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 of Participants With Lymphoma Who Take R-CHOP and Enzastaurin Compared to Participants Who Take R-CHOP Only (NCT00451178), a randomized phase 2 study. The primary outcome is Progression-Free Survival (PFS) Time.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00451178 |
| Phase | Phase 2 |
| Condition | Lymphoma |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 101 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Eli Lilly and Company |
| Results posted | Yes |
2. Clinical Question
Population
Participants with intermediate- and high-risk diffuse large B-cell lymphoma receiving first-line treatment. The primary-endpoint population included randomized participants who received at least one dose of enzastaurin or a drug in the R-CHOP regimen and had at least one post-baseline efficacy measurement.
Intervention
R-CHOP plus enzastaurin. R-CHOP comprises rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone.
Comparator
R-CHOP alone, comprising rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone.
Primary question
How did progression-free survival time, measured from randomization to objectively determined disease progression or death from any cause, compare between the two treatment groups?
The clinical question is comparative: the registry record describes a randomized, open-label study of two treatment regimens in first-line care. The primary outcome is time-to-event, rather than a single assessment of whether a participant had progressed by a fixed date. Participants without a recorded progression or death by the data cutoff could be censored under the stated rules.
The record gives median PFS estimates and confidence-interval lower limits for both groups, but it does not report upper confidence limits or sponsor-reported hazard ratios. A complete numerical estimate of the between-group time-to-event contrast is therefore not available in the registry record. The question is whether the observed outcome estimates differ, and how precisely the data estimate that contrast; the posted summaries alone do not establish a causal explanation for any observed difference.
3. Trial Design
This was a randomized, open-label, parallel-group phase 2 study. The registry record reports enrollment of 101 and a completed status. It describes comparison of R-CHOP plus enzastaurin with R-CHOP alone in the first-line treatment of participants with intermediate- and high-risk diffuse large B-cell lymphoma. Because the study was open-label, treatment assignment was not masked according to the record.
The two groups received the same R-CHOP regimen, with enzastaurin added in one group. R-CHOP consisted of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone. The primary outcome was progression-free survival time, defined from randomization to the first objectively determined disease progression or death from any cause. The registry describes follow-up for this endpoint as up to 55 months.
The primary analysis population was not simply all randomized participants. It included those who received at least one dose of enzastaurin or any drug in the R-CHOP regimen and had at least one post-baseline efficacy measurement. The record reports that 34 participants in the R-CHOP/enzastaurin group and 21 in the R-CHOP group were censored for the primary outcome. The safety figures use different at-risk counts, so they should not be treated as the primary-endpoint analysis population.
The registry record does not report the randomization ratio, allocation-concealment procedure, stratification factors, or a detailed account of the statistical analysis plan. It also does not report a sample-size justification or interim-analysis plan. These omissions limit how fully the design and analysis decisions can be assessed from the registry entry.
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: Study included chemotherapy, maintenance therapy (only R-CHOP and enzastaurin treatment arm) and follow-up post treatment for long-term efficacy.
