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 Safety and Efficacy Study of Iodine-131 Anti-B1 Antibody Plus CHOP For Untreated Mantle Cell Lymphoma (NCT00992992), a na phase 2 study. The primary outcome is Number of Participants With the Indicated Unconfirmed Response (Complete Response, Complete Response Unconfirmed, and Partial Response).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00992992 |
| Phase | Phase 2 |
| Condition | Lymphoma, Mantle-Cell |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 25 |
| Arms in the primary outcome | n/a |
| Lead sponsor | GlaxoSmithKline |
| Results posted | Yes |
2. Clinical Question
Population
Participants with previously untreated mantle cell lymphoma were the intended study population. The registry describes the primary analysis population as participants who received any iodine I-131 tositumomab or CHOP treatment and were evaluable for response, meaning they had at least one response assessment. The record lists enrollment of 25, but does not report how many participants met that response-analysis definition.
Intervention
The intervention was sequential treatment with tositumomab and iodine I-131 tositumomab followed by CHOP. The brief summary describes iodine-131 Anti-B1 Antibody followed by six cycles of CHOP. The registry also lists assessment of total body residence time after the dosimetric dose and safety outcomes related to treatment.
Comparator
No concurrent comparator group is described. The trial is recorded as single-group, with allocation marked NA and masking recorded as none. Consequently, the posted record does not offer a like-for-like control comparison for separating treatment effects from the natural course of disease, participant selection, or other influences.
Primary question
The brief summary identifies duration of response as the primary efficacy endpoint. The registry’s listed primary outcome instead counts participants with an unconfirmed response, including complete response, complete response unconfirmed, and partial response. The record does not report the response count or response duration result. The precise primary question therefore cannot be resolved from the posted outcome information alone.
These distinctions matter because response occurrence and response duration are different quantities. A response count describes whether participants met response criteria; duration describes how long a response persisted under the stated assessment approach. The registry lists follow-up for response assessments every 13 weeks up to 2 years, or every 6 months until disease progression or death, with an average of 77.8 months. That schedule describes observation, but without participant-level follow-up information or outcome estimates it does not establish how long responses lasted.
The study also planned to examine confirmed response, confirmed complete response, progression-free survival, time to treatment failure, and safety. Those aims provide context for the clinical question, but the registry record does not report the numerical efficacy findings needed to describe those outcomes. The trial can therefore be characterized from its design and listed objectives, while the magnitude and precision of its efficacy results remain unavailable in the record.
3. Trial Design
This was a Phase II, single-group study of tositumomab and iodine I-131 tositumomab followed by CHOP in previously untreated mantle cell lymphoma. The registry records enrollment of 25 and the study status as completed. Allocation is marked NA, and masking is recorded as none. No concurrent control arm is described, so the study is not a randomized comparison and its treatment group cannot be interpreted as a like-for-like control against another regimen.
The brief summary describes sequential administration of iodine-131 Anti-B1 Antibody followed by six cycles of CHOP. The intervention listing names tositumomab and iodine I 131 tositumomab followed by CHOP. These descriptions refer to the study regimen as recorded; the registry does not give further operational detail about how treatment decisions or dose adjustments were made. Such details are not reported in the registry record.
The stated primary efficacy objective in the brief summary is duration of response. The outcome listing identifies a primary measure as the number of participants with an indicated unconfirmed response, with complete response, complete response unconfirmed, and partial response included. This difference in how the primary endpoint is described should be kept visible when interpreting the record. It does not supply a response result or explain how the discrepancy arose.
The registry lists 17 outcome measures and 3 analyses. Secondary outcomes include response counts and duration measures for response categories, progression-free survival, time to treatment failure, and participants with any adverse event or serious adverse event. Safety objectives in the brief summary also include hematologic toxicity, supportive care, HAMA positivity, effects on hematopoietic progenitor cells, and survival. Numerical results for many of these objectives are not reported in the registry record.
