descriptions, not as comparative risks or as evidence of causation.
Overall, the record supplies treatment details, endpoint definitions, and some safety counts, but not the primary efficacy outcome totals. The numerical precision of the safety entries does not compensate for the lack of a control group or for missing context about the event-term percentages. The registry record does not report a treatment-effect estimate or its confidence interval for the primary endpoint.
9. Statistical Methods Explained
What does the primary response count represent?
The primary endpoint classifies participants according to whether they met the stated objective-response criteria. In general, a categorical endpoint turns an individual outcome into a defined category, which can then be summarized as counts. Here, the categories include response and non-response, and the registry also notes that some participants were not evaluable. The registry describes the criteria but does not report the resulting primary counts.
Response required complete remission, nodular partial remission, or partial remission at two consecutive visits at least 56 days apart. This confirmation rule defines how repeated assessments contribute to classification. It is part of the endpoint, not a statistical adjustment. A participant who did not meet one of the specified response categories was classified as a non-responder if classified as having stable disease or progressive disease under the stated definition.
Why does the single-group design matter?
In general, an outcome observed in a treated group describes what happened among the participants studied. It does not, by itself, show what would have happened to those same participants under an alternative strategy. A comparison group can provide a reference, and random assignment can make groups more comparable on average. This record describes a single-group trial with no masking and no randomized comparator, so it cannot directly estimate a randomized treatment contrast.
The listed groups in the safety results have different labels and different numbers at risk. The registry does not explain the abbreviations DR and BFR or define Other. Without that context and without random assignment, differences across those group summaries should not be interpreted as treatment effects. The safety counts are descriptive within the categories recorded.
How should counts and percentages be read?
For a count endpoint, a numerator describes how many participants had a recorded event or classification. Its interpretation depends on the population at risk and on the rules for follow-up and event recording. In general, a percentage expresses a count relative to some denominator, but the denominator must be clear before the percentage can be interpreted. The serious-event-term percentages in this record are not accompanied by enough detail to confirm their denominator or how multiple events per participant were handled.
A confidence interval, in general, expresses statistical uncertainty around an estimate under specified assumptions. A narrow interval indicates greater precision than a wide interval, while neither width nor statistical significance alone establishes clinical importance. The registry record does not report a confidence interval or a primary response estimate, so precision for the primary response endpoint cannot be evaluated from the posted results.
What does the planning illustration mean?
In general, a sample-size calculation asks how many participants might be needed to detect a specified effect under chosen statistical assumptions. The planning illustration associated with this analysis uses a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It defines the effect to detect as a stated fraction of the observed effect. For time-to-event outcomes, its stated convention is a total number of events; for other outcomes, it is participants per arm.
Such a calculation is a planning exercise, not an observed result. It is not observed power, and it does not show that the trial enrolled enough participants to detect an effect. The trial itself is described as single-group, whereas the illustration assumes equal allocation between two arms. Any planning values should therefore be understood as hypothetical comparisons under the stated assumptions, not as the design actually used in this study. The registry record does not report the trial’s own sample-size justification.
How do time-to-event outcomes differ?
Several listed secondary outcomes are time-to-event measures, including duration of response, progression-free survival, time to next CLL treatment, and overall survival. In general, these outcomes concern the time until a defined event, and analysis may account for participants whose event has not been observed by the end of follow-up. That feature differs from a simple count at one assessment. The registry lists these outcomes, but the outcome results and details of their analysis are not reported in the registry record.
Other listed secondary outcomes concern the median percent change in tumor size from baseline at Month 4, Month 12, and Month 24, as well as human anti-human antibody results. These have different measurement structures from the primary response classification. A full statistical interpretation would require their outcome values, analysis populations, handling of missing observations, and analysis methods; those details are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists multiple outcomes beyond the primary response classification, including duration of response, progression-free survival, time to next CLL treatment, overall survival, tumor-size change at Month 4, Month 12, and Month 24, and human anti-human antibody results. The registry record does not report whether the analyses were arranged in a prespecified hierarchy, whether any adjustment for multiple testing was planned, or how formal claims across multiple outcomes were controlled. When many outcomes are examined, the chance of at least one apparently unusual result can increase; in general, a prespecified multiplicity strategy helps explain how such results should be interpreted. No such strategy is reported.
The Full Analysis Set is defined as all participants exposed to study drug, irrespective of compliance with the planned course. This describes who was intended for that analysis population; it does not by itself specify how missing endpoint data were handled. The registry notes that some participants were not evaluable because of withdrawal, refusal, non-trial drug-related adverse events, and death. The number of participants in each reason category and the method used to address non-evaluable outcomes are not reported in the registry record.
Details of imputation, censoring rules, sensitivity analyses, and analysis-specific populations are also not reported in the registry record. These omissions matter because missing outcome information can affect a categorical response count, while incomplete follow-up can affect time-to-event outcomes. It is not possible to determine from the record whether missing data were assumed to be absent, handled through a specified model, or treated in another way.