Chemotherapy (Up To Six 21-Day Cycles)
| Stage | R-CHOP and Enzastaurin | R-CHOP |
|---|---|---|
| STARTED | 58 | 43 |
| Received At Least 1 Dose Study Treatment | 57 | 43 |
| COMPLETED | 40 | 26 |
| NOT COMPLETED | 18 | 17 |
Reasons for not completing this period:
| Reason | R-CHOP and Enzastaurin | R-CHOP |
|---|---|---|
| Adverse Event | 6 | 6 |
| Withdrawal by Subject | 4 | 3 |
| Protocol Violation | 2 | 1 |
| Physician Decision | 1 | 2 |
| Death | 4 | 3 |
| Progressive Disease (PD) | 1 | 2 |
Prior to Maintenance Therapy
| Stage | R-CHOP and Enzastaurin | R-CHOP |
|---|---|---|
| STARTED | 40 | 0 |
| COMPLETED | 36 | 0 |
| NOT COMPLETED | 4 | 0 |
Reasons for not completing this period:
| Reason | R-CHOP and Enzastaurin | R-CHOP |
|---|---|---|
| Physician Decision | 2 | 0 |
| PD | 2 | 0 |
Maintenance Therapy (up to 3 Years)
| Stage | R-CHOP and Enzastaurin | R-CHOP |
|---|---|---|
| STARTED | 36 | 0 |
| COMPLETED | 6 | 0 |
| NOT COMPLETED | 30 | 0 |
Reasons for not completing this period:
| Reason | R-CHOP and Enzastaurin | R-CHOP |
|---|---|---|
| Adverse Event | 4 | 0 |
| Withdrawal by Subject | 5 | 0 |
| Physician Decision | 1 | 0 |
| Death | 1 | 0 |
| PD | 10 | 0 |
| Continuing Maintenance | 9 | 0 |
Long-Term Follow-Up (Up to 2 Years)
| Stage | R-CHOP and Enzastaurin | R-CHOP |
|---|---|---|
| STARTED | 6 | 26 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 6 | 26 |
Reasons for not completing this period:
| Reason | R-CHOP and Enzastaurin | R-CHOP |
|---|---|---|
| Continuing Follow-Up | 6 | 26 |
Analysis population for the primary outcome, as defined in the registry: Randomized participants who received at least 1 dose of enzastaurin or any drug in the R-CHOP regimen who had at least 1 post-baseline efficacy measurement. A total of 34 and 21 participants were censored in the R-CHOP/Enzastaurin and R-CHOP arms, respectively.
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: Randomized participants who received at least 1 dose of enzastaurin or any drug in the R-CHOP regimen.
| Characteristic | Unit | R-CHOP and Enzastaurin | R-CHOP | Total |
|---|---|---|---|---|
| Participants analysed | 57 | 43 | 100 | |
| Age, Continuous | years | 63.5 (SD 13.55) | 63.3 (SD 12.36) | 63.4 (SD 12.99) |
| Sex: Female, Male: Female | Participants | 23 | 21 | 44 |
| Sex: Female, Male: Male | Participants | 34 | 22 | 56 |
| Race/Ethnicity, Customized: Caucasian | Participants | 46 | 39 | 85 |
| Race/Ethnicity, Customized: African | Participants | 6 | 3 | 9 |
| Race/Ethnicity, Customized: Hispanic | Participants | 3 | 1 | 4 |
| Race/Ethnicity, Customized: East Asian | Participants | 2 | 0 | 2 |
| Race/Ethnicity, Customized: West Asian | Participants | 0 | 0 | 0 |
| Region of Enrollment: United States | Participants | 57 | 43 | 100 |
| International Prognostic Index (IPI) | units on a scale | 2.88 (SD 0.803) | 2.84 (SD 0.843) | 2.86 (SD 0.815) |
6. Primary Endpoint
The registry lists the primary outcome as Progression-Free Survival (PFS) Time, measured over Randomization to measured PD or death from any cause (up to 55 months).
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | 95% Confidence Interval |
| Unit | months |
| Endpoint classification | Time-to-Event Analysis |
Progression-free survival time is the elapsed time from randomization to the first objectively determined progression of disease or death from any cause. The registry describes progression as assessed according to International Working Group recommendations (Cheson et al. 1999), including enlarging liver or spleen nodules, new or increased lymph nodes or masses, and reappearance of bone marrow infiltrate.
This endpoint is used to capture both how long participants remain alive without documented progression and events that preclude continued progression-free follow-up. Unlike a simple response proportion at one visit, a time-to-event outcome can incorporate the timing of events and can retain information from participants whose event status is not yet known at the cutoff through censoring. Censoring does not mean that an event occurred; it means that the event time was not observed during the available follow-up under the stated analysis rules.
For participants not known to have died and without objective progression at the data cutoff, the record says PFS was censored at the last objective progression-free disease assessment. If subsequent anticancer therapy other than enzastaurin maintenance began before progression or death, PFS was censored at the last objective progression-free assessment before that therapy. Those rules matter because the estimated event-time distribution depends on how incomplete follow-up and treatment changes are handled.
