Bevacizumab, Radiation Therapy, and Cisplatin in Treating Patients With Previously Untreated Locally Advanced Cervical Cancer: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Bevacizumab, Radiation Therapy, and Cisplatin in Treating Patients With Previously Untreated Locally Advanced Cervical Cancer (NCT00369122), a na phase 2 study. The primary outcome is Number of Subjects With Treatment-related Serious Adverse Events (SAEs) and Adverse Events (AEs) as Assessed by CTCAE v. 3.0 Criteria Within the First 90 Days From Treatment Start..

2. Clinical Question

The clinical question is primarily about treatment-associated safety during the specified observation window. The primary outcome counts participants meeting the registry’s event definitions; it is not a direct measure of tumor response or survival. Disease-free survival and overall survival are listed as secondary outcomes, with three-year rates reported, but the numerical results for those outcomes are not included in the record details.

The study’s treatment combination and the specified population define what the safety findings can address. They do not establish what would have happened to comparable participants receiving a different regimen, because there is no randomized or concurrent comparison group. The registry’s question therefore concerns the frequency of recorded events in the treated group, rather than a causal estimate of the difference between treatments.

3. Trial Design

The registry describes NCT00369122 as a phase II, single-group study sponsored by the National Cancer Institute. The study is marked completed. Its recorded start date is 2006-08-11, and its primary completion date is 2010-06-04. Enrollment is listed as 60 participants. The trial has no masking, and allocation is listed as not applicable, consistent with the single-group design.

The treatment group received bevacizumab, cisplatin, and radiation therapy. The intervention list includes external beam and internal radiation therapy. The arm description specifies pelvic external beam radiation therapy once daily, five days a week, for five weeks, for a total of 45 Gy. It also describes brachytherapy options, but the registry text available for those details is incomplete. No additional regimen details should be inferred from that partial description.

The primary outcome concerns the number of participants with treatment-related serious adverse events and adverse events assessed using CTCAE version 3.0 from treatment start to 90 days. The registry identifies the population for this outcome as eligible patients who began study treatment. It also lists treatment-related safety outcomes over any time, disease-free survival, and overall survival among the secondary outcomes.

A single-group study can describe observed outcomes in people who received the regimen, but it does not provide a like-for-like control for estimating comparative effects. The record does not report a separate randomized arm or a blinded assessment process. Details of the protocol’s sample-size justification, interim analyses, and full statistical analysis plan are 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:

Analysis population for the primary outcome, as defined in the registry: Eligible patients who began study treatment.

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 Number of Subjects With Treatment-related Serious Adverse Events (SAEs) and Adverse Events (AEs) as Assessed by CTCAE v. 3.0 Criteria Within the First 90 Days From Treatment Start., measured over From start of treatment to 90 days..

The primary endpoint counts participants who experienced treatment-related serious adverse events and adverse events during the period from treatment start to 90 days. Events were graded using CTCAE version 3.0. The registry describes severity grades from mild through death related to an adverse event and gives specific criteria for which events qualify as treatment-related serious adverse events or treatment-related adverse events.

The endpoint is expressed as a participant count, rather than a measure of event severity averaged across participants or a time-to-event estimate. A participant can be counted if they meet the stated event criteria within the observation window. The registry’s definition includes particular high-grade events and specified treatment-related toxicities; it is not simply a count of every symptom or event recorded during care.

Safety endpoints of this kind are used to characterize harms observed during treatment and follow-up. In general, an observation window gives a defined period for counting events, while prespecified grading and attribution rules make the endpoint more consistent. These choices also limit its scope: events outside the window, or events not meeting the registry’s definitions, are not represented by this primary count.

The record gives a primary endpoint definition but does not include a separate numerical primary-outcome result in the information. The adverse-event summary separately lists serious-event and other-event counts. Those figures should be read as the posted safety summary, not assumed to contain every detail needed to reconstruct the primary endpoint analysis.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The design and outcome scale determine what statistical statements can be supported. This trial has a single treatment group, and its primary endpoint is a participant count. The registry does not report a control group, a comparative estimate, or the statistical analysis plan in enough detail to identify a full inferential procedure for the primary endpoint.

