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 A Study for Patients With Non-Hodgkin's Lymphomas (NCT00542919), a non-randomized phase 2 study. The primary outcome is Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00542919 |
| Phase | Phase 2 |
| Condition | T-Cell Lymphoma, B-Cell Lymphoma |
| Allocation | Non-Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 57 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Eli Lilly and Company |
| Results posted | Yes |
2. Clinical Question
Population
Participants had T-cell lymphoma, indolent B-cell lymphoma, or aggressive B-cell lymphoma. The specified subtypes included peripheral and cutaneous T-cell lymphoma; small lymphocytic, follicular Grade 1 or 2, and marginal zone lymphoma; and primary CNS lymphoma, follicular Grade 3a or 3b, and aggressive lymphoma with a prior clinical history of indolent lymphoma. The primary endpoint population was participants with all tumor subtypes who received at least one dose of study drug and had evaluable tumor response data.
Intervention
Participants received enzastaurin. The group descriptions specify a 1125 mg loading dose followed by 500 mg orally daily, until progressive disease or predefined discontinuation criteria were met. The study was open-label, so treatment masking was absent.
Comparator
There was no comparator drug. The study was nonrandomized and noncomparative; its three groups were defined by lymphoma type rather than by assignment to enzastaurin versus a control treatment.
Primary question
The primary endpoint asked what percentage of treated participants in each tumor subtype had a complete response, complete response unconfirmed, or partial response. The registry record defines response using subtype-specific criteria. It does not report the numerical response rate or confidence interval, so the endpoint’s estimated result and precision are not reported in the registry record.
In statistical terms, the study describes tumor response during treatment with enzastaurin across a set of lymphoma subtypes. Its noncomparative design can describe outcomes among participants who received the drug, but it does not estimate a treatment contrast against an untreated or alternative-treatment group. Because the tumor types and response criteria vary, interpretation needs to keep the disease groups and their assessment rules in view rather than treating the whole sample as a single uniform population. The registry record lists an overall enrollment of 57, but does not give the primary response results by group or subtype.
3. Trial Design
This was a Phase 2, multicenter, open-label, noncomparative study of enzastaurin in participants with non-Hodgkin’s lymphomas. It was nonrandomized, with no masking and no comparator drug. The registry record lists a parallel model and overall enrollment of 57. The study status is completed; the recorded start is 2007-11 and primary completion is 2010-03.
The treatment groups were organized by tumor type: T-cell lymphoma, indolent B-cell lymphoma, and aggressive B-cell lymphoma. These are disease categories, not randomized treatment arms. The group descriptions specify an enzastaurin 1125 mg loading dose followed by 500 mg orally each day, with treatment continuing until progressive disease or predefined criteria for discontinuation. Details beyond that description, including the full criteria and the handling of participants who progressed early, are not reported in the registry record.
The primary outcome was tumor response rate, defined by complete response, complete response unconfirmed, or partial response. The stated timeframe was baseline to measured progressive disease, up to 114 months. Secondary outcomes included progression-free survival, time to progressive disease, duration of response, progression-free survival at 1-Year, and participants with one or more drug-related adverse events. The registry record lists six outcome measures, but does not provide numerical results for these secondary outcomes.
A nonrandomized, noncomparative design can characterize observed outcomes within the treated population. It does not, by itself, separate treatment effects from the natural course of disease, participant characteristics, or other influences. Open-label conduct also means masking was not used. Whether any independent outcome review, formal sample-size justification, or interim analysis was planned is not reported in the registry record. The record does not give detailed analysis methods for the outcome measures.
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: Completers include participants who had progressive disease, died due to any cause or alive and on study at the end of study, but off treatment.