The registry reports the median PFS for each group, with a 95% confidence interval. A median describes the time by which half the estimated event-time distribution has experienced an event; it is not an average duration for every participant. The upper confidence limits are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry reports a median PFS of 36.2 months for R-CHOP plus enzastaurin, with a 95% confidence interval lower limit of 20.2 months and no upper limit reported. For R-CHOP, the median is 22.6 months, with a 95% confidence interval lower limit of 8.9 months and no upper limit reported. These are group-level time-to-event estimates, not a direct numerical estimate of the treatment contrast. The registry record does not report a sponsor-reported hazard ratio or its confidence interval, so the relative event rate over follow-up cannot be read from the posted primary results.
A confidence interval describes statistical uncertainty around an estimate under the analysis assumptions. The reported lower limits indicate that the intervals extend below the respective medians; because the upper limits are not reported, the full interval widths cannot be assessed. The medians alone do not show how the event experience differed over the whole follow-up period, and they do not provide the precision of a between-group comparison.
Participants were censored under the registry’s stated rules when follow-up ended without a recorded event, or when subsequent anticancer therapy began before progression or death. The record reports 34 censored participants in the R-CHOP/enzastaurin group and 21 in the R-CHOP group for the primary outcome. Censoring can be informative if the reasons for loss of observed follow-up are related to the risk of an event; the registry summary does not provide enough information to evaluate that possibility.
The posted primary estimates should therefore be read descriptively. They show the reported medians and partial confidence-interval information for the analysis population, not proof that one regimen causes a longer or shorter PFS. Randomization supports a comparative design, but interpretation also depends on the analysis population, censoring, follow-up, and complete reporting of the comparative analysis. The registry record does not report the sponsor’s hazard-ratio result, a primary comparison p-value, or the full upper confidence limits. Those absent quantities prevent a complete assessment of the comparative estimate and its precision from this record alone.
Selected secondary results give additional outcome descriptions, but they do not replace the primary time-to-event comparison. The registry’s 2-year PFS and PET-negative rates have confidence intervals, and simple unadjusted calculations from posted counts are available for those outcomes. Such calculations are not the sponsor’s reported analyses. They are exploratory summaries and should not be given the same weight as a prespecified, fully reported primary analysis.
9. Statistical Methods Explained
Progression-free survival is a time-to-event outcome. In general, time-to-event methods account for both whether an event was observed and how long each participant was followed. Participants whose event status remains unknown at the end of observation can contribute information up to their censoring time. The registry’s rules define the event as objectively determined progression or death from any cause and specify how follow-up is censored in the absence of an observed event.
What does the median describe?
In general, the median event time is the point at which the estimated event-time distribution reaches the halfway mark. It is distinct from a mean, which averages event times, and from a fixed-time event percentage. A median is a compact summary, but it does not describe the full shape of the event curve or the timing of all events. Two groups can have different medians while their event patterns vary at other follow-up times.
The registry reports median PFS of 36.2 months for R-CHOP plus enzastaurin and 22.6 months for R-CHOP. It gives lower confidence limits of 20.2 months and 8.9 months, respectively, but the upper limits are not reported in the registry record. The record also does not report sponsor-reported hazard ratios. In general, a hazard ratio summarizes a relative event rate over follow-up under a time-to-event model; it is not the same as a ratio of medians and cannot be reconstructed from the posted medians alone.
What does censoring mean?
In general, a censored observation means that the event was not observed by the participant’s last usable follow-up time. It is not equivalent to an event-free outcome for all later time. The registry says participants without known death or objective progression at cutoff were censored at their last objective progression-free disease assessment. It also specifies censoring before subsequent anticancer therapy, other than enzastaurin maintenance, when that therapy began before progression or death.
Time-to-event estimates rely on assumptions about censoring. In general, estimates can be biased if participants who are censored differ in their future event risk in ways not addressed by the analysis. The record gives censoring counts for the primary outcome, but it does not report the reasons behind those counts or an evaluation of whether the censoring process could affect the estimates.
How should confidence intervals be read?