The study start is recorded as 2001-06-28 and primary completion as 2013-06-30. These dates describe the registry timeline, not the duration of treatment or the follow-up experienced by any individual participant. A sample-size justification, interim-analysis plan, and detailed statistical analysis plan are not reported in the registry record.
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 | Iodine I-131 Tositumomab + CHOP |
|---|---|
| STARTED | 25 |
| COMPLETED | 0 |
| NOT COMPLETED | 25 |
Reasons for not completing this period:
| Reason | Iodine I-131 Tositumomab + CHOP |
|---|---|
| Lost to Follow-up | 3 |
| Death | 16 |
| GlaxoSmithKline Closed the Study | 2 |
| Sponsor Closed the Study | 4 |
Analysis population for the primary outcome, as defined in the registry: ITT-Exposed Population: all participants who received any iodine I-131 tositumomab or CHOP treatment. Only those participants evaluable for response (those with at least one response assessment) were analyzed.
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 | Iodine I-131 Tositumomab + CHOP |
|---|---|---|
| Participants analysed | 25 | |
| Age, Continuous | Years | 64.4 (SD 9.6) |
| Sex: Female, Male: Female | Participants | 2 |
| Sex: Female, Male: Male | Participants | 23 |
| Race/Ethnicity, Customized: White | participants | 24 |
| Race/Ethnicity, Customized: Hispanic | participants | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With the Indicated Unconfirmed Response (Complete Response, Complete Response Unconfirmed, and Partial Response), measured over Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months).
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary outcome listing measures the number of participants with an indicated unconfirmed response. Its response categories are complete response, complete response unconfirmed, and partial response. The registry describes complete response as disappearance of detectable clinical and radiographic evidence of disease and disease-related symptoms. Complete response unconfirmed allows specified residual lymph node mass or indeterminate bone marrow findings. Partial response requires a stated reduction in measurable lesions without new lesions. These criteria define what the response count is intended to represent.
A response count is useful as a direct summary of how many evaluable participants met the stated categories. It does not, on its own, describe how long a response lasted. Duration of response is a separate time-to-event measure and appears in the brief summary as the primary efficacy endpoint, while the outcome listing identifies the response count as primary. The registry record does not explain this difference.
The response outcome was assessed every 13 weeks up to 2 years, or every 6 months until disease progression or death; the listed average is 77.8 months. The analysis population is described as the ITT-Exposed Population: participants who received any iodine I-131 tositumomab or CHOP treatment, restricted to those evaluable for response through at least one assessment. The denominator and response count for that analysis are not reported in the registry record.
In general, response outcomes are clinically interpretable only in relation to their definition, assessment schedule, analysis population, and uncertainty. Here, the definitions and schedule are available, but the numerical result and its precision are not reported in the registry record. The endpoint description therefore clarifies what was meant to be counted, not how many participants responded.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry describes the study design and its outcomes of interest, but it does not provide the numerical result for the listed primary response measure. The number of participants in each response category, the response-analysis denominator, and an estimate of response duration are not reported in the registry record. The posted information therefore supports description of the planned question, not a conclusion about the observed frequency or persistence of response.
There is also a difference between the primary endpoint in the brief summary and the primary outcome listing. The brief summary says the primary efficacy endpoint is duration of response. The registry outcome listing names the number of participants with an indicated unconfirmed response. These are not interchangeable measures. A count indicates whether participants met response criteria; duration concerns the time a response remains in effect under a defined follow-up and censoring approach. The record does not explain the difference or provide either numerical result.
The study is single-group, with no allocation to a concurrent control and no masking recorded. In general, an outcome observed in a single group cannot by itself distinguish the effects of treatment from other explanations, including disease course, participant characteristics, supportive care, or how outcomes were assessed. This design can describe experience among treated participants, but the registry does not support a controlled estimate of comparative effect.
