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 Broccoli Sprout Extract in Treating Patients With Transitional Cell Bladder Cancer Undergoing Surgery (NCT01108003), a randomized na study. The primary outcome is Toxicity as Assessed by National Cancer Institute (NCI) Common Toxicity Criteria Version 3.0.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01108003 |
| Phase | NA |
| Condition | Recurrent Bladder Cancer, Stage 0 Bladder Cancer, Stage I Bladder Cancer |
| Allocation | Randomized |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 7 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Roswell Park Cancer Institute |
| Results posted | Yes |
2. Clinical Question
Population
Patients with superficial or locally advanced bladder cancer undergoing surgery were the intended population. The registry lists recurrent bladder cancer, Stage 0 bladder cancer, Stage I bladder cancer, Stage II bladder cancer, and transitional cell carcinoma of the bladder among the conditions. The primary outcome population is described as all treated and eligible patients. Eligibility criteria beyond these descriptions are not reported in the registry record.
Intervention
Arm I received oral broccoli sprout extract once daily on days 1-14, in the absence of disease progression or unacceptable toxicity. The registry describes the study as a pilot focused on the side effects of the extract in patients undergoing surgery. Laboratory biomarker analysis is also listed as an intervention, but further details about its role are not reported in the registry record.
Comparator
Arm 2 received mango juice alone. The record lists randomized allocation and describes this arm, but does not report details of the randomization process, allocation concealment, or any masking. The masking field says none.
Primary question
The primary outcome asks how many participants had an adverse event during the stated 14 days, using National Cancer Institute Common Toxicity Criteria Version 3.0. The registry presents toxicity counts by arm. It does not provide an estimable statistical comparison between the arms, so the posted results do not establish a comparative effect of broccoli sprout extract on toxicity.
3. Trial Design
This was a pilot pre-cystectomy study of broccoli sprout extract in patients with superficial or locally advanced bladder cancer. The registry lists Roswell Park Cancer Institute as the sponsor, gives a start date of 2010-04, and records primary completion in 2014-09. The trial status is terminated. A reason for termination is not reported in the registry record.
The registry describes allocation as randomized and masking as none. It lists Arm I, which received oral broccoli sprout extract once daily on days 1-14 in the absence of disease progression or unacceptable toxicity, and Arm 2, which received mango juice alone. Enrollment is recorded as 7. The arm-level outcome entries list 4 participants in Arm I and 3 in Arm 2. The model classification is single group, although the record also lists two arms and randomized allocation. The record does not explain this combination of design fields, so the exact intended analysis structure is unclear.
The stated purpose was to study side effects in patients undergoing surgery. The primary endpoint is toxicity, assessed using National Cancer Institute Common Toxicity Criteria Version 3.0, with a timeframe of 14 days. Secondary outcomes include apoptosis, cell proliferation, and microvessel density. Laboratory biomarker analysis is listed, but details of the procedures and their timing are not reported in the registry record.
The registry does not report the randomization sequence, allocation concealment, eligibility criteria in detail, or a statistical analysis plan. It also does not describe any interim analyses or sample-size justification. Those omissions limit how fully the study design and intended interpretation can be reconstructed from the 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
| Stage | Arm I | Arm 2 |
|---|---|---|
| STARTED | 4 | 3 |
| COMPLETED | 4 | 3 |
| NOT COMPLETED | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: All treated and eligible patients.
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: All treated and eligible patients
| Characteristic | Unit | Arm I | Arm 2 | Total |
|---|---|---|---|---|
| Participants analysed | 4 | 3 | 7 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 | 0 | 0 |
| Age, Categorical: >=65 years | Participants | 4 | 3 | 7 |
| Age, Continuous | years | 74 (SD 5.3) | 73 (SD 4.9) | 74 (SD 4.7) |
| Sex: Female, Male: Female | Participants | 1 | 0 | 1 |
| Sex: Female, Male: Male | Participants | 3 | 3 | 6 |
6. Primary Endpoint
The registry lists the primary outcome as Toxicity as Assessed by National Cancer Institute (NCI) Common Toxicity Criteria Version 3.0, measured over 14 days.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants with an adverse event, assessed using National Cancer Institute Common Toxicity Criteria Version 3.0 over 14 days. The registry identifies the outcome unit as participants and describes the population as all treated and eligible patients. The posted arm-level values are counts: 4 participants in Arm I and 3 in Arm 2.