In general, a 95% confidence interval represents uncertainty in an estimate under the statistical method and its assumptions. It is not a range that guarantees the true value lies within it, and it is not an interval for individual participant outcomes. The primary results include only the lower limits, so the complete uncertainty intervals cannot be reviewed. The registry record does not report the sponsor’s comparative hazard ratio and confidence interval, which would be important for interpreting the relative time-to-event result.
The secondary binary outcomes use confidence intervals around percentages. A percentage at a fixed assessment time answers a different question from median PFS. The 2-year PFS rate describes the estimated fraction alive and progression-free at that time, while the PET-negative rate describes scan status at Cycle 6. Neither is interchangeable with the full time-to-event endpoint.
What do the recalculations add?
Unadjusted recalculations from posted summary counts can express a simple difference between two group proportions. They do not account for covariates, time-to-event follow-up, or any analysis features not contained in those counts. For the listed secondary comparisons, recalculated p-values are 0.379 for 2-year PFS and 0.726 for PET-negative status. These are unadjusted recalculations, not reported sponsor analyses. The registry record lists no reported analyses for those secondary outcomes, so the recalculations should not be treated as a substitute for the sponsor’s analysis.
General statistical interpretation also distinguishes a p-value from the size and precision of an effect. A p-value does not measure clinical importance, and a result that does not cross a conventional threshold does not demonstrate equality. Confidence intervals and the design of the analysis are needed to understand which effects remain compatible with the data.
How should planning illustrations be understood?
The sample-size illustrations use the observed effect as a planning reference, with scenarios for detecting 100%, 75%, or 50% of that effect. The stated assumptions are a two-sided significance level of 0.05, equal allocation, and a normal approximation. These are planning illustrations, not the study’s observed power or the trial’s original design justification. In general, planning estimates depend on the assumed effect and statistical model; smaller target effects usually require more participants to detect with a specified power. The registry record does not report a sample-size justification for this trial.
10. Multiplicity, Missing Data and Analysis Populations
The record names multiple secondary outcomes, including response measures, fixed-time PFS, PET findings, event-free survival, overall survival, duration of complete response, and safety. It does not report a multiplicity-adjustment plan or explain whether particular secondary analyses were intended to be confirmatory or exploratory. In general, testing multiple outcomes without adjustment makes isolated small p-values less persuasive because more comparisons create more opportunities for chance findings. The posted unadjusted recalculations should therefore be interpreted cautiously.
Missingness and censoring are also relevant. For the primary endpoint, the record specifies censoring rules and reports 34 censored participants in the R-CHOP/enzastaurin group and 21 in the R-CHOP group. It does not describe the reasons for censoring in detail or provide an assessment of whether censoring may be related to prognosis. The amount and handling of missing data for the secondary outcomes are not reported in the registry record.
The primary analysis population consisted of randomized participants who received at least one dose of enzastaurin or any drug in the R-CHOP regimen and had at least one post-baseline efficacy measurement. This is a treated, evaluable population rather than an explicitly stated all-randomized intention-to-treat population. The registry record does not report a separate intention-to-treat analysis or sensitivity analyses using alternative populations or censoring assumptions.
Safety outcomes use at-risk counts of 57 and 43, while the primary efficacy results list analysis counts of 56.0 and 42.0. These are outcome-specific populations and should not be assumed to be interchangeable. The record does not report a detailed explanation of differences between analysis denominators. It also does not report an interim-analysis plan, missing-data imputation methods, or subgroup-analysis methods. These gaps limit assessment of robustness and of how selective reporting or incomplete follow-up might affect interpretation.
