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 Doxorubicin (Doxil) Combined With Rituxan, Cyclophosphamide, Vincristine and Prednisone in Newly Diagnosed Aggressive Non-Hodgkin's Lymphomas (NCT00184002), a na phase 2 study. The primary outcome is Percentage of Patients With Complete Response to the Combination Chemotherapy.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00184002 |
| Phase | Phase 2 |
| Condition | Non-Hodgkin's Lymphoma |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 68 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Southern California |
| Results posted | Yes |
2. Clinical Question
Population
People with newly diagnosed aggressive non-Hodgkin's lymphomas were the intended population. The condition is recorded as Non-Hodgkin's Lymphoma. The registry record does not give further eligibility details or describe the characteristics of the enrolled participants, so the specific lymphoma subtypes and the enrolled population's baseline profile are not reported in the registry record.
Intervention
The study evaluated a combination of pegylated liposomal doxorubicin, also called Doxil, rituximab, cyclophosphamide, vincristine and prednisone. The regimen is referred to as DR-COP. The registry describes replacing conventional doxorubicin in the R-CHOP regimen with Doxil as the rationale for the study. The detailed treatment schedule after cycle 1 is not reported in the registry record.
Comparator
There was no concurrent comparison group: the study model is single group, allocation is recorded as not applicable, and masking is recorded as none. The study therefore does not provide a randomized, like-for-like comparison between DR-COP and another regimen. Background statements about R-CHOP in the registry summary are context for the question, not results from a control arm in this study.
Primary question
The primary question was what percentage of participants had a complete response to the combination chemotherapy at completion of cycle 4, cycle 6 and cycle 8. Initial response tests were planned after cycle 4 for all patients. Later assessments depended on response: treatment could continue for a documented complete or partial response, while stable or progressive disease led to withdrawal from the study. The numerical complete-response result is not reported in the registry record.
In statistical terms, this is a descriptive question about response in a treated group. The regimen was studied in newly diagnosed aggressive non-Hodgkin's lymphomas, with tumor response determined according to criteria attributed in the registry description to an international workshop on response criteria for non-Hodgkin's lymphomas. The central interpretive limit is that there is no concurrent control group. A response proportion, even if reported, would describe outcomes among participants treated in this study; it would not by itself estimate the difference between DR-COP and another regimen or establish that any observed response was caused by the regimen.
3. Trial Design
NCT00184002 is recorded as a completed phase II study sponsored by the University of Southern California. It enrolled 68 participants and used a single-group model. Allocation is listed as not applicable, and masking as none. These design features mean the registry record describes a treated group rather than randomized assignment to competing treatments. There is no like-for-like control arm in the record, so comparative effects cannot be estimated directly from this study.
The intervention was the combination of Doxil, rituximab, cyclophosphamide, vincristine and prednisone, called DR-COP in the arm description. The registry summary presents the substitution of liposomal doxorubicin for doxorubicin in R-CHOP as the study's rationale. The arm description specifies treatment for cycle 1 and begins to describe treatment in later cycles, but the complete later-cycle schedule is not reported in the registry record. The primary endpoint was the percentage of participants with complete response, assessed at completion of cycles 4, 6 and 8. Assessment after cycle 4 was planned for all participants; later assessment and continuation depended on response.
The registry records the study start as 2003-01-10, primary completion as 2012-12-19, and status as completed. These dates describe the trial record, not the timing or availability of a particular analysis. Although the record gives enrollment and endpoint definitions, a protocol-level description of the statistical plan, the primary analysis population, the method for calculating uncertainty, and the handling of missing response assessments is not reported in the registry record. The record lists no analyses. Accordingly, the design and endpoint can be described, but the inferential procedures and a numerical estimate of the primary response cannot be reconstructed from the registry information.
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: There were no pre-assignment criteria. All subjects were given the same treatment.
Overall Study
| Stage | DR-COP |
|---|---|
| STARTED | 68 |
| COMPLETED | 51 |
| NOT COMPLETED | 17 |
Reasons for not completing this period:
| Reason | DR-COP |
|---|---|
| Adverse Event | 9 |
| Death | 3 |
| Physician Decision | 1 |
| Withdrawal by Subject | 4 |
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 | DR-COP |
|---|---|---|
| Participants analysed | 68 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 60 |
| Age, Categorical: >=65 years | Participants | 8 |
| Sex: Female, Male: Female | Participants | 39 |
| Sex: Female, Male: Male | Participants | 29 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 48 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 20 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 12 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 1 |
| Race (NIH/OMB): Black or African American | Participants | 0 |
| Race (NIH/OMB): White | Participants | 7 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 48 |
| Region of Enrollment: United States | participants | 68 |
6. Primary Endpoint
The registry lists the primary outcome as Percentage of Patients With Complete Response to the Combination Chemotherapy, measured over At completion of cycle 4, 6, and 8.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Percentage of participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the percentage of participants with a complete response to the combination chemotherapy. It is assessed at completion of cycle 4, cycle 6 and cycle 8. In practical terms, the outcome classifies response as complete response or not complete response at the specified assessment. The registry says response was to be determined using criteria proposed in an international workshop report on response criteria for non-Hodgkin's lymphomas.