What does a participant count represent?

A count records the number of people meeting an outcome definition. For a safety outcome, the definition may depend on event type, grade, attribution, and observation period. Here, the primary definition specifies treatment-related serious adverse events and adverse events graded with CTCAE version 3.0 during the period from treatment start to 90 days. The count therefore refers to participants who met those rules, not necessarily the total number of event episodes.

A count is easiest to interpret when its denominator and population are clear. The primary population is identified as eligible patients who began treatment. The safety summary reports 59 participants at risk for serious events and 59 at risk for other events. The record also lists enrollment of 60. These numbers refer to different registry entries, and the reason they differ is not reported in the registry record. They should not be silently substituted for one another.

Why does the single-group design matter?

General statistical explanation: a treatment comparison requires information about outcomes under at least two conditions, such as randomized treatment groups or a suitable external comparison. A single-group result describes what was observed among participants receiving the study regimen. It cannot directly estimate a difference between that regimen and another treatment, because there is no concurrent comparator in the design. Differences in patient characteristics, clinical care, or event ascertainment could also complicate comparisons with results from other studies.

The registry lists allocation as not applicable and the model as single-group. Consequently, the safety counts should be interpreted descriptively. They do not establish that the regimen caused every recorded event, and they do not quantify the excess or reduction in events relative to an alternative. The study also combines bevacizumab, cisplatin, and radiation therapy, so the observed event counts do not separate the contribution of each component.

How should precision be understood?

General statistical explanation: a confidence interval expresses the uncertainty around an estimate under a specified statistical model. A narrow interval indicates greater precision under that model; a wide interval indicates less precision. A point estimate alone does not show how much sampling uncertainty surrounds it. The registry information does not report a confidence interval for the primary safety count, so the precision of that count cannot be described using an interval from the record.

General statistical explanation: for a binary outcome, an analysis may report the number of participants with an event alongside the number assessed, and may also estimate the event proportion with an uncertainty interval. The registry’s count and at-risk figures allow the counts to be read as posted, but no additional estimate should be inferred where the registry has not reported it. In particular, no interval, hypothesis test, or adjusted estimate is described in the record summary.

What do the event definitions contribute?

The CTCAE version and treatment-related criteria define which events enter the endpoint. The record describes grade thresholds and examples, including specified bleeding, thrombotic, gastrointestinal, hematologic, and other toxicities. Standardized grading supports consistent classification, but interpretation still depends on complete event reporting and the rules used to attribute an event to treatment. The registry provides endpoint definitions; details on adjudication procedures are not reported in the registry record.

The reported leading serious-event terms are accompanied by percentages, but the record details do not state the term-specific counts or denominators. Those percentages should therefore be quoted as recorded rather than reverse-engineered into counts. The list is a selection of top serious terms, not a full description of every adverse event or its clinical course.

What is the planning illustration?

General statistical explanation: sample-size planning asks how many participants would be needed for a future study under specified assumptions about the effect to detect, significance level, allocation, and statistical model. A planning calculation is not an observed result and does not show the probability that this completed trial detected an effect. The registry’s described illustration uses a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; its target effect is expressed as a fraction of an observed effect. This hypothetical two-arm setup is not the actual single-group design.

The planning assumptions state that results for non-time-to-event outcomes are participants per arm, while time-to-event planning gives a total number of events. Such outputs, when reported, are planning illustrations rather than observed trial outcomes. They should not be described as observed power. The numerical planning outputs are not stated in the registry information, and the registry’s own design justification is not reported.

Over-dispersion is a general concern when variability exceeds what a simple model assumes, and can make standard errors too small if ignored. The record does not state that an over-dispersion model was relevant or used for this participant-count endpoint. No model should be attributed to the investigators without a reported analysis plan.

