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 Chemotherapy and Radiation Therapy (RT) With or Without Vandetanib in Treating Patients With High-Risk Stage III or Stage IV Head and Neck Cancer (NCT00720083), a randomized phase 2 study. The primary outcome is Disease-free Survival.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00720083 |
| Phase | Phase 2 |
| Condition | Head and Neck Cancer |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 34 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Radiation Therapy Oncology Group |
| Results posted | Yes |
2. Clinical Question
Population
Patients with high-risk postoperative advanced squamous cell carcinoma of the head and neck. The brief description identifies high-risk stage III or stage IV head and neck cancer. The condition listed in the record is head and neck cancer.
Intervention
Radiation therapy and cisplatin, with vandetanib added. The treatment description says vandetanib was taken orally once daily beginning 14 days before radiotherapy. The record describes cisplatin and radiotherapy schedules for this arm, but its description of treatment duration ends before giving a complete account of that arm.
Comparator
Radiation therapy with cisplatin, without vandetanib. The record describes radiotherapy five times a week for up to 6.5 weeks and cisplatin on days 1, 22, and 43 of radiotherapy. Treatment was described as continuing for 6 weeks in the absence of disease progression or unacceptable toxicity.
Primary question
The trial was designed to compare disease-free survival between the two treatment strategies. Disease-free survival was defined from randomization to local, regional, or distant progression, or death, with last follow-up also specified in the timeframe. The registry record states that the trial terminated early and no analyses were performed, so it does not provide a comparative answer to this question.
This was a randomized phase II trial with a parallel-arm design and no masking. Its stated purpose was to assess chemoradiotherapy with and without vandetanib in patients with high-risk stage III or stage IV head and neck cancer after surgery. The population description in the official title is more specific, referring to postoperative advanced squamous cell carcinoma of the head and neck.
The clinical question is therefore a comparison of treatment strategies, not an estimate of the effect of vandetanib in isolation. Both arms included radiation therapy and cisplatin; the additional planned treatment in one arm was vandetanib. However, the registry record does not report a completed comparative analysis of disease-free survival. It also does not provide an estimate of the difference between the groups, a confidence interval, or a test of the primary outcome. The question was posed by the trial design, but the posted record does not resolve it.
3. Trial Design
The registry record describes a randomized phase II, parallel-group study with no masking. The sponsor was the Radiation Therapy Oncology Group. The trial began in 2008-11, had a primary completion date of 2011-08, and is listed as terminated. Enrollment was 34, while the primary outcome description says that 170 participants had been planned. The record does not explain the reason for termination or give the planned-versus-observed accrual by arm.
The two groups were radiation therapy plus cisplatin, and radiation therapy plus cisplatin and vandetanib. In the first group, radiotherapy was scheduled five times a week for up to 6.5 weeks, with cisplatin on days 1, 22, and 43 of radiotherapy. The second group was described as receiving radiotherapy as in the first group, weekly cisplatin beginning on day 1 of radiotherapy, and daily oral vandetanib beginning 14 days before radiotherapy. The treatment description for the second group is incomplete in the registry record, so the full schedule and duration cannot be reconstructed from that description.
Although randomization is specified, the method used to generate the allocation sequence, any allocation concealment procedures, and any stratification factors are not reported in the registry record. Masking is explicitly listed as none. The record does not give the number randomized to each arm as a design result, nor does it describe whether participants could switch treatments or how adherence was assessed.
The primary outcome was disease-free survival. Its timeframe was from randomization to failure, defined as local, regional, or distant progression, or death, or to last follow-up. The record says the analysis was to occur after 78 failures had been reported. It also states that the study terminated early with 34 subjects accrued out of 170 planned and that no analyses were performed. Thus, the planned event-based analysis is described, but no completed primary outcome comparison is posted.
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: 34 subjects were registered, after which 2 did not continue to randomization due to physician preference.
Overall Study
| Stage | RT + Cisplatin | RT + Cisplatin + Vandetanib |
|---|---|---|
| STARTED | 17 | 15 |
| COMPLETED | 16 | 13 |
| NOT COMPLETED | 1 | 2 |
Reasons for not completing this period:
| Reason | RT + Cisplatin | RT + Cisplatin + Vandetanib |
|---|---|---|
| Ineligible | 1 | 2 |
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 eligible patients.
| Characteristic | Unit | RT + Cisplatin | RT + Cisplatin + Vandetanib | Total |
|---|---|---|---|---|
| Participants analysed | 16 | 13 | 29 | |
| Age, Continuous | years | 57 (40 to 74) | 53 (39 to 76) | 57 (39 to 76) |
| Sex: Female, Male: Female | Participants | 3 | 3 | 6 |
| Sex: Female, Male: Male | Participants | 13 | 10 | 23 |
6. Primary Endpoint
The registry lists the primary outcome as Disease-free Survival, measured over From randomization to date of failure (local, regional, or distant progression, or death) or last follow-up. Analysis occurs after 78 failures have been reported..