Overall Study
| Stage | T-Cell (TCL) | Indolent B-Cell (IBCL) | Aggressive B-Cell (ABCL) |
|---|---|---|---|
| STARTED | 23 | 19 | 15 |
| Received At Least One Dose of Study Drug | 23 | 19 | 15 |
| Progressive Disease | 15 | 11 | 7 |
| Death | 1 | 1 | 2 |
| COMPLETED | 16 | 12 | 9 |
| NOT COMPLETED | 7 | 7 | 6 |
Reasons for not completing this period:
| Reason | T-Cell (TCL) | Indolent B-Cell (IBCL) | Aggressive B-Cell (ABCL) |
|---|---|---|---|
| Adverse Event | 1 | 5 | 1 |
| Withdrawal by Subject | 1 | 0 | 3 |
| Physician Decision | 2 | 2 | 1 |
| Sponsor Decision | 1 | 0 | 0 |
| Lost to Follow-up | 2 | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: All participants with all tumor subtypes, who received at least one dose of study drug, and had evaluable tumor response rate data.
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: All participants who received at least one dose of study drug.
| Characteristic | Unit | T-Cell | Indolent B-Cell | Aggressive B-Cell | Total |
|---|---|---|---|---|---|
| Participants analysed | 23 | 19 | 15 | 57 | |
| Age, Continuous | years | 49.3 (SD 17.54) | 69.7 (SD 10.46) | 60.1 (SD 8.44) | 58.9 (SD 15.9) |
| Sex: Female, Male: Female | Participants | 12 | 5 | 7 | 24 |
| Sex: Female, Male: Male | Participants | 11 | 14 | 8 | 33 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 18 | 8 | 11 | 37 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 5 | 11 | 4 | 20 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 1 | 1 |
| Race (NIH/OMB): Black or African American | Participants | 2 | 0 | 0 | 2 |
| Race (NIH/OMB): White | Participants | 9 | 17 | 12 | 38 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 12 | 2 | 2 | 16 |
| Region of Enrollment: United States | Participants | 1 | 1 | 1 | 3 |
| Region of Enrollment: Brazil | Participants | 7 | 2 | 3 | 12 |
| Region of Enrollment: Mexico | Participants | 9 | 6 | 7 | 22 |
| Region of Enrollment: Australia | Participants | 1 | 9 | 2 | 12 |
| Region of Enrollment: Peru | Participants | 5 | 0 | 0 | 5 |
| Region of Enrollment: Argentina | Participants | 0 | 1 | 2 | 3 |
6. Primary Endpoint
The registry lists the primary outcome as Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]), measured over Baseline to Measured Progressive Disease (Up to 114 Months).
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | percentage of participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the percentage of participants who experienced a tumor response, with response defined as complete response, complete response unconfirmed, or partial response. The registry description defines the rate as responders divided by treated participants for the relevant tumor subtype. Its endpoint population is described as participants with any tumor subtype who received at least one dose of study drug and had evaluable tumor response data. The recorded timeframe runs from baseline to measured progressive disease, up to 114 months.
Response criteria differ by disease presentation. For cutaneous T-cell lymphoma, complete response is defined by a modified severity-weighted assessment tool (mSWAT) value of zero, and partial response by an mSWAT value > 50% decrease from baseline. For CNS lymphoma, the record cites complete response, unconfirmed complete response, or partial response criteria attributed to Abrey et al. For other participants, it cites complete response, complete response unconfirmed, or partial response criteria attributed to Cheson et al. These rules matter because the endpoint does not represent one identical measurement procedure across every subtype.
A response rate is a proportion that summarizes how many participants met a prespecified response category. It is often used in a single-group study to describe tumor response without requiring a comparator. It does not measure how long a response lasts or establish what would have happened under another treatment. The registry record gives no numerical response rate or confidence interval, so neither the estimated proportion nor its precision is reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The available registry information establishes the study question and endpoint definition, but does not provide the primary outcome result. The record names tumor response rate as the primary endpoint and describes the response categories, eligible population, and assessment timeframe. It does not report the number or percentage of responders, a confidence interval, or a statistical analysis of that endpoint. Therefore, the magnitude and precision of the primary result are not reported in the registry record.
The study enrolled 57 participants overall, across T-cell, indolent B-cell, and aggressive B-cell lymphoma groups. The safety information lists participants at risk and affected counts within each group, but those figures are not tumor response results. They cannot fill the gap in the primary endpoint reporting. Nor should the overall enrollment be read as the denominator for every outcome: the endpoint definition requires at least one dose and evaluable response data, and group-specific outcome denominators are not reported in the registry record.
