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 to Evaluate Safety, Efficacy and Pharmacokinetics of Rituximab (MabThera/Rituxan) in Participants With Diffuse Large B Cell Lymphoma (DLBCL) or Follicular Lymphoma (FL) (NCT01889069), a na phase 3 study. The primary outcome is Percentage of Participants With Administration-Associated Reactions (AAR).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01889069 |
| Phase | Phase 3 |
| Condition | Lymphoma |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 159 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Hoffmann-La Roche |
| Results posted | Yes |
2. Clinical Question
Population
Previously untreated participants with CD20-positive diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL). The registry defines the primary safety population as enrolled participants who received at least one dose of study medication.
Intervention
Subcutaneous rituximab alongside standard chemotherapy. The planned schedule described at least 4 doses of rituximab 1400 mg once a month during induction, and at least 6 doses of 1400 mg once every two months during maintenance.
Comparator
There was no separate comparison group. The study is described as single arm, with no allocation to different treatment arms; a concurrent control group is not reported in the registry record.
Primary question
What percentage of participants experienced an administration-associated reaction (AAR) from baseline up to 54 months? AARs were adverse events within 24 hours of rituximab administration that were considered related to study drug. The registry record does not report the primary outcome result.
3. Trial Design
This completed study is registered as a phase IIIB, multicentre, single-group study. It enrolled 159 participants and concerned previously untreated participants with CD20-positive DLBCL or FL. The study evaluated safety, efficacy and pharmacokinetics of subcutaneous rituximab administered during induction or maintenance. The registry record gives a start date of 2013-07-31 and a primary completion date of 2019-05-28.
Participants were to receive rituximab in addition to standard chemotherapy. The described rituximab schedule was at least 4 doses of 1400 mg once a month during induction, followed by at least 6 doses of 1400 mg once every two months during maintenance. The listed interventions include rituximab, cyclophosphamide, vincristine, doxorubicin, prednisone and bendamustine. The brief description refers to standard chemotherapy, while the arm description gives only a partial description of the chemotherapy regimen; the full regimen details are not reported in the registry record.
Because this is a single-arm study, the participants do not form a randomized comparison against a separate control group. The study can describe outcomes among treated participants, but its design does not provide a direct estimate of how those outcomes would differ under another treatment. The registry record lists safety, efficacy and pharmacokinetic objectives, but details of the pharmacokinetic analyses are not reported.
The registry reports 159 enrolled participants. That enrollment figure is distinct from the outcome-specific denominators in the adverse-event results: the DLBCL group has 72 participants at risk in the serious and other adverse-event fields, and the FL group has 86. The registry record does not explain in the registry record how those outcome denominators relate to the total enrollment.
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: Total overall participants enrolled in the study was 159, however for the subject disposition and baseline characteristics the enrolled was 158 as one participant discontinued the study prior to treatment.
Overall Study
| Stage | Subcutaneous (SC) Rituximab |
|---|---|
| STARTED | 158 |
| COMPLETED | 113 |
| NOT COMPLETED | 45 |
Reasons for not completing this period:
| Reason | Subcutaneous (SC) Rituximab |
|---|---|
| Death | 18 |
| Progression of Disease | 14 |
| Lost to Follow-up | 6 |
| Other | 4 |
| Consent Withdrawal | 3 |
Analysis population for the primary outcome, as defined in the registry: Safety Population included all enrolled participants who received at least one dose of study medication.
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: ITT population included all enrolled participants. All analyses described have been performed by type of lymphoma (DLBCL/ FL) and overall. Total overall participants enrolled in the study was 159, however for the subject disposition and baseline characteristics the enrolled was 158 as one participant discontinued the study prior to treatment.
| Characteristic | Unit | Diffuse Large B-Cell Lymphoma (DLBCL) | Follicular Lymphoma (FL) | Total |
|---|---|---|---|---|
| Participants analysed | 72 | 86 | 158 | |
| Age, Continuous: Intent-to-Treat Population | years | 59.7 (SD 12.70) | 57.8 (SD 9.92) | 58.7 (SD 11.28) |
| Sex: Female, Male: Female | Participants | 28 | 44 | 72 |
| Sex: Female, Male: Male | Participants | 44 | 42 | 86 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 4 | 5 | 9 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 59 | 72 | 131 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 9 | 9 | 18 |
6. Primary Endpoint
The registry lists the primary outcome as Percentage of Participants With Administration-Associated Reactions (AAR), measured over Baseline up to 54 months.
| 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 an administration-associated reaction from baseline up to 54 months. The registry defines an AAR as an adverse event occurring within 24 hours of rituximab administration and considered related to study drug. This definition includes infusion or injection-related reactions, injection-site reactions, administration-site conditions and their symptoms. Severity grading was based on National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0.