A count of participants with an event is a binary-outcome summary at the participant level: each person is classified according to whether an event was recorded during the stated observation period. This type of endpoint is useful in a pilot safety study because it can describe how many participants experienced an adverse event under the study conditions. General statistical context: event counts alone do not describe the event’s severity, duration, relationship to treatment, or clinical course unless those features are separately reported.
The record does not report a detailed definition of which adverse events qualify for the primary endpoint, how events were attributed, or whether the outcome includes all grades of toxicity. It also does not give a comparative estimate or uncertainty interval for the difference between arms. The stated endpoint therefore supports a descriptive reading of the posted counts, not a precise comparative conclusion.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The primary outcome entries report 4 participants with an adverse event in Arm I and 3 in Arm 2. These are counts, not comparative effect estimates. The record does not provide an inferential analysis for the binary endpoint; it explicitly indicates that values are missing or not estimable for a two-arm comparison. As a result, there is no posted estimate of the difference between arms, no confidence interval for that difference, and no reported p-value for the primary comparison.
The counts should be read in the context of the small arm-level records: the outcome entry lists 4 participants in Arm I and 3 in Arm 2. Each count is close to the corresponding number listed in the arm-level outcome entry, but this descriptive observation does not resolve the absence of a comparative analysis. With a small amount of information, the observed counts cannot by themselves establish whether any apparent difference reflects a treatment effect, chance variation, or other features of the study.
The primary outcome is described as the number of participants with an adverse event over 14 days. It is not a measure of the total number of events, the frequency of repeated events, or their severity. Further detail on the primary outcome’s event definitions and grading is not reported in the registry record. The broader adverse-event summary separately reports serious and other adverse-event counts, and these should not be treated as interchangeable with the primary endpoint without a definition linking them.
The registry lists serious adverse event counts of 2 affected among 4 at risk in Arm I and 1 affected among 3 at risk in Arm 2. It also lists other adverse event counts of 4 affected among 4 at risk in Arm I and 3 affected among 3 at risk in Arm 2. These figures are descriptive summaries. No comparative statistical analysis of these safety counts is reported, and the record does not provide uncertainty estimates for them.
The record lists the trial as terminated, but the reason is not reported in the registry record. Termination alone does not explain why the study ended or how it affected the completeness of follow-up and outcome reporting. The registry does not provide enough information to determine whether all planned assessments were completed. The posted values should therefore be interpreted as the available registry summaries, rather than as evidence that all intended analyses were completed.
Planning illustrations based on an observed effect, when used, are not observed power and do not add evidence about the treatment comparison. The registry’s own analysis would take precedence if a discrepancy were reported; no discrepancy is indicated in this record. Since a comparative estimate is not available, the observed counts cannot support a conclusion about the relative safety of the two arms.
9. Statistical Methods Explained
The primary endpoint is a participant-level count of adverse events. For a binary outcome, each participant contributes to an event category according to whether the outcome occurred during the stated timeframe. General statistical context: this makes the endpoint different from a count of all event episodes, because a participant with repeated events may still contribute only once to a participant-level event count. The registry describes the outcome as the number of participants with an adverse event and sets the timeframe at 14 days.
What can an event count show?
An event count describes the observed experience in the recorded population. It is useful as a direct summary, but it does not by itself quantify how uncertain the result is or separate a treatment-related effect from other explanations. A comparative analysis would normally estimate how the event occurrence differs between arms and describe the uncertainty around that estimate. The registry does not report such an estimate for the primary binary endpoint. It states that values are missing or not estimable for a two-arm comparison.
That absence matters for interpretation. The listed arm counts can be read as descriptive results, but the record does not support a statistical comparison of them. It would be inappropriate to infer a p-value, confidence interval, or adjusted effect from the counts. No calculation of those quantities is reported in the registry record, and no alternative inferential method is identified.
What does a confidence interval mean?
General statistical context: a confidence interval is a range produced by a statistical method to express the precision of an estimated effect. A narrow interval indicates greater precision under that method’s assumptions; a wide interval indicates less precision. The interval is not a guarantee that the true effect lies within its endpoints. In this record, no comparative confidence interval is reported, so the precision of a between-arm effect cannot be assessed from the posted primary outcome.
