Feasibility Study of a 60 Minute Rapid Infusion Rituximab Protocol in Patients With B-cell Malignancies: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Feasibility Study of a 60 Minute Rapid Infusion Rituximab Protocol in Patients With B-cell Malignancies (NCT01206777), a na phase 2 study. The primary outcome is Incidence of Grade III and IV Hypersensitivity Reactions.

2. Clinical Question

3. Trial Design

This was a Phase 2, single-group study of a rapid infusion rituximab protocol. The registry record lists an enrollment of 52 and identifies the sponsor as Ohio State University Comprehensive Cancer Center. The study is marked completed. Its stated purpose was to assess whether a 60 minute infusion protocol was feasible in the institution's outpatient infusion center.

The design does not include a randomized comparison. Allocation is listed as not applicable, and masking is listed as none. Accordingly, the design is suited to describing experience with the protocol in the enrolled group, but it does not by itself provide a like-for-like estimate of how outcomes would differ under another infusion approach. The secondary outcome concerning time savings uses predicted infusion time under a standard second dose titration schedule; the record does not describe that prediction as a concurrent control group.

The registry record lists a start date of 2010-10 and primary completion in 2013-04. The study condition is described as indolent or intermediate grade B-cell malignancy, and the official title names B-cell non-Hodgkin's lymphoma and chronic lymphocytic leukemia. The record lists rituximab as the drug intervention but does not provide an arm description or further protocol details in the arm entry.

Two secondary outcomes are named: time savings relative to predicted infusion time using the standard second dose titration schedule, and nursing satisfaction with rapid infusion compared with standard titration practice. Their results are not reported in the registry record. Details of eligibility, recruitment, protocol deviations, and the number of participants included in each outcome analysis are also not reported in the registry record.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

Reasons for not completing this period:

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.

6. Primary Endpoint

The registry lists the primary outcome as Incidence of Grade III and IV Hypersensitivity Reactions, measured over Every 15 minutes from start of infusion until completion, for up to 1 hour.

The primary endpoint is the incidence of Grade III and IV hypersensitivity reactions, expressed as a percentage of patients. It addresses a specific safety and feasibility concern for a rapid rituximab infusion: whether reactions in the stated severity grades occurred during the protocol's observation period. The registry record specifies checks every 15 minutes from the start of infusion until completion, for up to 1 hour.

In general, a binary endpoint classifies each participant as having or not having the event under the endpoint definition. A percentage summarizes the event frequency in the group being assessed. Its interpretation depends on a clear event definition, a defined analysis population, and a denominator that matches the people observed for the endpoint. The registry record gives the endpoint title and unit but does not provide a more detailed definition, analysis population, or observed result.

The timing description identifies when reactions were to be assessed; it does not establish how many assessments were completed or how missing observations were handled. The registry record does not report the primary endpoint's numerator, denominator, estimate, or uncertainty interval. Therefore, the endpoint's result cannot be interpreted from the posted registry information.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry record identifies a binary percentage endpoint but does not report a statistical analysis plan or any analyses. The concepts below are general explanations of how such an endpoint is ordinarily interpreted; they are not claims about methods used in this study.

What does a binary percentage represent?

For a binary outcome, each participant is classified according to whether the specified event occurred. The event proportion is the number of participants classified as having the event divided by the number included in the outcome analysis. Expressing that proportion as a percentage makes the frequency easier to read, but does not by itself show how precise the estimate is. A complete report should identify both the event count and the analysis denominator, as well as how the event was defined.

For this study, the primary outcome is labeled as the incidence of Grade III and IV hypersensitivity reactions. The record specifies the unit as percentage of patients and gives the observation timing. It does not give the event count, denominator, or result. Although the study enrollment is 52, enrollment alone does not establish that all enrolled participants contributed data to this endpoint. The analysis population and handling of participants without complete observation are not reported in the registry record.

Why does precision matter?

In general, an estimate from a group is subject to sampling variability: another group drawn under similar conditions could produce a different observed proportion. A confidence interval expresses uncertainty around an estimate under the assumptions of the chosen method. It is not a guarantee that the true value lies in a particular range, and it does not account automatically for bias, incomplete follow-up, or differences between the study group and another population.

When an event is uncommon, the observed proportion can be especially sensitive to a small number of events. A zero count, if reported for a clearly defined endpoint and denominator, would not establish that the underlying event probability is zero. It would describe what was observed in that group. For this study, the adverse-event summary reports zero affected in its listed categories, but the primary hypersensitivity outcome itself is not reported. Those entries should not be substituted for the primary result.

What can a single-group design estimate?

In general, a single-group study can estimate or describe the outcome frequency among participants assessed under the study protocol. Without a concurrent comparison group, it cannot directly estimate a between-group contrast under the same study conditions. Observed outcomes can reflect the protocol and other features of the participants, setting, care, or measurement process. This is why the design matters when interpreting a result: descriptive frequency and comparative effect are different questions.