This endpoint is intended to capture reactions temporally close to administration and judged related to study drug. A percentage expresses how common the defined event was among the population used for the analysis; it does not by itself describe how severe events were, how long they lasted, or whether they caused treatment interruption. Those details require separate outcome reporting.
The registry defines the primary endpoint population as the Safety Population: enrolled participants who received at least one dose of study medication. This definition does not establish how participants with incomplete follow-up or missing endpoint information were handled. That approach is not reported in the registry record.
Although the endpoint and its observation period are specified, the registry record does not report the percentage of participants with AARs, an event count for this primary endpoint, or a statistical estimate of its uncertainty. The posted information therefore defines what was intended to be measured but does not give the primary result.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central interpretive point is that the registry describes the study design and outcome definitions, but does not report formal analysis results for the primary endpoint. The primary question concerns AARs through 54 months in a safety population defined by receipt of at least one dose. No primary AAR percentage, count, confidence interval or analysis result is reported in the registry record. The listed outcome definition should not be mistaken for evidence about the observed frequency of that outcome.
The adverse-event fields do provide descriptive counts by lymphoma group. For DLBCL, 26 of 72 participants are recorded in the serious adverse-event fields, and 50 of 72 in the other adverse-event fields. For FL, the corresponding figures are 23 of 86 and 56 of 86. These are group-specific counts from the posted record. They do not constitute a randomized treatment comparison, and the available information does not establish whether the groups are comparable on prognostic or clinical characteristics.
The record also lists serious adverse-event terms with percentages: Neutropenia, 20.8%; Neutrophil Count Decreased, 6.9%; Febrile Neutropenia, 5.6%; Pneumonia, 2.8%; White Blood Cell Count Decreased, 2.8%; and Lymphopenia, 2.3%. The denominator and analytic details for these percentages are not reported in the registry record presented in the registry record. They should therefore be read as posted descriptive values, not as estimates adjusted for follow-up or differences between groups.
Deaths are recorded as 14 in the DLBCL group and 4 in the FL group. The available record does not specify the causes, timing, relationship to treatment, or analytic role of these deaths. They cannot be interpreted as treatment-related deaths from these counts alone.
The single-arm design limits causal interpretation. Outcomes observed during a regimen that combines rituximab with chemotherapy cannot distinguish the contribution of each treatment component. Without a concurrent control group, the data do not estimate how safety or efficacy would compare with another regimen. The efficacy outcomes are named in the registry, including event-free survival, progression-free survival, overall survival, disease-free survival and complete response, but their results are not reported in the registry record.
Accordingly, the posted information supports a description of the registered design, endpoint definitions and available adverse-event counts. It does not support a conclusion about comparative efficacy, comparative safety, or the size or precision of the primary endpoint result.
9. Statistical Methods Explained
What does a single-arm design estimate?
In a single-arm study, participants receive the study regimen and outcomes are described within that treated group. Such a design can characterize observed events and follow-up outcomes, but it does not directly estimate a treatment contrast against a concurrent control group. A causal comparison asks how outcomes would differ under alternative treatment choices. Because the same participants cannot be observed under both choices and this study has no randomized comparator, that contrast is not identified by the study design alone. Differences between observed outcomes and external expectations would also be vulnerable to differences in population, care, outcome definitions and follow-up.
The registry calls this a single-group study with allocation listed as not applicable and masking listed as none. No randomization or blinded assessment is reported. The absence of a control group is particularly important when interpreting safety and efficacy: events occurring during treatment can be counted, but the study design alone cannot show how many would have occurred without the regimen or under another regimen.
How should a percentage endpoint be understood?
A percentage of participants with an event is a binary outcome summary: each participant is classified according to whether the defined event occurred within the relevant assessment period. The primary AAR definition uses a time window after rituximab administration, a relation-to-study-drug criterion, and inclusion of several reaction types. Those definition elements determine which events count. Changing the event definition or the assessment period could change the summary, so the definition is part of the result rather than a minor technical detail.
A percentage alone does not express precision. A confidence interval is a statistical range used to show uncertainty around an estimate under a specified analysis model. Wider intervals generally indicate less precision, while narrower intervals indicate greater precision, subject to the assumptions used. No confidence interval or primary percentage is reported in the registry record, so the precision of the primary endpoint cannot be assessed from the posted results.
Why do denominators matter?