The registry records enrollment of 25. That total is not necessarily the denominator for the primary response outcome: the stated population includes only participants who received treatment and had at least one response assessment. The number meeting those criteria is not reported in the registry record. The same caution applies to safety: the serious adverse event and any adverse event figures use 25 participants at risk, but those safety counts do not provide the missing efficacy denominator or response result.
Some safety findings are reported. The record lists 19 participants with a serious adverse event among 25 at risk and 25 participants with an adverse event among 25 at risk. Specific serious-event terms and percentages are also listed. These figures describe events recorded in this study; they do not establish that treatment caused every event, and they do not supply a comparison with another regimen. No death count is reported in the registry record.
Precision cannot be assessed for the primary response result because no response estimate or interval is reported. In general, a confidence interval describes the range of values compatible with the data under the specified method; without the estimate, denominator, and interval, the uncertainty around the response result cannot be evaluated. The registry’s follow-up schedule and average follow-up do not substitute for an outcome estimate or a description of censoring.
The record also lists sample-size planning illustrations based on stated assumptions. Such calculations are planning tools rather than observed trial outcomes. They cannot fill in the missing response findings, and they do not establish what the study was capable of detecting in practice. No efficacy conclusion should be drawn from enrollment alone or from the fact that the study is marked completed.
9. Statistical Methods Explained
The statistical information can be read in layers: what kind of study was conducted, what outcome was intended to be measured, which participants were included in that outcome analysis, and whether a numerical estimate and its uncertainty were reported. The registry identifies a Phase II, single-group design with no masking recorded. Since there is no concurrent comparison group, the outcome description is not a randomized contrast between treatment strategies.
What does a response count represent?
The listed primary measure is a count of participants meeting response criteria. It combines complete response, complete response unconfirmed, and partial response. A count is a binary-outcome summary at the participant level: each person either meets the specified response definition or does not. In general, such a count is often presented with a denominator and a proportion to show how common the outcome was in the analyzed group. The registry record does not report the response count or denominator, so neither a proportion nor its precision can be described.
The response definitions are clinically structured rather than interchangeable labels. Complete response requires disappearance of detectable clinical and radiographic disease and disease-related symptoms. Complete response unconfirmed permits the specified residual lymph node mass or indeterminate bone marrow condition. Partial response requires at least the stated reduction in measurable lesions and no new lesions. A reader should retain these distinctions when considering what the combined response category includes; the outcome title alone does not mean every included response was a confirmed complete response.
Why does the endpoint description matter?
The brief summary calls duration of response the primary efficacy endpoint, but the listed primary outcome is a participant count for unconfirmed response. In general, a count and a duration measure answer different questions. A count concerns occurrence by the assessment criteria. Duration concerns time from a defined starting point until a specified event, often requiring rules for censoring participants whose outcome is not observed during follow-up. The registry gives no numerical duration result and does not report the statistical details needed to interpret a duration analysis. The difference in endpoint descriptions is not explained in the registry record.
The stated assessment schedule is every 13 weeks up to 2 years, or every 6 months until disease progression or death, with an average of 77.8 months. In general, assessment timing affects when a response can be documented and how long-term outcomes are observed. A listed schedule alone does not show whether every participant followed it, when each response occurred, or how missing assessments were handled. Those details are not reported in the registry record.
How should the analysis population be understood?
The registry describes an ITT-Exposed Population consisting of participants who received any iodine I-131 tositumomab or CHOP treatment, with only those evaluable for response analyzed. Response evaluability is defined as having at least one response assessment. This is not the same as including every enrolled participant regardless of treatment or assessment. The number of participants who were exposed and evaluable is not reported in the registry record. Without that denominator, the listed enrollment of 25 cannot be used to reconstruct the response result.
In general, an analysis population determines whose outcomes contribute to an estimate and can affect its interpretation. Excluding participants without a response assessment may matter if the availability of assessments is related to health status or outcome. The record does not report the reasons for missing assessments, the amount of missing response information, or any method used to address missing data. It is therefore not possible to judge how missingness may have affected the response analysis.