Similarly, a p-value would address how compatible the observed data are with a specified statistical model and null hypothesis. It would not measure the probability that a treatment works, nor would it describe the size or practical importance of an effect. No primary comparison p-value is reported. The lack of a p-value is not evidence of equivalence or of no difference; it means the registry does not provide that inferential result.
Why does the analysis population matter?
The primary outcome description names all treated and eligible patients as the population. However, the registry does not report a fuller definition of this population, such as how eligibility was determined for the analysis or how participants with incomplete observations were handled. The arm-level outcome entries list 4 participants for Arm I and 3 for Arm 2. No account of exclusions or withdrawals is reported in the registry record. Without those details, the relation between enrollment, treatment exposure, eligibility, and outcome availability cannot be fully evaluated.
The record lists randomized allocation, but does not report the randomization method, allocation concealment, or a statistical model. It also classifies the model as single group while listing Arm I and Arm 2. The record does not explain this design-field combination. Therefore, the intended basis for a comparative analysis is not clear from the registry description, beyond the presence of arm-specific entries.
What can planning calculations tell readers?
General statistical context: sample-size planning uses assumptions about the effect to be detected, the chosen significance level, allocation, and statistical method. The registry describes planning illustrations based on the observed effect, a two-sided significance level of 0.05, equal allocation, and a normal approximation. Such illustrations are hypothetical planning exercises. They are not observed power, do not replace an analysis of the trial data, and should not be read as a result of the study. The actual design justification and its assumptions are not reported in the registry record.
For binary outcomes, methods can differ in how they model event probabilities and account for small samples. General statistical context: a normal approximation can be less dependable when the amount of information is limited or event patterns are sparse. Other approaches may be considered in an analysis plan, but the registry does not report a selected method for this endpoint. No method should be attributed to the investigators without that information.
Over-dispersion is a general concern when observed variability exceeds what a model assumes. It is more directly relevant to outcomes represented by counts with variability beyond a simple count model’s assumptions than to the posted participant-level binary summary. The record does not report an over-dispersion assessment or a model requiring such an adjustment. Accordingly, it is not possible to say that over-dispersion was tested or addressed.
The registry lists one secondary outcome entry among the posted secondary outcomes and gives apoptosis, cell proliferation, and microvessel density as secondary outcomes. It records zero analyses. Outcome descriptions, numerical secondary results, and methods for analysing those measures are not reported in the registry record. The available information therefore supports a narrow description of the toxicity counts, rather than a reconstruction of a complete statistical analysis.
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.
| Arm | Participants | Events | Observed % | Clopper-Pearson 95% CI | Wilson 95% CI | Bayesian 95% credible interval |
|---|---|---|---|---|---|---|
| Arm I | 4 | 4 | 100.0% | 39.8% to 100.0% | 51.0% to 100.0% | 47.8% to 99.5% |
| Arm 2 | 3 | 3 | 100.0% | 29.2% to 100.0% | 43.9% to 100.0% | 39.8% to 99.4% |
R code and output
arm <- c("Arm I", "Arm 2")
n <- c(4, 3)
events <- c(4, 3)
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 Arm I 4 4 100.0 39.8 100.0 51.0 100.0 47.8 99.5
ARM Arm 2 3 3 100.0 29.2 100.0 43.9 100.0 39.8 99.411. Multiplicity, Missing Data and Analysis Populations
The registry lists apoptosis, cell proliferation, and microvessel density as secondary outcomes. It records one posted secondary outcome entry and zero analyses. Numerical results for the secondary outcomes and a plan for interpreting multiple outcomes are not reported in the registry record. No multiplicity adjustment is reported. General statistical context: when several outcomes or comparisons are examined, the chance of a false-positive finding can increase if each is interpreted separately without an appropriate plan. The record does not say whether multiplicity was addressed in the study’s analysis.
Missing-data procedures are not reported in the registry record. The record does not state whether any participants lacked primary outcome data, how such data were handled, or whether follow-up was complete. Trial status is terminated, but this status alone does not establish that outcome data are missing or explain the reason for termination. The reason for termination is not reported in the registry record.