A complete-response proportion is a binary-outcome summary: each assessed participant contributes a response classification, and the proportion describes how common complete response was in the group being summarized. This kind of endpoint is used to describe tumor response rather than the time until an event. It can be clinically interpretable as a frequency, but its meaning depends on the response definition, the assessment schedule, the participants included in the denominator, and how unavailable or unevaluable assessments are handled. Those analysis details are not reported in the registry record.
The assessment plan also makes the time point important. Initial response testing was planned after cycle 4 for all patients. Subsequent evaluation after cycle 6 and/or cycle 8 depended on prior response, and stable or progressive disease after cycle 4 led to withdrawal from the study. Thus later response summaries, if calculated only among those continuing treatment, would not necessarily describe the original enrolled group without an explicitly defined analysis approach. The numerical endpoint results and their uncertainty are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies complete response as the primary outcome, but does not report a numerical complete-response percentage, a participant count with complete response, or an uncertainty interval. It also lists no analyses. As a result, the posted results do not allow readers to quantify the observed response, assess its precision, or evaluate a statistical test for the primary endpoint. The endpoint definition and planned assessment times are available; the primary result is not reported in the registry record.
The study's single-group design sets an important boundary on interpretation. An outcome among participants receiving DR-COP could describe what happened in that treated group, but it would not estimate what would have happened to comparable participants receiving another regimen. The registry's background discussion of R-CHOP does not serve as a concurrent control group. Differences between outcomes in this cohort and outcomes from other settings could reflect participant selection, disease mix, assessment practices, follow-up, or other factors, not only treatment. The record does not provide a comparative estimate.
Precision is also not assessable for the primary endpoint. In general, a confidence interval expresses the range of values reasonably compatible with the observed data under the interval's statistical assumptions. A narrow interval would indicate greater precision than a wide interval, while neither interval alone resolves design limitations or establishes causation. No primary response interval or method for calculating one is reported in the registry record. The enrollment of 68 does not replace an endpoint estimate or its uncertainty; the number with an evaluable response and the denominator used at each assessment are not reported.
Safety information is more numerically detailed. In the DR-COP group, 35 of 68 participants are recorded as having serious adverse events, and 27 of 68 are recorded in the other adverse-event count; 3 deaths are also listed. These are registry counts, not comparative estimates. The record does not establish from these figures whether an event was caused by treatment, how event categories overlap, or the timing and duration of observation. The serious-event terms are listed with percentages, but the registry information does not clarify whether each percentage represents participants, events, or another denominator. They should therefore be read as recorded term percentages rather than treated as a basis for an unreported comparative risk analysis.
Overall, the record documents a phase II treatment study, its response question, and safety counts. It does not provide the primary response result, formal inferential analysis, or a concurrent comparison. Statistical interpretation should remain descriptive and bounded by those absences. In particular, the registry entry cannot support a claim that DR-COP is more or less effective or safer than another regimen.
9. Statistical Methods Explained
What does a single-group design estimate?
General statistical explanation: a single-group study observes outcomes among participants receiving a study intervention. For a binary response endpoint, a natural descriptive summary is the proportion classified as having the specified response among a defined analysis group. That estimate describes the observed group and depends on which participants are counted and how response is classified. Without a concurrent control group, it does not directly estimate a treatment contrast. In this trial, the registry records a single-group model and no allocation to a comparison arm. A comparative effect of DR-COP versus another regimen is therefore not available from the design described.
The registry's primary endpoint is a complete-response percentage at completion of cycles 4, 6 and 8. Although this wording identifies the type of outcome and planned assessment times, it does not give the response count, denominator, or estimate at any assessment. A numerical proportion cannot be reconstructed without those values, and no such calculation should be inferred from enrollment alone. The registry record lists no analyses.
How should binary response be summarized?
General statistical explanation: binary outcomes classify each observation into one of two categories for a particular analysis, such as complete response versus no complete response. A proportion is meaningful only when its denominator is clear. Analysts may also report uncertainty around the proportion, commonly with a confidence interval. The interval communicates sampling uncertainty under its statistical assumptions; it does not correct for selection bias, outcome misclassification, missing data, or lack of a comparator.