The design limits the comparisons that can be made. Since the study was nonrandomized and had no comparator drug, it describes outcomes among participants treated with enzastaurin but does not provide a controlled estimate of how outcomes differ from another treatment or from no study drug. The three lymphoma groups also cover distinct diseases and subtypes, with different response assessment rules in some settings. A combined response estimate, even if reported, would need to be interpreted in light of that clinical and measurement diversity; no such estimate is reported in the registry record.
A confidence interval, when reported, indicates a range of values compatible with the data under the analysis assumptions; narrower intervals generally indicate greater precision. No primary confidence interval values appear in the registry record. A p-value would address compatibility with a specified null hypothesis, not the size or clinical importance of an effect, but a primary-endpoint p-value is also not reported in the registry record. The record lists zero analyses, and does not provide inferential results for the primary outcome.
Safety results are reported separately by disease group. They include counts of participants affected by serious and other adverse events, as well as a list of serious adverse event terms with percentages. Those results describe reported safety events; they do not establish a treatment comparison or explain the primary tumor response endpoint. The registry record’s secondary outcome list includes time-to-event and safety outcomes, but numerical results for those outcomes are not reported in the registry record. Overall, the posted information supports a description of the design and outcome definitions, but not a conclusion about the estimated tumor response or its precision.
9. Statistical Methods Explained
A binary response endpoint classifies each eligible participant according to whether a response occurred. The tumor response rate is the proportion of participants categorized as complete response, complete response unconfirmed, or partial response. This is a direct summary of response status, but it discards distinctions among the included response categories and does not itself describe response duration. The registry record defines the numerator as responders and the denominator as treated participants for the tumor subtype. It separately describes the endpoint population as participants who received at least one dose and had evaluable response data.
What does a confidence interval communicate?
A confidence interval expresses statistical uncertainty around an estimate, such as a response proportion. It reflects the information in the analyzed observations together with the assumptions of the method used. It is not a guarantee that the true value lies in the calculated interval, nor does it account automatically for every possible source of bias. Although the endpoint specifies a 95% confidence interval, its numerical limits are not reported in the registry record. The response estimate itself is also not reported, so its precision cannot be assessed from the registry information.
Why do endpoint definitions differ across subtypes?
The registry describes different response assessment criteria for cutaneous T-cell lymphoma, CNS lymphoma, and other participants. For cutaneous T-cell lymphoma, the specified measures include mSWAT-based complete and partial response definitions. CNS lymphoma uses criteria attributed in the record to Abrey et al.; other participants use criteria attributed to Cheson et al. When a study combines outcomes assessed under different rules, the response categories may not be operationalized in exactly the same way across all participants. Subtype-level results and denominators would help readers understand how the overall result relates to each disease group, but those results are not reported in the registry record.
What does the noncomparative design permit?
In general, a single-group study can estimate outcomes observed among participants who received the study treatment. Without a concurrent comparator, it cannot directly estimate a between-group treatment effect. Nonrandomized allocation also means that treatment assignment does not provide the protections of random allocation against differences in participant characteristics. In this study, the registry record says there was no comparator drug and the study was nonrandomized. It does not report an adjusted comparison or statistical model, and no such comparison should be inferred from the reported design.
The open-label design means participants and study personnel were not masked to treatment. This fact alone does not show that outcome assessment was biased, but the record does not report whether response assessment was performed independently or with blinding. The specific methods for adjudicating response, handling assessments over time, and resolving incomplete or inconsistent measurements are not reported in the registry record.
How should the analysis population be considered?
The endpoint description identifies participants who received at least one dose and had evaluable tumor response data. It does not give the number included in that population, the number excluded, or reasons for exclusion. The treated-participant denominator is specified in the endpoint definition, but the record does not explain how missing response assessments were handled or whether participants without evaluable data were counted as nonresponders. These details can change the interpretation of a proportion, so they should not be assumed.