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
Disease-free survival was the primary endpoint. In the registry record, it is timed from randomization until a failure event or last follow-up. Failure was defined as local progression, regional progression, distant progression, or death. A time-to-event endpoint uses both whether an event occurs and how long participants remain free of that event during follow-up. It can therefore describe the timing of failures, rather than only classifying participants as having or not having an event at a fixed visit.
In general, disease-free survival is used to summarize how long participants remain without specified disease-related events after entering the study. The exact event definition matters: including different kinds of progression and death means that each can count as an endpoint event under the stated definition. The registry record does not provide separate results for those event types, and no endpoint analysis was performed according to the posted description.
The planned timing of analysis was after 78 failures had been reported. That is a stated analysis trigger, not evidence that 78 failures occurred. The record says the study terminated with 34 participants accrued and that no analyses were performed. It does not report the number of observed failures, follow-up duration, censoring distribution, or an estimated disease-free survival curve. Consequently, the endpoint definition and planned analysis timing are available, but the observed primary outcome results are not.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central interpretive fact is that the registry record reports no analyses of the primary endpoint. The study was terminated after 34 participants were accrued out of 170 planned, and the outcome description explicitly says that no analyses were performed. The record therefore provides no comparative estimate of disease-free survival for radiation therapy and cisplatin versus the same treatment combination with vandetanib.
There is no posted hazard ratio, survival probability, median disease-free survival, confidence interval, or primary-outcome test result. These are not values that can be inferred from the trial title, treatment descriptions, enrollment, or safety entries. Nor can a conclusion about the relative outcome of the arms be drawn from the fact that the study was randomized: randomization describes the intended assignment design, while an outcome estimate requires analyzable follow-up data and a reported analysis.
The record says the planned analysis was to take place after 78 failures. It does not say how many failures had occurred when the trial terminated. It would therefore be incorrect to treat the planned event threshold as an observed event count or to infer how close the study came to that threshold. The trial's early termination and limited accrual also mean that its planned comparison was not completed as described in the posted record. The reason for termination is not reported in the registry record.
The adverse-event section does contain counts for serious and other adverse events by group, as well as a list of serious event terms with percentages. Those entries describe safety reporting, not disease-free survival. They cannot stand in for the primary endpoint, and they do not establish whether one treatment strategy had a more favorable overall benefit-risk profile. The record does not provide enough context about adverse-event definitions, observation windows, or the allocation of the listed terms to groups to make a broad comparative safety interpretation.
Any sample-size material elsewhere on the page should be read as a planning illustration based on an observed effect only where such an effect is available. Here, the primary analysis is absent, so the record does not provide a primary-outcome effect to interpret. Planning scenarios are not observed trial results and are not evidence that the trial had a particular probability of detecting an effect. The analysis information needed to support a comparative inference is not reported in the registry record.
In general, a confidence interval communicates the range of effect values reasonably compatible with the data and analysis, subject to the method's assumptions. No such interval is posted for the primary endpoint. The absence of an estimate and interval means there is no basis in this record to judge the precision of a disease-free survival comparison. It should be described as an unreported analysis, rather than as evidence of equivalence, no difference, or a null effect.
9. Statistical Methods Explained
The following statistical concepts are general explanations of how a trial of this kind may be analyzed; they are not a description of methods confirmed for this trial unless explicitly stated in the registry record. The record identifies randomization, a parallel design, no masking, a disease-free survival endpoint, and a planned analysis after 78 failures. It does not provide a full statistical analysis plan.
Why randomization matters
In general, randomization assigns participants to groups using a chance-based process. Its purpose is to reduce systematic differences in baseline characteristics between treatment groups, so that a comparison can be interpreted more fairly. Randomization does not guarantee that every characteristic will be balanced in a small study, and it does not by itself ensure that a valid result can be estimated. The sequence-generation method, allocation concealment, and any stratification procedures are not reported in the registry record. The record does identify the study as randomized, but the absence of these details limits assessment of how assignment was implemented.
A parallel design means the trial compares groups assigned to different strategies over the course of the study, rather than having each participant receive both strategies in sequence. Here, the strategies share radiation therapy and cisplatin, while vandetanib is added in one arm. Because the record reports no primary analysis, the intended randomized comparison cannot be translated into an estimated treatment contrast.
How a time-to-event endpoint is usually analyzed
In general, time-to-event methods account for the time from a defined starting point to an event. Participants who have not had an event by the end of their observed follow-up may contribute information up to that point without being treated as if an event occurred. This is commonly called censoring. The disease-free survival timeframe begins at randomization and ends at specified progression, death, or last follow-up. The registry record does not state how censoring was handled, how follow-up was summarized, or which model or statistical test was planned.