For a percentage, the denominator identifies the group of participants to whom the estimate applies. This study defines its primary safety population as enrolled participants who received at least one dose. The adverse-event fields give separate denominators for DLBCL and FL. Those group-specific denominators should not automatically be treated as the denominator for every other endpoint. Different outcomes can have different analysis populations, follow-up requirements or available data. The registry record does not give further details on those distinctions for the outcomes whose results are not posted.
Even when a denominator is stated, it is important to know whether everyone in it had complete observation for the full period. In longer follow-up, participants may have different observation times, and a simple participant percentage can be difficult to interpret if follow-up differs. Time-to-event methods can account for varying observation and censoring under assumptions, but the relevant analysis methods and results for the listed survival outcomes are not reported in the registry record.
What do the adverse-event counts tell us?
The serious and other adverse-event fields are descriptive counts in each lymphoma group. They communicate how many participants are recorded as affected among the stated group denominator. They do not convey event timing, recurrence, duration, severity distribution beyond the serious classification, or causal attribution unless those details are separately defined and reported. The registry’s primary endpoint has its own explicit relation-to-study-drug criterion; the adverse-event counts should not be assumed to use that same definition.
The listed serious-event terms have percentages, but the denominator and calculation details are not reported in the registry record. A term-specific percentage may refer to participants, events or another analysis basis; without a stated denominator and definition, the reader should not infer which. The values are best treated as the record’s reported descriptive percentages, with their scope left uncertain.
What does multiplicity mean in this study?
Multiplicity arises when many outcomes or statistical tests are considered. If each test is interpreted in isolation, the chance of at least one apparently notable result across a collection of tests can be greater than for a single pre-specified test. Methods to address this issue may include defining a hierarchy of outcomes, adjusting inferential thresholds, or treating analyses as exploratory. Which approach is appropriate depends on the study plan and the intended claims.
The registry lists a range of secondary outcomes, including safety events and response or survival outcomes, but the statistical plan for handling multiple outcomes is not reported in the registry record. No p-values, confidence intervals or effect estimates are reported in the registry record for interpretation. It is therefore not possible to assess how multiplicity was handled or whether any formal inferential procedure was used.
How should planning illustrations be separated from results?
Sample-size illustrations based on an observed effect are planning calculations, not evidence that a study had a specified probability of detecting an effect. The record describes illustrative assumptions of a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It also describes detecting a stated fraction of an observed effect; time-to-event illustrations use a total event count, while other illustrations use participants per arm. These assumptions belong to the planning illustration and do not describe the actual single-arm allocation of this trial.
In particular, an illustration that assumes equal allocation between two arms does not turn a single-arm study into a two-arm comparison, and a sample-size illustration is not observed power. No sample-size justification for the trial itself is reported in the registry record. No result-specific effect estimate is available in the record to support interpretation of a planning illustration as a trial finding.
Overall, the methods information permits interpretation of the endpoint definitions and the limits of the design. The absence of posted analysis estimates means that statistical precision, model fit, adjusted effects and the handling of incomplete outcome data cannot be evaluated from the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists multiple secondary outcomes in addition to the primary AAR endpoint. These include the percentage of participants with grade 3 or higher treatment-emergent adverse events, grade 3 or higher infusion or injection-related reactions, treatment-emergent serious adverse events, event-free survival, progression-free survival, overall survival, disease-free survival and complete response. The record states that there are 21 outcome measures, but the analysis results for these outcomes are not reported in the registry record.
When many outcomes are assessed, multiplicity can affect how strongly individual statistical findings should be interpreted. A pre-specified testing hierarchy or another adjustment can help control the chance of misleading findings from repeated testing. The statistical plan for multiplicity, including whether any adjustment or hierarchy was used, is not reported in the registry record. No interim analyses or stopping rules are reported in the registry record.
Missing-data methods are also not reported. The registry defines the primary safety population as participants who were enrolled and received at least one dose, but it does not state how participants with missing endpoint assessments, incomplete follow-up, or discontinuation were handled in the primary analysis. The analysis populations for the other outcomes are not described in the registry record. It is also not reported whether missing values were excluded, imputed, or addressed by another approach.
These omissions matter because an event percentage depends on both the event definition and the participants included in its denominator, while survival outcomes depend on follow-up and censoring rules. Without those details and the outcome estimates, readers cannot assess the influence of incomplete data or reconstruct the intended inferential framework.