The registry also does not report interim-analysis procedures or a complete statistical analysis plan. Consequently, the prespecification and implementation of the full analysis strategy cannot be assessed from the registry entry alone.
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 |
|---|---|---|---|
| 2000 mg Ofatumumab + DR | 11 | 17 | 64.7% |
| 2000 mg Ofatumumab + BFR | 10 | 11 | 90.9% |
| 2000 mg Ofatumumab + Other | 1 | 1 | 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 |
|---|---|
| 2000 mg Ofatumumab + DR | 15 of 17 |
| 2000 mg Ofatumumab + BFR | 11 of 11 |
| 2000 mg Ofatumumab + Other | 1 of 1 |
Most frequent serious adverse event terms
| Event term | Organ system | 2000 mg Ofatumumab + DR | 2000 mg Ofatumumab + BFR | 2000 mg Ofatumumab + Other |
|---|---|---|---|---|
| Disease progression | General disorders | 2 of 17 | 1 of 11 | 1 of 1 |
| Bronchopneumonia | Infections and infestations | 2 of 17 | 1 of 11 | 0 of 1 |
| Pneumonia | Infections and infestations | 1 of 17 | 2 of 11 | 0 of 1 |
| Neutropenia | Blood and lymphatic system disorders | 3 of 17 | 0 of 11 | 0 of 1 |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | 3 of 17 | 0 of 11 | 0 of 1 |
| Pyrexia | General disorders | 1 of 17 | 1 of 11 | 0 of 1 |
| Diarrhea | Gastrointestinal disorders | 1 of 17 | 1 of 11 | 0 of 1 |
| Candida pneumonia | Infections and infestations | 1 of 17 | 0 of 11 | 0 of 1 |
| Herpes zoster | Infections and infestations | 0 of 17 | 1 of 11 | 0 of 1 |
| Infection | Infections and infestations | 1 of 17 | 0 of 11 | 0 of 1 |
Most frequent non-serious adverse event terms
| Event term | Organ system | 2000 mg Ofatumumab + DR | 2000 mg Ofatumumab + BFR | 2000 mg Ofatumumab + Other |
|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | 4 of 17 | 5 of 11 | 1 of 1 |
| Cough | Respiratory, thoracic and mediastinal disorders | 3 of 17 | 4 of 11 | 1 of 1 |
| Nausea | Gastrointestinal disorders | 5 of 17 | 2 of 11 | 0 of 1 |
| Pyrexia | General disorders | 4 of 17 | 3 of 11 | 0 of 1 |
| Vomiting | Gastrointestinal disorders | 4 of 17 | 2 of 11 | 0 of 1 |
| Chills | General disorders | 1 of 17 | 4 of 11 | 1 of 1 |
| Back pains | Musculoskeletal and connective tissue disorders | 3 of 17 | 3 of 11 | 0 of 1 |
| Abdominal pain | Gastrointestinal disorders | 4 of 17 | 1 of 11 | 0 of 1 |
| Constipation | Gastrointestinal disorders | 1 of 17 | 3 of 11 | 0 of 1 |
| Oedema peripheral | General disorders | 1 of 17 | 3 of 11 | 0 of 1 |
Serious events with the highest arm-level rate: urinary tract infection (100.0%), disease progression (100.0%), pneumonia (18.2%), neutropenia (17.6%), dyspnea (17.6%).
The safety record gives numbers at risk and numbers affected for serious and other adverse events in three labeled groups. In the group titled 2000 mg Ofatumumab + DR, 17 participants were at risk for each category; 11 had a serious adverse event and 15 had another adverse event. In 2000 mg Ofatumumab + BFR, 11 were at risk; 10 had a serious adverse event and 11 had another adverse event. In 2000 mg Ofatumumab + Other, 1 was at risk; 1 had a serious adverse event and 1 had another adverse event.
These counts are descriptive. The group labels are not established as randomized comparison arms, and DR, BFR, and Other are not defined in the registry record. The groups also differ in size, so their counts should not be read as a controlled comparison of safety. The record lists no death counts; death figures are not reported in the registry record.
Serious-event terms are shown with percentages: urinary tract infection and disease progression at 100.0% each, pneumonia at 18.2%, neutropenia and dyspnea at 17.6% each, and bronchopneumonia at 11.8%. The registry does not clarify the denominators or event-counting rules for these term-specific percentages. They should not be interpreted as treatment-caused events, nor should the percentages be compared across terms without that context.
12. What the Result Does, and Does Not, Mean
The record can establish how the trial was organized and how the primary response endpoint was defined. It describes a completed phase 4, single-group study of ofatumumab retreatment and maintenance in patients with CLL who had previously responded or had stable disease after ofatumumab in Hx-CD20-406. It also records a regimen and several safety counts.