10. Multiplicity, Missing Data and Analysis Populations

Multiplicity concerns arise when a study evaluates multiple outcomes, time points, or statistical comparisons. Testing many hypotheses without an appropriate plan can increase the chance of at least one apparently notable result arising by chance. This trial lists four outcome measures and one analysis in the registry summary, including the primary safety endpoint and secondary outcomes for treatment-related adverse events, disease-free survival, and overall survival. The registry information does not report a multiplicity adjustment, a hierarchy for testing outcomes, or a detailed analysis plan. It is therefore not possible to determine from the record whether or how the investigators addressed multiplicity.

Missing-data methods are also not reported in the registry record. The safety summary gives 59 participants at risk for serious events and 59 at risk for other events, while the enrolled population is 60. The record does not explain the difference or state how participants with incomplete safety information were handled. No assumption about their event status should be made.

The primary endpoint population is described as eligible patients who began study treatment. The registry does not provide enough information to classify this population as intention-to-treat, per-protocol, or another formally defined analysis population. Nor does it report whether all enrolled participants were included, how protocol deviations were handled, or whether any sensitivity analyses were performed.

These omissions do not prove that the trial lacked prespecified procedures; they mean only that the procedures are not reported in the registry record. Without the analysis population rules, missing-data approach, and multiplicity plan, readers cannot fully assess how those choices may have affected the reported outcomes.

11. 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 0% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: dehydration (5.1%), diarrhea (3.4%), lymphocyte count decreased (3.4%), platelet count decreased (3.4%), febrile neutropenia (1.7%).

The registry’s safety summary lists 13 participants with serious adverse events among 59 at risk and 59 with other adverse events among 59 at risk. These are participant counts in the treatment group. They are not a comparison with an untreated group or another regimen. The record’s primary endpoint is narrower in scope: it specifies treatment-related events from treatment start through 90 days, using CTCAE version 3.0 and stated event criteria.

The listed serious-event terms and percentages are dehydration, 5.1%; diarrhea, 3.4%; lymphocyte count decreased, 3.4%; platelet count decreased, 3.4%; febrile neutropenia, 1.7%; and abdominal pain, 1.7%. The percentages should be read as the registry reports them. The information does not identify term-specific denominators or whether participants could contribute to more than one term.

General statistical explanation: a participant count is different from an event count. One participant may experience more than one event, while a participant-level measure generally counts that person once for the specified category. The registry’s summary reports affected participants, so it should not be interpreted as the total number of episodes. The record does not provide a detailed account of event duration, recurrence, or individual clinical course.

The difference between 60 enrolled and 59 at risk is not explained in the registry record. The safety figures describe the posted reporting population and should not be extended to participants not represented in that denominator.

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

The results describe safety events recorded in a single group of participants treated with bevacizumab, cisplatin, and radiation therapy. The registry reports 13 participants with serious adverse events among 59 at risk and 59 participants with other adverse events among 59 at risk. It also lists selected serious-event terms with percentages. These observations characterize the treatment group under the registry’s reporting definitions.

They do not establish that the regimen is safer or less safe than another treatment. There is no concurrent comparator, randomization, or between-group estimate in the design described. The counts also do not isolate the effects of bevacizumab from cisplatin or radiation. A reader should not treat an observed event in this setting as proof that a particular treatment component caused it; the registry’s event definitions and attribution are part of the reported outcome.

The primary endpoint focuses on treatment-related serious adverse events and adverse events within 90 days. It cannot describe events outside that period as part of the primary outcome. The broader safety summary lists serious and other adverse events, but the record details do not establish that every summary count uses exactly the same endpoint window and definition. The two presentations should be kept distinct unless more detailed reporting confirms their alignment.

The study lists disease-free survival and overall survival as secondary outcomes, with three-year rates reported, but numerical estimates for these outcomes are not included in the registry entries. No conclusion about survival outcomes can be drawn from their listing alone. Likewise, the safety counts do not answer the study’s efficacy question by themselves.

In general, statistical uncertainty matters when interpreting any estimate. The registry information does not give a confidence interval for the primary safety count, nor does it provide a detailed analysis plan. The size and precision of any treatment effect relative to a comparator therefore cannot be assessed from this record summary. The defensible reading is descriptive: the posted safety summary records these counts and terms among the participants in the treated group.