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 |
|---|---|---|---|
| Diffuse Large B-Cell Lymphoma (DLBCL) | 26 | 72 | 36.1% |
| Follicular Lymphoma (FL) | 23 | 86 | 26.7% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Diffuse Large B-Cell Lymphoma (DLBCL) | 14 of 72 |
| Follicular Lymphoma (FL) | 4 of 86 |
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 |
|---|---|
| Diffuse Large B-Cell Lymphoma (DLBCL) | 50 of 72 |
| Follicular Lymphoma (FL) | 56 of 86 |
Most frequent serious adverse event terms
| Event term | Organ system | Diffuse Large B-Cell Lymphoma (DLBCL) | Follicular Lymphoma (FL) |
|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | 15 of 72 | 13 of 86 |
| Febrile Neutropenia | Blood and lymphatic system disorders | 4 of 72 | 2 of 86 |
| Neutrophil Count Decreased | Investigations | 5 of 72 | 1 of 86 |
| Leukopenia | Blood and lymphatic system disorders | 1 of 72 | 1 of 86 |
| Lymphopenia | Blood and lymphatic system disorders | 0 of 72 | 2 of 86 |
| Thrombocytopenia | Blood and lymphatic system disorders | 0 of 72 | 2 of 86 |
| Acute Coronary Syndrome | Cardiac disorders | 1 of 72 | 1 of 86 |
| Cholecystitis Acute | Hepatobiliary disorders | 0 of 72 | 2 of 86 |
| Cholelithiasis | Hepatobiliary disorders | 0 of 72 | 2 of 86 |
| Pneumonia | Infections and infestations | 2 of 72 | 0 of 86 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Diffuse Large B-Cell Lymphoma (DLBCL) | Follicular Lymphoma (FL) |
|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | 21 of 72 | 20 of 86 |
| Pyrexia | General disorders | 11 of 72 | 15 of 86 |
| Cough | Respiratory, thoracic and mediastinal disorders | 6 of 72 | 15 of 86 |
| Anaemia | Blood and lymphatic system disorders | 11 of 72 | 6 of 86 |
| Asthenia | General disorders | 14 of 72 | 3 of 86 |
| Paraesthesia | Nervous system disorders | 9 of 72 | 7 of 86 |
| Diarrhoea | Gastrointestinal disorders | 7 of 72 | 7 of 86 |
| Influenza Like Illness | General disorders | 2 of 72 | 9 of 86 |
| Neutrophil Count Decreased | Investigations | 9 of 72 | 1 of 86 |
| Headache | Nervous system disorders | 3 of 72 | 7 of 86 |
Serious events with the highest arm-level rate: neutropenia (20.8%), neutrophil count decreased (6.9%), febrile neutropenia (5.6%), pneumonia (2.8%), white blood cell count decreased (2.8%).
The registry reports adverse-event counts separately for the DLBCL and FL groups. In DLBCL, 26 of 72 participants are recorded in the serious adverse-event fields and 50 of 72 in the other adverse-event fields. In FL, the corresponding counts are 23 of 86 and 56 of 86. These counts describe the record’s group-specific classifications; they are not a comparison of randomized treatment groups.
The listed serious-event terms and percentages are Neutropenia, 20.8%; Neutrophil Count Decreased, 6.9%; Febrile Neutropenia, 5.6%; Pneumonia, 2.8%; White Blood Cell Count Decreased, 2.8%; and Lymphopenia, 2.3%. The registry entries do not specify the denominator or calculation method for those term-specific percentages. They should not be treated as group-specific figures unless the record explicitly defines them that way.
Deaths are listed as 14 in the DLBCL group and 4 in the FL group. The registry entries do not state their causes, timing or relationship to study treatment. These figures alone cannot establish that deaths were caused by treatment. More broadly, counts do not describe event duration, recurrence, or comparative risk, and the single-arm design supplies no concurrent control group for estimating a treatment-related excess.
12. What the Result Does, and Does Not, Mean
The results that can be described from the registry concern the study’s design, endpoint definitions and the adverse-event counts recorded by lymphoma group. The primary endpoint was defined as the percentage of participants with AARs from baseline up to 54 months, using a safety population of participants who received at least one dose. The primary endpoint result itself is not reported in the registry record.
The adverse-event figures give descriptive counts in the DLBCL and FL groups, and the record lists several serious-event terms with percentages. These entries can inform a reader about what the registry reports, but their interpretation is limited by missing details about term-specific denominators and analysis methods. The counts do not, by themselves, measure comparative risk, establish causation, or explain whether events were related to treatment.
The study’s single-arm structure is central to what can and cannot be inferred. Participants received rituximab with chemotherapy, so observed outcomes cannot isolate the effect of rituximab from the other treatment components. There is no concurrent comparison group to show how outcomes would differ under an alternative treatment. The record does not support a comparative claim about safety or efficacy.