The record lists no randomized allocation and no masking. It therefore does not describe a blinded randomized comparison. The secondary measure of time savings is worded as a comparison with predicted infusion time using a standard second dose titration schedule. In general, a predicted reference is not equivalent to outcomes observed in a concurrent control group; interpretation depends on how the prediction was constructed and validated. Those details and the secondary outcome result are not reported in the registry record.

What does the record say about statistical testing?

The number of listed analyses is zero. The registry record does not report a hypothesis test, p-value, confidence interval, or model for the primary outcome. It also does not report whether any adjustment, subgroup analysis, or interim analysis was planned or performed. None should be inferred from the endpoint title or from the fact that the study is Phase 2.

In general, a p-value addresses how compatible observed data are with a specified statistical model and null hypothesis; it does not measure the probability that a treatment works, nor does it describe the size or practical importance of an effect. A confidence interval and an estimate are often more informative for judging magnitude and precision. Since these results are not reported in the registry record, there is no inferential result to interpret for the primary endpoint.

How should planning calculations be understood?

In general, sample-size planning asks how many participants might be needed to detect a stated effect under specified assumptions. Such a calculation is a planning illustration, not an observed result and not evidence that a study had a particular probability of detecting its true effect after completion. The registry record's planning description refers to an effect based on an observed effect and specified assumptions, but it does not report the observed primary outcome estimate in the outcome information. Without the estimate and the calculation outputs, no numerical planning result or its sensitivity to assumptions can be interpreted. Planning figures should not be presented as observed power.

Over-dispersion is a general concern when outcome variability exceeds what a statistical model assumes; if ignored, estimated uncertainty may be too small. It is not possible to say whether over-dispersion applies to this study because no fitted model or dispersion assessment is reported in the registry record. More broadly, the absent analysis details mean that the statistical methods actually used cannot be reconstructed from the registry entries.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Rituximab")
n      <- c(50)
events <- c(0)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Rituximab  50  0  0.0  0.0  7.1  0.0  7.1  0.0  7.0

11. Multiplicity, Missing Data and Analysis Populations

The registry record names one primary outcome and two secondary outcomes. The primary measure concerns Grade III and IV hypersensitivity reactions. The secondary measures concern time savings relative to predicted infusion time under a standard second dose titration schedule and nursing satisfaction with rapid infusion relative to standard titration practice. Their results are not reported in the registry record.

When a study assesses multiple outcomes, multiplicity can arise because several statistical questions are considered. In general, testing many hypotheses without an appropriate strategy can increase the chance of at least one apparently unusual result under the null assumptions. Methods for handling multiplicity may include defining a primary outcome in advance, adjusting tests, or treating secondary analyses as exploratory. The registry record does not report a multiplicity strategy, planned tests, or test results, so it is not possible to determine how multiplicity was addressed.

The record lists zero analyses. It does not report an analysis population for the primary endpoint or secondary outcomes, and it does not state how missing observations, withdrawals, or incomplete infusion assessments were handled. The primary outcome specifies repeated observation timing, but the registry record does not give the number of completed assessments or a missing-data method. Enrollment of 52 should not be assumed to equal the number analyzed for every outcome.

In general, missing-data handling can affect an estimate when participants with missing outcomes differ from those with observed outcomes. A transparent report would identify the analysis population, outcome-specific denominators, missingness, and any assumptions or sensitivity analyses. These details are not reported in the registry record. Their absence limits assessment of the completeness and robustness of any outcome result; in this case, the primary and secondary outcome results themselves are also not reported.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

The registry safety summary lists the rituximab group with 50 participants at risk for serious adverse events and zero affected. It also lists 50 at risk for other adverse events and zero affected. These are the posted counts for those categories. The summary does not list any serious adverse-event terms.

These safety entries should be read separately from the primary endpoint, which is the incidence of Grade III and IV hypersensitivity reactions. The registry record does not establish that the serious-event and other-event categories correspond to that specific endpoint, nor does it provide a crosswalk between the definitions. The safety counts therefore cannot be used as the missing primary outcome result.

In general, a count of zero affected describes no recorded events in the listed category among the stated participants at risk; it does not establish that the event is impossible or that the underlying risk is zero. Interpretation also depends on the duration and completeness of follow-up and on how events were collected. Those details are not reported in the registry record. The safety counts are descriptive and do not, on their own, establish comparative safety because the study has no separate control group.

13. What the Result Does, and Does Not, Mean

The registry record documents a study designed to assess the feasibility of a 60 minute rapid infusion rituximab protocol in an institution's outpatient infusion center. It identifies the primary safety outcome and two secondary outcomes. It also records enrollment of 52 and gives adverse-event counts for 50 participants at risk in each of two categories. These details describe the study's purpose and selected registry entries, but they are not a complete report of the outcome findings.