For this endpoint, interpretation would require knowing whether the denominator includes all enrolled participants, only those assessed, or another prespecified population. It would also require knowing how participants who withdrew, died, missed an assessment, or had an unevaluable assessment were classified. These details are not reported in the registry record. No confidence interval, test, or estimation method for the primary response is reported either. Consequently, the endpoint's statistical precision and the sensitivity of its estimate to analysis choices cannot be assessed.
Why do assessment times and response-dependent continuation matter?
General statistical explanation: repeated assessment times can yield different summaries because response may change over time and because the participants assessed at later times may differ from the original group. In this study, assessment after cycle 4 was planned for all patients. Continued treatment and later assessment depended on the response after cycle 4; patients with stable or progressive disease were to be withdrawn. If later outcomes were summarized only among those who continued, that summary would describe a selected subset, not automatically the full enrolled cohort. This does not make the later assessments unusable, but it makes the denominator and analysis definition essential to interpretation.
The registry names completion of cycle 4, 6 and 8 as the endpoint timeframe but does not report separate response counts or analysis populations for those times. It is therefore not possible to determine whether the endpoint was intended as separate time-specific proportions, a particular assessment rule, or another summary across the visits. The analysis plan is not reported in the registry record.
What can a confidence interval or test add?
General statistical explanation: an estimate gives a point summary, while an interval conveys uncertainty around it under a stated model. A hypothesis test, when used, evaluates compatibility of data with a specified null hypothesis under the test's assumptions. Neither a confidence interval nor a p-value is a measure of clinical importance by itself. Their interpretation requires the outcome estimate, the analysis population, the statistical method, and the design context.
No primary response estimate, confidence interval, or p-value is reported in the registry record. No hypothesis, significance threshold, or statistical method for the primary endpoint is reported. Without these, readers cannot assess statistical evidence from the primary outcome or compare an estimate with a prespecified target. The absence of these details should not be filled by assuming a conventional method or a particular protocol.
What do the sample-size illustrations mean?
General statistical explanation: planning sample sizes are prospective illustrations of how many participants might be needed under specified assumptions; they are not observed outcomes and are not a measure of the evidence produced by the completed trial. The registry's stated illustration assumptions use a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of an observed effect. These are planning conventions, not evidence that this single-group trial randomized participants between two arms. The trial itself is recorded as single group, with allocation not applicable.
The record describes the sample-size material as planning based on an observed effect, but the primary response result and any analysis producing that effect are not reported in the registry record. The illustration assumptions therefore cannot be treated as the trial's own design justification or as observed power. The protocol's sample-size justification is not reported in the registry record. The assumptions do not demonstrate that the completed enrollment was sufficient for a particular precision or decision, and no sample-size calculation can substitute for the missing primary result.
Why does over-dispersion matter in general?
General statistical explanation: over-dispersion occurs when the variability in data is greater than a statistical model assumes. If a model understates variability, standard errors can be too small and confidence intervals too narrow; significance tests may then appear more decisive than warranted. The issue is relevant to some count or clustered outcomes, but the primary outcome recorded in this trial is a binary response percentage. The registry does not report a model-based primary analysis, a dispersion assessment, or a method that would make over-dispersion a specific documented issue in this study. It would not be appropriate to claim that the trial used or needed a correction for it.
More broadly, statistical methods are not reported in enough detail to reproduce or audit the primary analysis. The registry specifies the clinical outcome and assessment schedule, but not the estimator, uncertainty method, missing-data strategy, or analysis population. Those omissions limit evaluation of precision and robustness; they do not authorize assumptions about what the protocol may have specified.
10. Multiplicity, Missing Data and Analysis Populations
The primary endpoint has planned assessments at completion of cycle 4, cycle 6 and cycle 8. Looking at an outcome at multiple assessment times can raise a multiplicity question if several results are tested or if the most favorable time point is selected for emphasis. General statistical explanation: multiplicity refers to the increased chance of a misleading positive finding when multiple hypotheses or outcomes are examined without an appropriate plan for interpretation or adjustment. Whether adjustment is needed depends on the prespecified objectives and analysis strategy, not merely on the existence of more than one assessment.
The registry record does not report whether the assessments were treated as separate primary comparisons, how they were ordered, or whether any multiplicity procedure was planned. It also does not report interim analyses. The statistical plan is not reported in the registry record, so it is not possible to determine how multiplicity was addressed or whether it was relevant under the intended analysis.