The registry lists progression-free survival, time to progressive disease, duration of response, progression-free survival at 1-Year, and drug-related adverse events as secondary outcomes. Time-to-event outcomes generally require rules for defining events, censoring, and follow-up. Such rules and the statistical methods for these outcomes are not reported in the registry record. The fact that these outcomes are listed does not establish that numerical analyses are available.
What can planning calculations say?
General sample-size calculations use assumptions about an effect to be detected, a significance level, allocation, and a statistical method. A planning illustration is not an observed trial outcome and is not “observed power.” The recorded planning assumptions describe a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and effect sizes expressed as fractions of the observed effect. The instructions for the illustration distinguish total events for time-to-event outcomes from participants per arm for other outcomes. These are planning assumptions, not evidence that the study itself used that design: the trial was nonrandomized and noncomparative. The study’s own sample-size justification and statistical analysis plan are not reported in the registry record.
Over-dispersion is a general concern when data vary more than a simple statistical model assumes; if ignored, uncertainty may be understated. For a binary response proportion, the relevant analysis depends on the participant-level outcome definition and the denominator. The registry record does not describe use of an over-dispersion adjustment or any other model. No model or additional procedure should be presumed from the endpoint label alone.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one primary endpoint and several secondary outcomes, including progression-free survival, time to progressive disease, duration of response, progression-free survival at 1-Year, and drug-related adverse events. Considering multiple outcomes can raise a multiplicity issue: when many hypotheses are tested, the chance of at least one apparently notable result can increase. A statistical plan may address this by defining a hierarchy, adjusting significance thresholds, or treating analyses as descriptive. The registry record does not report a multiplicity strategy, a hierarchy among secondary outcomes, or which tests, if any, were intended to support formal claims.
The registry describes the primary endpoint population as participants who received at least one dose and had evaluable tumor response data. It does not report how many participants met those criteria, how many lacked evaluable data, or how missing response assessments were handled. It also does not specify whether missing outcomes were excluded, treated as nonresponse, or addressed using another method. Those analysis-population and missing-data procedures are not reported in the registry record.
The endpoint description gives the response denominator as treated participants for each tumor subtype, while the stated population requires evaluable response data. The record does not explain how those descriptions were reconciled in the analysis or provide subtype-specific denominators. It lists six outcome measures and zero analyses, but that does not supply missing-data rules or confirm what analyses were performed. The study’s prespecified statistical analysis plan, including any interim analyses, is not reported in the registry record. Accordingly, the primary and secondary outcome definitions can be described, but the role of missing observations and any multiplicity control cannot be assessed.
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 |
|---|---|---|---|
| T-Cell | 9 | 23 | 39.1% |
| Indolent B-Cell | 11 | 19 | 57.9% |
| Aggressive B-Cell | 5 | 15 | 33.3% |
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 |
|---|---|
| T-Cell | 19 of 23 |
| Indolent B-Cell | 17 of 19 |
| Aggressive B-Cell | 10 of 15 |
Most frequent serious adverse event terms
| Event term | Organ system | T-Cell | Indolent B-Cell | Aggressive B-Cell |
|---|---|---|---|---|
| Pneumonia | Infections and infestations | 1 of 23 | 1 of 19 | 3 of 15 |
| Sepsis | Infections and infestations | 4 of 23 | 1 of 19 | 0 of 15 |
| Anaemia | Blood and lymphatic system disorders | 2 of 23 | 2 of 19 | 0 of 15 |
| Pyrexia | General disorders | 3 of 23 | 1 of 19 | 0 of 15 |
| Non-hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 23 | 2 of 19 | 0 of 15 |
| Diarrhoea | Gastrointestinal disorders | 2 of 23 | 0 of 19 | 0 of 15 |
| Oedema peripheral | General disorders | 2 of 23 | 0 of 19 | 0 of 15 |