The primary outcome population is described as all treated and eligible patients. The record does not provide a fuller analysis-population definition or explain how eligibility, treatment exposure, or incomplete observations affected inclusion. It also does not report an intention-to-treat analysis or another named analysis population. Thus, the available information does not allow readers to determine whether the primary results include every randomized participant or only participants meeting particular post-randomization conditions.
These omissions limit the ability to assess whether outcome reporting was complete and how robust the results are to missing information or analytic choices. The posted counts remain descriptive, and no unreported missing-data or multiplicity method should be assumed.
12. 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 |
|---|---|---|---|
| Arm I | 2 | 4 | 50.0% |
| Arm 2 | 1 | 3 | 33.3% |
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 |
|---|---|
| Arm I | 4 of 4 |
| Arm 2 | 3 of 3 |
Most frequent serious adverse event terms
| Event term | Organ system | Arm I | Arm 2 |
|---|---|---|---|
| Fungaemia | Infections and infestations | 1 of 4 | 0 of 3 |
| Sepsis | Infections and infestations | 0 of 4 | 1 of 3 |
| Urosepsis | Infections and infestations | 1 of 4 | 0 of 3 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Arm I | Arm 2 |
|---|---|---|---|
| Hyperglycaemia | Metabolism and nutrition disorders | 3 of 4 | 3 of 3 |
| Lymphocyte count decreased | Investigations | 2 of 4 | 3 of 3 |
| Anaemia | Blood and lymphatic system disorders | 2 of 4 | 2 of 3 |
| Constipation | Gastrointestinal disorders | 2 of 4 | 2 of 3 |
| Hypocalcaemia | Metabolism and nutrition disorders | 1 of 4 | 3 of 3 |
| Hyponatraemia | Metabolism and nutrition disorders | 1 of 4 | 3 of 3 |
| Pain | General disorders | 3 of 4 | 0 of 3 |
| Nausea | Gastrointestinal disorders | 2 of 4 | 0 of 3 |
| Blood albumin decreased | Investigations | 1 of 4 | 1 of 3 |
| Blood creatinine increased | Investigations | 1 of 4 | 1 of 3 |
Serious events with the highest arm-level rate: sepsis (33.3%), fungaemia (25.0%), urosepsis (25.0%).
The safety summary lists serious adverse events for Arm I as 2 participants affected among 4 at risk, and for Arm 2 as 1 affected among 3 at risk. For other adverse events, it lists 4 affected among 4 at risk in Arm I and 3 affected among 3 at risk in Arm 2. These are registry counts, not comparative estimates. The record does not report uncertainty intervals or a statistical comparison for these summaries.
The registry also lists Sepsis at 33.3%, Fungaemia at 25.0%, and Urosepsis at 25.0% among the top serious adverse event terms. The denominator and precise context for these percentages are not reported in the registry record. The listed terms should not be added together or interpreted as mutually exclusive categories; the record does not specify how the terms relate to affected participants or to one another.
General statistical context: safety counts can be difficult to compare when the number of participants at risk is small, and a count does not convey the full clinical course or severity of an event. The record does not report event-level timing, duration, attribution, or detailed grading. These summaries therefore describe what was posted, without establishing the comparative safety profile of the arms.
13. What the Result Does, and Does Not, Mean
The posted primary result is a count of participants with an adverse event during the stated 14-day timeframe: 4 in Arm I and 3 in Arm 2. The registry also reports serious and other adverse-event counts by arm. These summaries describe the observed entries in this terminated pilot study. They do not provide an estimable statistical comparison between broccoli sprout extract and mango juice alone.
The results do not establish whether the arms differed in toxicity, how large any difference might be, or how precisely a difference could be estimated. The registry does not report a comparative effect estimate, confidence interval, or p-value for the primary outcome. The absence of those results should not be read as proof that the arms were equivalent or that there was no difference.
The primary endpoint concerns whether a participant had an adverse event, not the total number of events or a complete account of severity and clinical course. Separate serious and other adverse-event counts provide additional descriptive safety information, but their definitions and relationship to the primary outcome are not fully specified in the record. The serious-event term percentages also lack a reported denominator and context.
The study’s stated purpose was to study side effects in patients with bladder cancer undergoing surgery. The record does not report results that establish an effect on cancer outcomes, nor does it provide complete numerical findings for the listed secondary biomarker outcomes. No conclusion about prevention or slowing of cancer growth can be drawn from the toxicity counts.