The key limitation for interpreting the primary question is that the result for Grade III and IV hypersensitivity reactions is not reported in the registry record. The record gives no primary event count, denominator, percentage, or confidence interval. Thus, the posted information does not show the observed primary endpoint frequency or its precision. The secondary outcome results are likewise not reported, so time savings and nursing satisfaction cannot be characterized from these entries.

The zero counts in the safety summary apply to its listed serious and other adverse-event categories. They do not establish the primary endpoint result, and they do not demonstrate that risk is absent. In general, zero recorded events in a study group is a description of the observed data, not proof of a zero underlying event probability. Follow-up completeness and event ascertainment details are not reported in the registry record.

The design also constrains what could be concluded even if outcome estimates were available. This is a single-group study without a randomized comparator. It can describe experience in the enrolled group, but it does not directly estimate how outcomes compare with a concurrent group receiving standard titration. The predicted infusion time named in a secondary outcome is not a randomized control arm.

Accordingly, the registry record supports a description of the question, design, and listed safety counts. It does not support a conclusion about the magnitude or precision of the primary outcome, a comparative effect, or the secondary outcomes. The appropriate interpretation is bounded by these reporting gaps and the non-comparative design.

14. Why This Trial Matters Statistically

This trial is statistically informative as an example of the difference between a clear study question and a complete set of reported results. The registry record specifies a single-group feasibility study, identifies a binary primary safety endpoint, and gives a schedule for observing that endpoint. Yet it does not report the primary event count, denominator, or estimate. Without those elements, the central outcome cannot be evaluated quantitatively.

The distinction between enrollment and analysis is important. The registry record lists enrollment of 52, while the adverse-event summary lists 50 at risk in each category. These figures refer to different record entries; the registry does not state that the safety denominators are the primary outcome denominator. In general, outcome-specific populations and denominators are needed to interpret proportions and to understand whether participants were omitted from an analysis.

The design also illustrates why a comparator matters. A single-group study can describe event frequencies and operational experience in its enrolled group, but it cannot directly estimate a comparative effect against standard titration. The time-savings outcome refers to a predicted infusion time, which is conceptually different from a concurrent group observed under another protocol. Statistical interpretation should match the question the design can answer.

Finally, the safety counts show why endpoint definitions must remain distinct. The adverse-event summary and the primary hypersensitivity endpoint are not interchangeable simply because both relate to safety. Their definitions, observation periods, and analysis populations would need to be aligned before treating them as the same measure; that alignment is not reported in the registry record. Clear endpoint reporting, denominators, and uncertainty estimates are essential for readers to assess both the observed frequency and its precision.

15. 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.

Several limitations are specific to the information reported for this study. The registry record does not report the primary endpoint result, even though it identifies the endpoint and its observation schedule. The event count, denominator, and estimate are absent, as is a confidence interval. This prevents quantitative assessment of the study's principal outcome.

The record lists enrollment of 52 but does not state how many participants contributed to the primary outcome analysis. The adverse-event summary reports 50 at risk in its serious-event category and 50 at risk in its other-event category; those figures do not identify the primary endpoint denominator. The record also does not explain any difference between enrollment and the safety risk sets.

The design is single group, with no randomized comparator, and masking is listed as none. Therefore, even a reported event frequency would describe the enrolled group rather than provide a randomized estimate of a difference between infusion approaches. The secondary time comparison uses predicted infusion time, but the method for constructing that prediction is not reported in the registry record.

The primary outcome's assessment schedule is stated, but the detailed event definition, completeness of observation, and handling of missing assessments are not reported. The results for both secondary outcomes are also not reported. The registry lists no analyses and does not describe a statistical analysis plan, multiplicity approach, or analysis populations. Finally, the zero adverse-event counts should not be generalized beyond their listed categories or interpreted as proof that no risk exists. Together, these gaps limit both the statistical interpretation and the scope of any conclusions from the registry entries.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Feasibility Study of a 60 Minute Rapid Infusion Rituximab Protocol in Patients With B-cell Malignancies — NCT01206777.
• Registry record last updated 2017-12-20; status last verified 2017-12.
• Results first posted 2015-02-23.
• 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.

19. Record Summary

The registry record describes NCT01206777, a completed Phase 2, single-group feasibility study sponsored by Ohio State University Comprehensive Cancer Center. It lists enrollment of 52 and a 60 minute rapid infusion rituximab protocol for people with indolent or intermediate grade B-cell malignancy. The stated purpose was to assess feasibility in an outpatient infusion center.

The primary outcome was incidence of Grade III and IV hypersensitivity reactions, with observation every 15 minutes from infusion start until completion, for up to 1 hour. Secondary outcomes concerned time savings relative to predicted standard titration time and nursing satisfaction. Results for these outcomes are not reported in the registry record. The safety summary lists zero affected among 50 at risk in each of its serious and other adverse-event categories. No analyses are listed.