| Septic shock | Infections and infestations | 1 of 23 | 1 of 19 | 0 of 15 |
| Hypercalcaemia | Metabolism and nutrition disorders | 1 of 23 | 1 of 19 | 0 of 15 |
| Anaemia of malignant disease | Blood and lymphatic system disorders | 0 of 23 | 0 of 19 | 1 of 15 |
Most frequent non-serious adverse event terms
| Event term | Organ system | T-Cell | Indolent B-Cell | Aggressive B-Cell |
|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | 4 of 23 | 8 of 19 | 3 of 15 |
| Anaemia | Blood and lymphatic system disorders | 5 of 23 | 3 of 19 | 3 of 15 |
| Oedema peripheral | General disorders | 4 of 23 | 3 of 19 | 3 of 15 |
| Pyrexia | General disorders | 6 of 23 | 3 of 19 | 1 of 15 |
| Fatigue | General disorders | 2 of 23 | 7 of 19 | 0 of 15 |
| Cough | Respiratory, thoracic and mediastinal disorders | 3 of 23 | 5 of 19 | 1 of 15 |
| Pruritus | Skin and subcutaneous tissue disorders | 4 of 23 | 3 of 19 | 2 of 15 |
| Headache | Nervous system disorders | 3 of 23 | 4 of 19 | 1 of 15 |
| Nausea | Gastrointestinal disorders | 2 of 23 | 3 of 19 | 2 of 15 |
| Vomiting | Gastrointestinal disorders | 1 of 23 | 4 of 19 | 2 of 15 |
Serious events with the highest arm-level rate: pneumonia (20.0%), sepsis (17.4%), pyrexia (13.0%), anaemia (10.5%), non-hodgkin's lymphoma (10.5%).
The safety information is organized by the three lymphoma groups. For T-Cell, 23 participants were listed at risk for serious adverse events and 9 were affected; 23 were listed at risk for other adverse events and 19 were affected. For Indolent B-Cell, the corresponding counts were 19 at risk and 11 affected for serious events, and 19 at risk and 17 affected for other events. For Aggressive B-Cell, 15 were listed at risk and 5 affected for serious events, and 15 at risk and 10 affected for other events. These are counts, not comparisons between randomized treatments.
The record also lists serious adverse event terms with percentages: Pneumonia, 20.0%; Sepsis, 17.4%; Pyrexia, 13.0%; Anaemia, 10.5%; Non-hodgkin’s lymphoma, 10.5%; and Diarrhoea, 8.7%. The registry information does not give the denominators or further context for these term percentages, so they should be read as reported rather than converted into participant counts. Death counts are not reported in the registry record.
In general, adverse-event counts describe events recorded in the study population; they do not establish that the study drug caused an event. The record includes a secondary outcome for participants with one or more drug-related adverse events, but the listed serious and other event counts do not themselves provide a causal comparison. There is no comparator group, and the safety counts should not be interpreted as evidence of a difference from another treatment.
12. What the Result Does, and Does Not, Mean
The registry record establishes that enzastaurin was studied in participants with T-cell, indolent B-cell, and aggressive B-cell lymphoma in a Phase 2, open-label, nonrandomized, noncomparative design. It defines tumor response as complete response, complete response unconfirmed, or partial response, using criteria that vary by subtype. It also records safety counts for the three disease groups and names secondary outcomes.
Those design and definition details are not numerical evidence of the primary outcome. The record does not report how many participants responded, the response percentage, or its confidence interval. It therefore does not show the size or precision of the tumor response estimate. The overall enrollment of 57 is not a substitute for an outcome denominator, because the response population is specified as participants who received at least one dose and had evaluable response data. Group- and subtype-specific denominators are not reported in the registry record.
Even if a response proportion were available, a single-group, noncomparative study would describe outcomes among treated participants rather than establish a causal difference from another treatment. The design has no comparator drug and no random allocation. Thus it cannot separate a treatment-associated outcome from other possible influences using a randomized between-group contrast. This is a limitation of what the design can estimate, not a claim about the direction or size of any treatment effect.
The safety figures likewise describe recorded events in the study groups, not a comparison against another treatment. Counts of participants affected by serious or other adverse events do not, on their own, establish causation. The record does not report death counts, and the secondary outcome list does not include numerical results for its listed outcomes.