It cannot establish the observed primary response result from the information reported. Although the endpoint title refers to responders and non-responders, the corresponding totals are not reported in the registry record. The response definition therefore tells readers what would count as a response, but it does not tell them how many participants met that definition. No response rate, treatment-effect estimate, or confidence interval should be inferred.
The single-group design also means that the record does not provide a randomized comparison against another treatment or a control condition. Even if outcome totals were available, a within-group result would not by itself distinguish the effect of treatment from other explanations. The safety groups should not be treated as randomized controls: their labels are not fully explained, and the registry does not describe them as like-for-like comparison groups.
The serious and other adverse-event counts indicate how many participants in each listed category were recorded as affected. They do not establish that ofatumumab caused an event. Likewise, the listed term percentages are not enough to determine comparative risk because their denominators and counting rules are not reported in the registry record.
The appropriate reading is therefore narrow: this registry describes a treatment strategy, a selected population, an objective-response definition, and descriptive safety summaries. It does not provide the primary efficacy totals or the analysis detail needed for a complete assessment of efficacy, uncertainty, missing data, or comparative safety. These limitations concern what can be concluded from the registry record, not whether the treatment is appropriate for an individual patient.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of why endpoint definitions and outcome reporting are distinct. The registry gives a detailed rule for classifying objective response, including the categories that count as response and the requirement for confirmation at consecutive visits. Yet the responder and non-responder totals are not reported in the registry record. A precise definition makes an endpoint interpretable, but readers still need the observed data to assess the result.
The study also illustrates the limits of a single-group design. Retreatment was studied among participants selected by prior response or stable disease after ofatumumab. That history defines a specific population and does not create a control group. The observed outcomes, if reported, would describe that enrolled group, while causal comparison with another strategy would require stronger comparative evidence than this design supplies.
Safety summaries raise a related issue: counts need context. The registry lists affected participants and numbers at risk, but the safety group labels are not fully defined and are not presented as randomized arms. Term-specific percentages are also listed without sufficient denominator and counting details. Statistical interpretation depends not only on the numerical value, but also on who was counted, how events were defined, and how observations were handled.
Finally, the record lists several secondary outcomes but does not report the multiplicity strategy, missing-data methods, interim-analysis procedures, or a full statistical analysis plan. These are not minor technical details: they help establish how estimates were generated and how much confidence to place in patterns across outcomes. The trial therefore highlights the value of complete results and analysis documentation alongside clear endpoint definitions.
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 for interpreting efficacy is that the registry record does not report the primary endpoint’s responder and non-responder counts. The primary response definition and assessment period are available, but the result itself is not. The listed secondary outcomes likewise do not include results in the registry record, so their estimates and precision cannot be assessed.
The single-group design has no randomized comparator, limiting the ability to separate treatment-associated outcomes from the influence of prior treatment history, participant selection, and the course of disease. The population was specifically composed of patients who had previously responded or had stable disease after ofatumumab in Hx-CD20-406. The findings, even if fully reported, would apply most directly to a population with that stated treatment history.
The safety summaries require caution. The registry labels groups 2000 mg Ofatumumab + DR, 2000 mg Ofatumumab + BFR, and 2000 mg Ofatumumab + Other but does not define those abbreviations. The record does not report death counts, and it does not clarify denominators or counting rules for the listed serious-event-term percentages. These gaps prevent confident comparative interpretation of the safety summaries.
Other design and analysis details are also absent: the registry record does not report the sample-size justification, interim-analysis procedures, complete statistical analysis plan, multiplicity adjustment, missing-data methods, or analysis-specific populations beyond the Full Analysis Set description. It notes that some participants were not evaluable because of withdrawal, refusal, non-trial drug-related adverse events, and death, but does not provide counts by reason or the handling method. These omissions limit assessment of precision, robustness, and the consequences of incomplete outcome data.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Efficacy and Safety of Ofatumumab Retreatment and Maintenance Treatment in Patients With B-cell Chronic Lymphocytic Leukemia (CLL) — NCT00802737.
- Registry record last updated 2014-05-14; status last verified 2014-04.
- Results first posted 2012-06-26.
- 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
NCT00802737 is a completed phase 4, single-group, unmasked trial sponsored by GlaxoSmithKline. It enrolled 29 participants with CLL who had previously responded or had stable disease after ofatumumab in Hx-CD20-406. The regimen began with eight once-weekly infusions, followed by monthly maintenance for two years.
The primary endpoint classified participants as responders or non-responders under the National Cancer Institute Working Group 1996 guidelines, from treatment start at Week 0/Visit 2 until Week 52. The registry record does not report the primary response totals. It lists secondary outcomes spanning response duration, survival and treatment timing, tumor-size change, and human anti-human antibody results.
Safety counts are reported for three labeled groups, but the labels are not fully defined and do not form a randomized comparison. The record does not report the full statistical plan, missing-data methods, multiplicity strategy, or sample-size justification. The available registry information supports a description of the design and endpoint criteria, but not a complete assessment of efficacy or comparative safety.