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 |
|---|---|---|---|
| R-CHOP and Enzastaurin | 35 | 57 | 61.4% |
| R-CHOP | 18 | 43 | 41.9% |
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 |
|---|---|
| R-CHOP and Enzastaurin | 56 of 57 |
| R-CHOP | 43 of 43 |
Most frequent serious adverse event terms
| Event term | Organ system | R-CHOP and Enzastaurin | R-CHOP |
|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | 9 of 57 | 3 of 43 |
| Pyrexia | General disorders | 3 of 57 | 4 of 43 |
| Pneumonia | Infections and infestations | 5 of 57 | 2 of 43 |
| Sepsis | Infections and infestations | 2 of 57 | 4 of 43 |
| Anaemia | Blood and lymphatic system disorders | 4 of 57 | 1 of 43 |
| Neutropenia | Blood and lymphatic system disorders | 2 of 57 | 3 of 43 |
| Urinary tract infection | Infections and infestations | 2 of 57 | 2 of 43 |
| Thrombocytopenia | Blood and lymphatic system disorders | 1 of 57 | 2 of 43 |
| Atrial fibrillation | Cardiac disorders | 1 of 57 | 2 of 43 |
| Bacteraemia | Infections and infestations | 2 of 57 | 1 of 43 |
Most frequent non-serious adverse event terms
| Event term | Organ system | R-CHOP and Enzastaurin | R-CHOP |
|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | 33 of 57 | 26 of 43 |
| Fatigue | General disorders | 30 of 57 | 29 of 43 |
| Nausea | Gastrointestinal disorders | 29 of 57 | 19 of 43 |
| Alopecia | Skin and subcutaneous tissue disorders | 26 of 57 | 17 of 43 |
| Diarrhoea | Gastrointestinal disorders | 27 of 57 | 15 of 43 |
| Constipation | Gastrointestinal disorders | 22 of 57 | 18 of 43 |
| Anaemia | Blood and lymphatic system disorders | 22 of 57 | 14 of 43 |
| Thrombocytopenia | Blood and lymphatic system disorders | 16 of 57 | 18 of 43 |
| Leukopenia | Blood and lymphatic system disorders | 16 of 57 | 14 of 43 |
| Stomatitis | Gastrointestinal disorders | 19 of 57 | 10 of 43 |
Serious events with the highest arm-level rate: febrile neutropenia (15.8%), pyrexia (9.3%), sepsis (9.3%), pneumonia (8.8%), anaemia (7.0%).
The registry reports serious adverse event counts among 57 participants at risk in the R-CHOP/enzastaurin group and 43 at risk in the R-CHOP group. Serious adverse events affected 35 participants and 18 participants, respectively. Other treatment-emergent adverse events affected 56 of 57 participants in the R-CHOP/enzastaurin group and 43 of 43 in the R-CHOP group. These counts describe the posted safety populations; they are not the primary efficacy-analysis populations.
The most frequently listed serious adverse event terms include febrile neutropenia (15.8%), pyrexia (9.3%), sepsis (9.3%), pneumonia (8.8%), anaemia (7.0%), and neutropenia (7.0%). These term-specific percentages should be read as registry-reported safety summaries, not as a complete profile of all event severity, duration, or clinical course. The registry record does not report the number of deaths in the safety summary.
In general, adverse-event counts do not by themselves establish whether a treatment caused an event. Comparisons can be affected by exposure duration, ascertainment, event definitions, and the size and composition of the safety population. The posted counts offer descriptive context; the registry entry does not provide enough detail to make a comprehensive comparative safety assessment.
12. What the Result Does, and Does Not, Mean
The primary result means that the registry reports different group medians for progression-free survival in the analysis population: 36.2 months for R-CHOP plus enzastaurin and 22.6 months for R-CHOP. The reported confidence intervals include lower limits of 20.2 months and 8.9 months, while their upper limits are not reported. These figures describe the posted estimates; they do not, by themselves, quantify the relative event rate or establish the precision of the difference between groups.
The record does not report the sponsor’s hazard ratio, its confidence interval, or a primary comparison p-value. The posted medians therefore should not be treated as a complete comparative analysis. They also do not show what would have happened to the same participants under the alternative regimen. Randomization provides a comparative design, but the registry summary is not sufficient to resolve all questions about analysis populations, censoring, and uncertainty.
The result does not mean that every participant had the reported median time, nor does the median describe an individual’s expected course. A median is a group summary of an estimated event-time distribution. Censoring means that event-free status was not observed indefinitely for some participants; it does not mean that those participants remained free of progression after their last assessment.