The appropriate interpretation is therefore bounded: the registry record documents the trial structure, endpoint definitions, and selected safety information, but does not report the primary response result or its uncertainty. No conclusion about the magnitude, precision, or comparative effect of tumor response can be drawn from the outcome information recorded there.
13. Why This Trial Matters Statistically
This trial is statistically instructive because its clinical question is framed around a response proportion in a noncomparative treatment study. A response rate can provide a clear descriptive summary for a treated group, but its meaning depends on a defined numerator, an appropriate denominator, and consistent assessment rules. The registry record identifies complete response, complete response unconfirmed, and partial response as qualifying outcomes, while also describing subtype-specific measurement criteria.
The study includes three broad lymphoma groups and multiple subtypes. That diversity makes the analysis population and subgroup reporting important: a single overall proportion could conceal variation across diseases or criteria, while separate subgroup estimates may be less precise. The registry record does not report those response estimates or denominators. This illustrates why an endpoint definition alone is not enough to interpret an effect; the numerical results and their uncertainty are also needed.
The design also makes the distinction between description and comparison central. Participants were not randomized, there was no comparator drug, and the study was open-label. A response proportion can describe outcomes in the treated participants, but without a control group it is not a randomized estimate of treatment benefit relative to another option. Recognizing the estimand—the quantity the analysis aims to describe or compare—helps prevent a descriptive result from being mistaken for a controlled treatment contrast.
Finally, the record lists multiple secondary outcomes, including time-to-event and safety measures, but provides no numerical analyses for them. In general, multiplicity and missing outcome data affect how a set of results should be interpreted. Here, the registry record does not describe the multiplicity plan or missing-data procedures. These gaps highlight why statistical interpretation depends not only on named endpoints, but also on analysis populations, prespecified methods, and complete outcome reporting.
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 principal limitation in interpreting the registry record is that it does not report numerical results for the primary tumor response endpoint. Although the endpoint, timeframe, response definitions, and intended population are described, the response count, percentage, and confidence interval are not reported in the registry record. There is consequently no basis in the record for assessing the observed magnitude or statistical precision of tumor response.
The nonrandomized, noncomparative design does not support a controlled comparison with another treatment. It is also open-label, and the record does not report whether outcome assessment was independently reviewed or masked. The study includes several lymphoma types and subtypes, with different response criteria in some settings. Subtype-specific outcome results and denominators are not reported, limiting assessment of how the groups contribute to any overall estimate.
The record lists overall enrollment as 57 and describes an endpoint population requiring at least one dose and evaluable response data, but it does not state the size of that analysis population or explain missing response data. The handling of early progression, incomplete assessments, and exclusions is not reported in the registry record. Nor are the statistical analysis plan, sample-size justification, interim analyses, multiplicity methods, or detailed models reported.
The listed safety information gives counts by group and selected serious adverse event terms with percentages, but the record does not provide the denominators and context for those term percentages. Death counts are not reported. Numerical results for the secondary outcomes are also not reported in the registry record. These limitations constrain interpretation of efficacy, safety, and precision; they do not establish that an outcome was favorable or unfavorable.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study for Patients With Non-Hodgkin's Lymphomas — NCT00542919.
- Registry record last updated 2020-10-19; status last verified 2020-09.
- Results first posted 2020-10-19.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry record describes NCT00542919, a completed Phase 2 study of enzastaurin in participants with non-Hodgkin’s lymphomas. It was multicenter, open-label, nonrandomized, and noncomparative, with no comparator drug. Overall enrollment was 57. The recorded study start was 2007-11 and primary completion was 2010-03.
Participants were grouped as T-Cell, Indolent B-Cell, or Aggressive B-Cell. The primary endpoint was tumor response rate, defined by complete response, complete response unconfirmed, or partial response under criteria that vary by subtype. The record lists progression-free survival, time to progressive disease, duration of response, progression-free survival at 1-Year, and drug-related adverse events among secondary outcomes.
Group-level serious and other adverse event counts and selected serious event terms are recorded. However, numerical results for the primary response endpoint and the listed secondary outcomes are not reported in the registry record. The endpoint’s numerical estimate, its confidence interval, and relevant response denominators are therefore not available from the registry information.