Missing response data are another unresolved issue. The record does not describe how missed visits, withdrawals, deaths, or unevaluable assessments were handled in the primary analysis. This matters because assessment after cycle 4 was planned for all patients, while later treatment and assessment depended on response; participants with stable or progressive disease after cycle 4 were to be withdrawn. The denominator at each time point and the analysis population are not reported in the registry record.
The record also does not specify whether the primary analysis was intended to include all enrolled participants, all treated participants, or only those with an assessable response. No imputation strategy, sensitivity analysis, or rule for classifying missing outcomes is reported. These omissions mean the effect of missingness on the response estimate cannot be evaluated. Neither a particular missing-data method nor an adjustment for multiple assessments should be inferred from the endpoint description alone.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| DR-COP | 35 | 68 | 51.5% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| DR-COP | 3 of 68 |
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 |
|---|---|
| DR-COP | 27 of 68 |
Most frequent serious adverse event terms
| Event term | Organ system | DR-COP |
|---|---|---|
| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | 35 of 68 |
| Hemoglobin | Blood and lymphatic system disorders | 11 of 68 |
| Hand-foot skin reaction | Skin and subcutaneous tissue disorders | 10 of 68 |
| Febrile neutropenia | Infections and infestations | 8 of 68 |
| Infection | Infections and infestations | 8 of 68 |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | 6 of 68 |
| Infection without neutropenia | Infections and infestations | 6 of 68 |
| Platelets | Blood and lymphatic system disorders | 5 of 68 |
| Hypokalemia | Metabolism and nutrition disorders | 3 of 68 |
| SGOT (AST) (serum glutamic oxaloacetic transaminase) | Hepatobiliary disorders | 3 of 68 |
Most frequent non-serious adverse event terms
| Event term | Organ system | DR-COP |
|---|---|---|
| Pain | General disorders | 27 of 68 |
| Alopecia | Skin and subcutaneous tissue disorders | 24 of 68 |
| Hemoglobin | Blood and lymphatic system disorders | 23 of 68 |
| Fatigue (lethargy, malaise, asthenia) | General disorders | 22 of 68 |
| Nausea | Gastrointestinal disorders | 22 of 68 |
| Constipation | Gastrointestinal disorders | 19 of 68 |
| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | 19 of 68 |
| Hand-foot skin reaction | Skin and subcutaneous tissue disorders | 18 of 68 |
| Stomatitis/pharyngitis (oral/pharyngeal mucositis) | Gastrointestinal disorders | 17 of 68 |
| Anorexia | Metabolism and nutrition disorders | 16 of 68 |
Serious events with the highest arm-level rate: neutrophils/granulocytes (anc/agc) (51.5%), hemoglobin (16.2%), hand-foot skin reaction (14.7%), febrile neutropenia (11.8%), infection (11.8%).
The DR-COP safety record lists 35 participants with serious adverse events among 68 at risk, 27 with other adverse events among 68 at risk, and 3 deaths. These are reported counts for the study group. They do not, by themselves, show whether an event was caused by treatment or whether the deaths were related to treatment. The record does not provide a concurrent control group, so these counts are not comparative estimates of safety.
The registry also lists serious adverse-event terms with percentages: neutrophils/granulocytes (ANC/AGC), 51.5%; hemoglobin, 16.2%; hand-foot skin reaction, 14.7%; febrile neutropenia, 11.8%; infection, 11.8%; and dyspnea (shortness of breath), 8.8%. The denominator and counting unit for these term percentages are not clarified in the registry record. They should not be assumed to represent the percentage of participants affected unless the underlying definition confirms that interpretation. Terms may also overlap within a participant, and the record does not describe how such overlap was handled.
General statistical explanation: adverse-event summaries depend on the event definition, time at risk, follow-up completeness, and whether counts refer to people or event episodes. The registry record does not report these details sufficiently to support a rate comparison or causal interpretation. The listed counts and terms are descriptive safety information, not proof of benefit or harm relative to another treatment.
12. What the Result Does, and Does Not, Mean
The record establishes that a phase II, single-group study of DR-COP was completed and enrolled 68 participants. It defines complete response as the primary outcome and specifies response assessment at completion of cycles 4, 6 and 8. It also records serious and other adverse-event counts and lists serious-event terms with percentages. These registry entries describe the study question and some safety reporting.
The primary response result itself is not reported in the registry record. There is no complete-response count or percentage, no uncertainty interval, and no listed analysis. Consequently, the posted information cannot establish the observed response frequency, how precisely it was estimated, or how results varied across the planned assessment times. The missing numerical result cannot be inferred from the trial's enrollment, treatment rationale, or safety counts.