The secondary outcomes and safety summaries add context but cannot fill gaps in the primary comparison. Some named secondary outcomes do not have results reported in the registry record, and the available secondary calculations are unadjusted. Safety counts are descriptive and use their own at-risk denominators. Together, the posted data support a careful description of reported outcomes, not a definitive claim about treatment effect, clinical benefit, or safety.
In general, treatment decisions require clinical context and a full evaluation of the evidence. The registry record is a summary of trial information, and its incomplete reporting of comparative time-to-event statistics and several secondary results limits the conclusions that can be drawn from this entry alone.
13. Why This Trial Matters Statistically
This trial illustrates why a time-to-event outcome cannot be interpreted from a pair of medians alone. Median PFS gives a concise summary for each group, but a comparative assessment also depends on the full event-time analysis, uncertainty around the contrast, and handling of censoring. In this record, the full upper confidence limits and sponsor-reported hazard ratio are not reported, leaving key elements of the primary comparison unavailable.
It also shows why analysis populations need to be read outcome by outcome. The primary endpoint uses participants who received treatment and had a post-baseline efficacy measurement, while safety counts use different at-risk numbers. Assuming those denominators represent the same population could lead to incorrect interpretation. The record’s censoring counts and rules likewise demonstrate that follow-up status is part of the endpoint definition, not a minor technical detail.
The secondary outcomes illustrate the distinction between event-time outcomes and fixed-time or scan-based measures. Such outcomes may offer complementary information, but multiple unadjusted comparisons can make isolated patterns less compelling. Without a reported multiplicity plan and complete secondary results, consistency across outcomes cannot be fully assessed.
Finally, the planning illustrations are not observed power and do not explain the original trial design. They depend on stated assumptions and on the observed effect used as a reference. The registry record does not report the study’s sample-size justification. These features make the trial useful for understanding the importance of complete reporting: estimates, uncertainty, population definitions, censoring, multiplicity, and planning assumptions all shape what a reader can reasonably infer.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The primary comparative evidence in the registry record is incomplete. It reports group medians and lower confidence limits, but not upper confidence limits, a sponsor-reported hazard ratio, or a primary comparison p-value. As a result, the precision and relative time-to-event contrast cannot be fully evaluated from the posted primary results.
The primary efficacy population was restricted to participants who received at least one dose and had at least one post-baseline efficacy measurement. The record does not report a separate intention-to-treat analysis or sensitivity analyses. It also does not provide detailed reasons for censoring or an assessment of whether censoring may be informative. These omissions make it difficult to judge how robust the PFS estimates are to analysis-population and follow-up choices.
The study was open-label, and the registry does not report masking of outcome assessment. The record describes objective progression criteria and an assessment framework, but does not provide enough information to assess how consistently assessments were conducted or whether knowledge of treatment assignment could have affected measurement or follow-up.
Several named secondary outcomes have no results reported in the registry record, and the record does not describe a multiplicity plan. The safety summary is also limited: it gives adverse-event counts and selected serious-event terms, but the number of deaths is not reported, and further detail on exposure, severity, and event duration is not included in the registry entries. The registry record does not report a sample-size justification, interim-analysis plan, randomization ratio, or allocation-concealment procedure. These gaps constrain assessment of design choices and of the completeness of the reported evidence.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study of Participants With Lymphoma Who Take R-CHOP and Enzastaurin Compared to Participants Who Take R-CHOP Only — NCT00451178.
- Registry record last updated 2020-07-21; status last verified 2020-07.
- Results first posted 2020-07-21.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry describes NCT00451178 as a completed, randomized, open-label, parallel-group phase 2 study comparing R-CHOP plus enzastaurin with R-CHOP alone for first-line treatment of intermediate- and high-risk diffuse large B-cell lymphoma. The primary outcome was PFS time from randomization to objectively determined progression or death from any cause.
The reported median PFS was 36.2 months in the R-CHOP/enzastaurin group and 22.6 months in the R-CHOP group. The record gives lower confidence limits but not upper limits, and it does not report a sponsor hazard ratio for the primary comparison. Selected secondary outcomes and safety counts are posted, but the registry record does not report results for all named secondary outcomes or a multiplicity plan. These reporting limits should inform interpretation of the trial summary.