What can the safety counts show?
The safety listing gives participants at risk and affected for serious adverse events and for other adverse events. For the listed treatment group, 19 of 25 participants at risk had a serious adverse event, while 25 of 25 participants at risk had an adverse event. In general, a participant count describes how many people experienced at least one event in the reported category; it does not necessarily describe the number of event episodes. Nor does it establish causation. The registry lists serious-event terms and percentages, but the record does not provide a comparator group for estimating excess risk.
Serious adverse events and any adverse events are different reporting groupings. The former concerns events classified as serious, while the latter is broader. A person may be represented in more than one event term, so the terms should not be added to infer a number of affected participants. The record reports no death count. The listed event percentages should be read as reported and not treated as mutually exclusive categories.
What do planning calculations mean?
The sample-size planning illustration is described as based on the observed effect, with two-sided significance level 0.05, equal allocation between two arms, and a normal approximation. The stated fraction of the observed effect defines the planning effect to detect. For time-to-event outcomes, the illustration gives a total number of events using the Schoenfeld approach; other outcomes are expressed as participants per arm. These are hypothetical planning quantities, not trial observations. They are not observed power and do not show that this single-group study had a comparator or used those assumptions in its original design.
In general, a planning calculation estimates the amount of information that might be needed under chosen assumptions. Its result depends on those assumptions and does not guarantee a particular finding. The registry says the illustration is not the trial’s own design. The sample-size justification and original statistical analysis plan are not reported in the registry record, so the planning display cannot be treated as evidence of the sponsor’s planned analysis.
What is missing for a full statistical appraisal?
The record lists 17 outcome measures and 3 analyses, but it does not report a detailed analysis plan, multiplicity adjustment, interim analyses, confidence intervals for the primary response outcome, or the handling of missing outcome data. In general, multiplicity refers to the increased chance of a chance-positive result when many hypotheses are assessed. Whether and how that concern was addressed depends on a prespecified strategy. That strategy is not reported in the registry record, so no claim can be made about adjustment or control of error rates. These omissions limit assessment of the strength and precision of the efficacy evidence.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 17 outcome measures and 3 analyses, including response categories, response duration, progression-free survival, time to treatment failure, and safety outcomes. Assessing multiple outcomes can create multiplicity concerns. In general, if many statistical questions are tested, the chance of at least one apparently positive finding due to random variation can increase. A prespecified hierarchy or adjustment may address this issue, but the registry record does not report a multiplicity strategy. It is not possible to determine whether the outcomes were formally ranked or adjusted.
The record also does not report interim analyses or a detailed statistical analysis plan. Those details are not reported in the registry record. The brief summary and primary outcome listing differ in their description of the primary endpoint: duration of response versus a count of participants with an indicated unconfirmed response. The record does not explain whether the endpoint description changed or how analyses were selected and reported.
For response, the analysis population includes treated participants with at least one response assessment. The number meeting this definition, the number with missing assessments, and the reasons for missingness are not reported in the registry record. In general, missing outcome data can affect an estimate when the likelihood of having an assessment is related to outcome status. The record does not describe imputation, sensitivity analyses, or another approach to missing data.
The registry lists enrollment of 25, but enrollment alone does not establish the denominator used for each analysis. The efficacy denominator is not reported, and the posted record does not give response estimates or confidence intervals. Accordingly, neither the potential impact of missing response data nor the precision of the efficacy result can be assessed from the registry record. Safety figures are reported with 25 participants at risk, but those figures do not resolve the missing efficacy information.