Even if a response proportion were available, the single-group design would limit what it could show. It could describe the outcome among the participants analyzed, but without a concurrent control group it would not establish how those same participants would have fared under another regimen. It would not isolate a treatment effect from participant selection, disease characteristics, care context, or other influences. The background discussion of R-CHOP does not supply a randomized comparison.
Likewise, safety counts provide a description of recorded events, not a comparison of safety between treatments. The registry does not establish event attribution, specify all relevant denominators, or report a control group. Neither the response question nor the safety summaries support a claim that DR-COP works or does not work, or that it is safer or less safe than another regimen. They show what the study was designed to assess and what safety counts were recorded; the primary outcome estimate and comparative evidence are not reported in the registry record.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of the difference between a clearly stated clinical question and a fully interpretable result. The registry defines a response endpoint, gives planned assessment times, and records enrollment in a phase II, single-group study. Yet the primary numerical response result and the analysis are not reported in the registry record. Without the estimate and its uncertainty, readers cannot judge the magnitude or precision of the response outcome from the posted information.
The design also illustrates the boundary between descriptive and comparative evidence. A single-group study can document outcomes among treated participants, but it cannot create a concurrent counterfactual comparison. Historical context may explain why a regimen was studied, but it is not equivalent to random allocation. This distinction matters whenever a treatment question is phrased comparatively while the study itself has no control arm.
The response-dependent assessment plan adds a further statistical issue: later assessments may concern a selected group of participants who continued after earlier response evaluation. Clear denominators and analysis-population rules are needed to interpret such summaries. The registry does not report those rules, which illustrates why endpoint labels alone do not fully define an analysis.
Finally, the safety record shows why event counts and percentages need explicit definitions. Participant counts, event counts, denominators, follow-up periods, and causal attribution answer different questions. The registry lists useful safety information, but the absent details constrain interpretation. Overall, the study record demonstrates that statistical transparency requires more than an endpoint name and an enrollment total: analysis methods, denominators, missing-data handling, and results are central to evaluating what the evidence can support.
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 trial-specific limitation is the absence of a concurrent comparison group. The single-group design cannot estimate a direct difference between DR-COP and another regimen. The registry's contextual discussion of R-CHOP is not a control arm, and the record does not support a randomized comparison.
The primary complete-response result is not reported in the registry record. No numerical response estimate, response count, confidence interval, or primary analysis is listed. The record also does not report the analysis population or the denominator used at each planned assessment. These omissions prevent evaluation of the response's magnitude, precision, and consistency across cycles.
The assessment schedule creates a specific interpretive concern: all patients were to have initial testing after cycle 4, but later assessment depended on prior response, and stable or progressive disease led to withdrawal. The registry does not explain how withdrawals, missed or unevaluable assessments, or other missing response data were handled. It is therefore unclear how later response summaries, if any, relate to the enrolled group.
The statistical plan is not reported in the registry record. Methods for estimation, uncertainty, hypothesis testing, multiplicity, and sensitivity analysis cannot be assessed, and interim analyses are not reported. The complete treatment schedule after cycle 1 is also not reported in the registry record.
Safety interpretation is limited by the lack of a concurrent comparator and by insufficient detail about the meaning and denominator of the serious-event term percentages. The record does not establish causal attribution or explain overlap among event categories. These limitations are specific to the information recorded and should not be replaced with assumptions about the protocol or unreported results.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Doxorubicin (Doxil) Combined With Rituxan, Cyclophosphamide, Vincristine and Prednisone in Newly Diagnosed Aggressive Non-Hodgkin's Lymphomas — NCT00184002.
- Registry record last updated 2017-08-10; status last verified 2017-07.
- Results first posted 2017-08-10.
- 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
NCT00184002 is a completed phase II, single-group study sponsored by the University of Southern California. The registry records enrollment of 68 participants with non-Hodgkin's lymphoma and evaluates DR-COP: Doxil, rituximab, cyclophosphamide, vincristine and prednisone. Allocation is listed as not applicable and masking as none.
The primary endpoint is the percentage of participants with complete response at completion of cycles 4, 6 and 8. Initial response assessment was planned after cycle 4; later assessment and treatment continuation depended on response. The primary numerical response result and statistical analysis are not reported in the registry record.
The DR-COP safety record lists 35 participants with serious adverse events, 27 with other adverse events, and 3 deaths. Serious-event terms are also listed with percentages. The registry does not provide a concurrent control group, so the study record supports descriptive interpretation rather than a direct comparison with another regimen.