13. Why This Trial Matters Statistically

This trial is statistically informative as an example of the distinction between describing outcomes and estimating comparative effects. Its single-group design records events among treated participants, but it does not include a concurrent control group. The safety counts can therefore describe what was reported in this group without showing how those counts compare with outcomes under another regimen.

The endpoint also illustrates why outcome definitions matter. The primary measure is not simply every adverse event noted during care; it applies treatment-related criteria, CTCAE grading, and a defined period from treatment start to 90 days. These rules determine which participants count toward the endpoint. Clear definitions support interpretation, while missing details about event ascertainment and attribution limit how fully the results can be evaluated.

The record distinguishes enrollment from the population at risk in the safety summary: enrollment is 60, and the safety denominator is 59. That distinction is important in clinical-trial reporting because a count is meaningful only in relation to the people assessed. The record does not explain the denominator difference, making transparent population accounting a relevant limitation.

The trial also highlights that a planning illustration is not a report of observed power. The described sample-size assumptions use a hypothetical two-arm comparison, whereas the actual study is single-group. Those assumptions cannot be read as the design or analysis that generated the observed safety counts. The registry’s own sample-size justification is not reported.

More broadly, the record shows why readers should separate outcome listings from outcome estimates. Disease-free survival and overall survival are listed, but numerical results are not included in the details. An outcome name alone does not establish its observed value, uncertainty, or clinical meaning.

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 design limitation is the absence of a concurrent comparison group. The single-group study can report adverse events among participants receiving the treatment combination, but it cannot directly estimate a difference relative to another treatment or separate the effects of the regimen’s individual components. The registry also lists no masking, so the record does not describe blinded assessment.

There is a difference between the enrollment figure of 60 and the safety summary denominator of 59. The reason is not reported in the registry record. The primary endpoint population is described as eligible participants who began treatment, but the record details do not explain whether this population matches the safety summary population in every respect.

The registry defines the primary safety endpoint and lists leading serious adverse-event terms, but the information does not give a confidence interval, detailed event-level data, or term-specific denominators. It also does not state how incomplete outcome information was handled, how events were attributed, or whether event assessment was independently reviewed. The statistical analysis plan and sample-size justification are not reported in the registry record.

The treatment-arm description is incomplete in the registry text available for some brachytherapy details. The listed secondary outcomes include disease-free survival and overall survival with three-year rates reported, but numerical estimates are not included in the information. These gaps limit assessment of the full treatment schedule, longer-term outcomes, and the precision of reported effects.

Finally, the described sample-size planning assumptions concern an illustrative two-arm design and should not be mistaken for the actual single-group trial’s design rationale. The registry does not report interim analyses or a multiplicity plan. These limitations constrain interpretation of both the safety counts and any broader conclusions about treatment effects.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Bevacizumab, Radiation Therapy, and Cisplatin in Treating Patients With Previously Untreated Locally Advanced Cervical Cancer — NCT00369122.
• Registry record last updated 2018-03-20; status last verified 2018-02.
• Results first posted 2013-05-17.
• 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.

18. Record Summary

NCT00369122 is a completed phase II, single-group study sponsored by the National Cancer Institute. The registry lists enrollment of 60, no masking, and a study start date of 2006-08-11 with primary completion on 2010-06-04. The treatment group received bevacizumab, cisplatin, and radiation therapy for previously untreated locally advanced cervical cancer.

The primary endpoint counts eligible participants who began treatment and had treatment-related serious adverse events or adverse events, assessed using CTCAE version 3.0 from treatment start to 90 days. The safety summary lists 13 participants with serious adverse events among 59 at risk and 59 with other adverse events among 59 at risk. The registry also lists disease-free and overall survival as secondary outcomes, with three-year rates reported.

Because the study has no comparator group, its safety findings are descriptive rather than comparative. The registry record does not report the reason for the difference between enrollment and the safety denominator, numerical survival estimates in the details, or the full statistical analysis plan.