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 |
|---|---|---|---|
| Iodine I-131 Tositumomab + CHOP | 19 | 25 | 76.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Iodine I-131 Tositumomab + CHOP | 25 of 25 |
Most frequent serious adverse event terms
| Event term | Organ system | Iodine I-131 Tositumomab + CHOP |
|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | 7 of 25 |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 2 of 25 |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 2 of 25 |
| Neutropenia | Blood and lymphatic system disorders | 2 of 25 |
| Endometrial adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 25 |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 25 |
| Malignant melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 25 |
| Oesophageal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 25 |
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 25 |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 25 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Iodine I-131 Tositumomab + CHOP |
|---|---|---|
| Fatigue | General disorders | 21 of 25 |
| Constipation | Gastrointestinal disorders | 12 of 25 |
| Nausea | Gastrointestinal disorders | 12 of 25 |
| Neuropathy peripheral | Nervous system disorders | 10 of 25 |
| Platelets <50000 cells/millimeters cubed (mm^3) | Investigations | 10 of 25 |
| WBC < 2000 cells/mm^3 | Investigations | 10 of 25 |
| Pyrexia | General disorders | 9 of 25 |
| Diarrhoea | Gastrointestinal disorders | 9 of 25 |
| Headache | Nervous system disorders | 7 of 25 |
| Cough | Respiratory, thoracic and mediastinal disorders | 7 of 25 |
Serious events with the highest arm-level rate: febrile neutropenia (28.0%), basal cell carcinoma (8.0%), myelodysplastic syndrome (8.0%), neutropenia (8.0%), endometrial adenocarcinoma (4.0%).
The safety listing reports 19 participants with a serious adverse event among 25 at risk in the Iodine I-131 Tositumomab + CHOP group. It also reports 25 participants with any adverse event among 25 at risk. These are participant counts for different event groupings: serious adverse events are a subset of the broader any-adverse-event category, not a separate treatment comparison.
The registry lists febrile neutropenia at 28.0% as a serious adverse event term. Basal cell carcinoma, myelodysplastic syndrome, and neutropenia are each listed at 8.0%; endometrial adenocarcinoma and malignant melanoma are each listed at 4.0%. These are reported term-specific percentages. Event terms can overlap within participants, so the percentages should not be added or interpreted as separate groups of people.
In general, adverse-event listings describe events observed and recorded during a study; a listing alone does not establish that the intervention caused each event. The single-group design offers no concurrent control for comparison, and the registry does not report a death count. The record also does not provide enough detail to assess event timing, duration, severity beyond the stated serious classification, or attribution for each event. The figures describe the reported safety experience, not a comparative estimate of harm.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a completed Phase II, single-group study evaluated tositumomab and iodine I-131 tositumomab followed by CHOP in previously untreated mantle cell lymphoma. It describes response criteria, the response-assessment schedule, the intended analysis population, and selected safety findings. It does not report the numerical result for the listed primary response outcome or the duration-of-response estimate identified in the brief summary. The central efficacy finding therefore cannot be characterized from the posted record.
The absence of a response result is not evidence that no responses occurred, just as a completed study is not evidence that its primary objective was met. Without the response count, analysis denominator, and uncertainty estimate, the frequency and precision of response cannot be evaluated. The record also does not provide a comparative estimate because it describes no concurrent control group.
The mismatch between the brief summary’s duration-of-response endpoint and the listed primary response-count outcome is important for interpretation. A response count and a response-duration analysis answer different questions. The registry does not explain the distinction or provide numerical findings for either measure. Readers should not treat the description of an endpoint as a result.
The safety listing does show that serious and any adverse events were recorded, with participants affected and particular serious-event terms reported. Those observations should not be read as proof that every event was caused by treatment, nor as a comparison of safety against another option. The study design and missing attribution details limit those conclusions.
In general, a study result is most informative when the estimate, denominator, uncertainty, analysis population, and method are all clear. Here, important design details are present, but key efficacy values and details of missing-data and multiplicity handling are not reported in the registry record. The evidence described should therefore be limited to the study structure and the posted safety counts; it does not support a conclusion about treatment benefit, lack of benefit, or comparative safety.