The registry lists efficacy outcomes, including response and survival measures, but does not report their analysis results in the information. Nor does it report a primary AAR estimate or its uncertainty. Consequently, readers cannot judge the magnitude or precision of the primary outcome, or the statistical evidence for the listed efficacy outcomes.
This distinction is important: an endpoint definition says what investigators intended to measure, while a result requires an observed estimate and enough analytic detail to understand its population and uncertainty. The registry record contains the former for the primary endpoint, but not the latter. The adverse-event summaries should be read as descriptive registry entries, not as proof that a treatment caused or prevented any outcome.
13. Why This Trial Matters Statistically
This study is statistically informative as an example of why design and reporting details determine the strength of a clinical conclusion. Its single-arm structure allows outcomes to be described among treated participants, but it does not support a direct randomized comparison. The regimen includes rituximab with chemotherapy, so any observed event or response cannot be attributed to rituximab alone from this design.
The primary AAR endpoint also illustrates how operational definitions shape a safety measure. The registry specifies a time window of 24 hours after administration, a judgment that the event was related to study drug, and inclusion of infusion or injection-related reactions, injection-site reactions and administration-site conditions. These rules make the intended outcome more interpretable, but an outcome definition cannot substitute for a reported estimate.
Another statistical lesson is that group counts and percentages require a clear denominator and scope. The serious and other adverse-event fields have group-specific denominators, while the listed serious-event term percentages do not have denominator details in the available record. That difference affects how confidently readers can interpret or compare the summaries. Counts should not be converted into comparative claims without a suitable design and a clearly defined analysis.
The record also names several secondary outcomes and gives no analysis results for them in the registry record. When multiple outcomes are considered, a statistical plan is needed to explain which results are confirmatory and how multiplicity is addressed. Similarly, missing-data and follow-up rules are necessary to understand the analysis populations and the interpretation of longer-term outcomes. Those details are not reported in the registry record.
Thus, the record is useful for identifying the registered question, treatment schedule, endpoint definition and some descriptive safety information. Its limits are equally important: the primary result, analysis precision, comparative effects and details of the statistical plan are not reported. A disciplined reading separates what was planned and defined from what the posted results actually establish.
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 absence of a separate control group is a major limitation for comparative interpretation. The study’s single-arm design cannot estimate a randomized contrast, and the combination of rituximab with chemotherapy prevents attribution of observed outcomes to one treatment component. The lymphoma groups are not described as randomized arms, so their outcome counts should not be read as a treatment comparison.
The primary endpoint result is not reported in the registry record. Although the AAR definition, time frame and safety population are specified, the record does not give the observed primary percentage, event count or uncertainty estimate. Efficacy outcomes are listed, but their results are also not reported in the registry entries. This leaves the main quantitative questions unanswered.
The adverse-event information has further interpretive limits. The serious and other adverse-event fields provide counts by group, but additional information about event timing, severity detail, treatment relationship and follow-up is not given. The serious-event term percentages lack a stated denominator and calculation method in the available record. Death counts are listed without causes, timing or relationship to treatment.
The registry record does not report the sample-size justification for this trial, the statistical plan, multiplicity handling, missing-data procedures, interim analyses or detailed analysis populations beyond the defined safety population. The planned chemotherapy regimen is only partially described in the arm information, and pharmacokinetic analysis details are not reported. These limits restrict assessment of precision, robustness and reproducibility.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study to Evaluate Safety, Efficacy and Pharmacokinetics of Rituximab (MabThera/Rituxan) in Participants With Diffuse Large B Cell Lymphoma (DLBCL) or Follicular Lymphoma (FL) — NCT01889069.
- Registry record last updated 2020-08-13; status last verified 2020-07.
- Results first posted 2020-08-13.
- 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
NCT01889069 is a completed, phase IIIB, multicentre, single-arm study of subcutaneous rituximab with chemotherapy in previously untreated participants with CD20-positive DLBCL or FL. The registry reports 159 enrolled participants. The described schedule included at least 4 monthly induction doses and at least 6 maintenance doses every two months, each dose 1400 mg.
The primary endpoint was the percentage of participants with administration-associated reactions from baseline up to 54 months. The endpoint definition and Safety Population are described, but the primary result is not reported in the registry record. Descriptive adverse-event counts are listed by lymphoma group, along with serious-event terms and percentages. Efficacy outcome results, analysis methods, missing-data handling and the statistical plan are not reported in the registry record for interpretation.