General statistical context: a pilot study can help characterize feasibility or generate information for further study, but its observed counts are not by themselves definitive evidence of a treatment effect. Here, the design details, analysis plan, missing-data handling, and reason for termination are not reported in the registry record. Those limitations make a cautious, descriptive interpretation appropriate.
14. Why This Trial Matters Statistically
This record illustrates why a clinical result needs both an observed outcome and a clearly reported analysis. Counts of participants with adverse events are straightforward to describe, but an arm-to-arm interpretation also depends on an estimable comparison and information about its precision. The registry presents arm-specific toxicity counts while indicating that a two-arm binary comparison is not estimable. Readers therefore have descriptive results but no reported estimate of the comparative effect.
The endpoint and timeframe are clearly named: toxicity assessed using National Cancer Institute Common Toxicity Criteria Version 3.0 over 14 days. At the same time, the record does not fully define the event criteria, explain the analysis population, or report how incomplete outcome information was handled. Those details affect what a count represents and how confidently it can be interpreted.
The design fields also show why registry descriptions need to be read together. Allocation is listed as randomized, the model classification is single group, and the record names Arm I and Arm 2. The record does not explain this combination. It also lists secondary biomarker outcomes but reports zero analyses. The gap between stated outcomes and posted analyses limits what can be learned from the record about the broader scientific questions.
Finally, a terminated status is not an explanation of why a study ended. The reason is not reported in the registry record, and the status does not establish whether planned assessments were completed. Transparent reporting of design, outcome definitions, analysis populations, and reasons for incomplete reporting is important for interpreting pilot-study evidence. In this case, the statistical value lies primarily in identifying what the posted safety summaries do and do not support.
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.
The registry’s design description is incomplete for reconstructing the intended comparison. It lists randomized allocation and two arms, but classifies the model as single group. The record does not explain this combination or describe the randomization process, allocation concealment, or a statistical analysis plan. Masking is listed as none.
The primary result is reported as counts, and the registry states that values are missing or not estimable for a two-arm comparison. No comparative estimate, confidence interval, or p-value is reported. The counts are therefore descriptive rather than evidence of a quantified between-arm effect. The enrollment entry is 7, and the arm-level outcome entries list 4 participants for Arm I and 3 for Arm 2; the record does not explain the relation between enrollment and analysis eligibility in detail.
The primary outcome is described as participants with an adverse event over 14 days, but detailed event definitions, grading information, and event attribution procedures are not reported in the registry record. The serious adverse event term percentages are listed without a reported denominator or further context. The record also does not describe missing-data handling, withdrawals, or the completeness of follow-up.
The trial is terminated, but the reason is not reported in the registry record. The registry lists secondary outcomes, but detailed numerical results and methods for analysing them are not reported; it records zero analyses. A sample-size justification, interim analyses, and the investigators’ statistical plan are also not reported in the registry record. These limitations restrict interpretation to the posted descriptive safety summaries and prevent a fuller assessment of comparative effects or reporting completeness.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Broccoli Sprout Extract in Treating Patients With Transitional Cell Bladder Cancer Undergoing Surgery — NCT01108003.
- Registry record last updated 2017-06-26; status last verified 2017-05.
- Results first posted 2016-06-23.
- 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.
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19. Record Summary
NCT01108003 is a pilot pre-cystectomy trial of broccoli sprout extract in patients with superficial or locally advanced bladder cancer. The registry lists randomized allocation, no masking, a single-group model classification, and two arms: broccoli sprout extract and mango juice alone. Enrollment is recorded as 7, and trial status is terminated. The reason for termination is not reported in the registry record.
The primary endpoint is the number of participants with an adverse event, assessed using National Cancer Institute Common Toxicity Criteria Version 3.0 over 14 days. The posted counts are 4 in Arm I and 3 in Arm 2. Serious and other adverse-event counts are also listed. A two-arm comparison is not estimable in the posted results, and no comparative estimate or uncertainty interval is reported.
Secondary outcomes include apoptosis, cell proliferation, and microvessel density. The registry records zero analyses. Details of the statistical plan, missing-data handling, and sample-size justification are not reported in the registry record.