13. Why This Trial Matters Statistically
This trial illustrates why registry interpretation requires attention to the specific outcome definition rather than relying only on a brief summary. The brief summary names duration of response as the primary efficacy endpoint, while the outcome listing identifies a response count as primary. These measures have different meanings, and the registry record does not explain the difference. Recognizing that distinction prevents an outcome definition from being mistaken for an observed result.
The record also shows why the analysis population matters. Enrollment is listed as 25, but the response analysis is described as limited to treated participants with at least one assessment. Without the response-analysis denominator and count, the efficacy result cannot be reconstructed. The safety population figures cannot be substituted for that missing response denominator.
Design is equally important. A single-group study can describe outcomes observed among treated participants, but it has no concurrent control for a direct comparison. In general, without such a comparison, observed outcomes may reflect influences beyond the intervention. This limits causal and comparative interpretation, regardless of how carefully the response criteria are specified.
Finally, the record lists many outcomes but does not report a multiplicity strategy, missing-data approach, interim analyses, or detailed statistical plan. These omissions prevent a full assessment of how estimates were selected, how uncertainty was handled, and whether outcome-level analyses were prespecified. The sample-size illustration is explicitly a planning calculation rather than the trial’s own design and should not be confused with observed power or evidence of treatment effect.
These issues are useful beyond this study: they demonstrate that a clear statistical reading separates study aims, recorded outcomes, analysis populations, observed findings, and causal claims. In this record, the design and some safety figures are described, but the central efficacy result is not reported.
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 for interpreting efficacy is the absence of numerical results for the primary outcome as listed. The response count, denominator, and duration-of-response estimate are not reported in the registry record. This prevents assessment of the observed response frequency, duration, or precision. The brief summary and outcome listing also identify different primary efficacy measures, and the record does not explain that discrepancy.
The single-group design has no concurrent comparison. Allocation is marked NA and masking is recorded as none. Consequently, the record does not support a direct comparison with another treatment, and observed outcomes cannot be separated from other influences through a controlled contrast. The enrollment figure of 25 does not establish the number evaluable for response, because the stated response population requires treatment exposure and at least one response assessment.
The registry does not report the amount or reasons for missing response data, any method for handling missingness, confidence intervals for the primary response result, or sensitivity analyses. It also does not report a detailed statistical analysis plan, multiplicity adjustment, or interim-analysis plan. These details are needed to evaluate how robust and precise the efficacy findings would be, but they are not reported in the registry record.
Safety interpretation is limited as well. The record lists serious and any adverse-event participant counts and selected serious-event terms, but a comparator is absent. Attribution, timing, and death count are not reported in the registry record. The event-term percentages should not be combined because participants may contribute to more than one term.
Finally, the sample-size material is described as a planning illustration rather than the original study design. It cannot establish the study’s actual statistical plan or observed power. Taken together, these limitations mean that the registry supports description of design and some safety observations, but not a complete statistical appraisal of efficacy or comparative safety.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Safety and Efficacy Study of Iodine-131 Anti-B1 Antibody Plus CHOP For Untreated Mantle Cell Lymphoma — NCT00992992.
- Registry record last updated 2019-12-04; status last verified 2019-11.
- Results first posted 2014-04-08.
- 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
NCT00992992 is a completed Phase II, single-group study of tositumomab and iodine I-131 tositumomab followed by CHOP for previously untreated mantle cell lymphoma. The registry records enrollment of 25, no masking, and allocation marked NA. The study start is 2001-06-28, and primary completion is 2013-06-30.
The brief summary identifies duration of response as the primary efficacy endpoint, while the listed primary outcome counts participants with an indicated unconfirmed response. The outcome population is described as treated participants with at least one response assessment. The response result, its denominator, and duration estimates are not reported in the registry record.
The safety listing reports 19 participants with a serious adverse event among 25 at risk and 25 participants with an adverse event among 25 at risk. The record lists 17 outcome measures and 3 analyses. A detailed statistical plan, missing-data approach, multiplicity strategy, and death count are not reported in the registry record.