A survival curve is one common way to display the estimated probability of remaining free of the defined event over time. A comparison may also be summarized by a relative measure such as a hazard ratio, with a confidence interval, if those methods are prespecified and appropriate. These are general examples only: no survival curve, hazard ratio, confidence interval, or test result for disease-free survival is posted in this record. The planned analysis after 78 failures is not itself a result or a statistical method specification.
The event definition determines what the endpoint means. Here, local, regional, or distant progression and death were all included as failures. If the event types have different clinical or statistical patterns, a composite endpoint can summarize them together, but it does not show their separate contributions unless those are also reported. Separate event-type results are not reported in the registry record.
Event-driven analysis timing
In general, an event-driven analysis is scheduled according to the number of outcome events rather than solely by a calendar date. Event counts can determine how much information is available for a time-to-event comparison. This trial record states that analysis would occur after 78 failures had been reported. It does not state that this count was reached. The record instead says the trial terminated early after 34 participants were accrued and that no analyses were performed. The actual failure count and any changes to the planned trigger are not reported in the registry record.
The record does not state whether interim analyses were planned or conducted, whether any stopping boundaries were specified, or whether the primary analysis timing changed. It would be inappropriate to infer these aspects from the stated event trigger alone. A stated endpoint threshold does not establish the existence of interim monitoring, nor does early termination establish why the study stopped.
Precision and confidence intervals
In general, an estimate describes the effect observed in a study, while a confidence interval describes its statistical uncertainty under the chosen method. A narrower interval indicates greater precision than a wider interval, though interpretation still depends on the analysis and design. When few participants or events contribute information, estimates can be imprecise; the degree of precision, however, must be assessed from actual results and cannot be calculated from enrollment alone. No primary-outcome estimate or interval is posted.
A p-value, when reported, summarizes how unusual data at least as incompatible with a specified null hypothesis would be under the test assumptions. It does not give the probability that a treatment works, nor does it measure the size or clinical importance of an effect. The registry record provides no primary-outcome p-value. It is not possible to characterize the statistical evidence for a difference from the posted information.
Over-dispersion and model assumptions
In general, over-dispersion occurs when observed variability is greater than a statistical model expects. If it is ignored in a setting where it is present, standard errors and uncertainty estimates can be misleading. The relevance of over-dispersion depends on the outcome and model; it is not automatically an issue in every trial analysis. The registry record does not identify a model for the primary endpoint or report any assessment of over-dispersion. No claim about whether it was present or addressed can be made for this study.
Other assumptions can matter for time-to-event comparisons, including how event times and censoring are handled and whether the selected model is suitable for the data. These are general considerations, not trial-specific findings. The full statistical methods and diagnostics are not reported in the registry record, and the absence of a completed primary analysis means there are no posted model results to examine.
Planning calculations are not trial results
In general, sample-size planning calculations depend on a target effect, variability or event assumptions, the significance level, allocation, and desired power. The planning section is described as an illustration based on an observed effect, using a two-sided significance level of 0.05, equal allocation, and a normal approximation; for time-to-event tables it expresses total events, while other tables express participants per arm. Such illustrations are not observed power and are not a substitute for the trial's design rationale. The record does not report the original sample-size justification, the assumptions used to plan for 170 participants, or a completed primary effect estimate. Any scenario should therefore be read only as a planning illustration, not evidence of what the study demonstrated.
10. Multiplicity, Missing Data and Analysis Populations
Multiplicity arises when a study tests multiple outcomes, time points, groups, or hypotheses. In general, the more statistical comparisons made, the greater the chance that at least one result may appear noteworthy by chance if no adjustment or prespecified hierarchy is used. A statistical plan can address this by defining a primary endpoint, controlling the overall error rate, or specifying how secondary results will be interpreted.
The registry record identifies disease-free survival as the primary outcome and specifies a planned analysis after 78 failures. It does not describe a multiplicity strategy, a hierarchy among secondary outcomes, or any adjustment for multiple comparisons. The number of outcome measures listed is one, but that alone does not establish that only one statistical test was planned or that there were no additional analyses. The broader analysis plan is not reported in the registry record.
Missing data and analysis populations are also not described in sufficient detail. The record does not state which participants would be included in the primary analysis, how participants with missing follow-up would be handled, or whether analyses would follow the randomized assignment regardless of treatment received. It does not report treatment discontinuation, crossover, adherence, or the amount and pattern of missing outcome data. Last follow-up is included in the endpoint timeframe, but this does not explain the censoring rules or missing-data procedures.
These omissions matter because analysis choices can affect the population represented by an estimate and the uncertainty around it. In this case, no primary analysis was performed according to the record, so there is no reported population-specific estimate to assess. Details of multiplicity control, missing-data handling, and analysis populations are not reported in the registry record; they should not be inferred from the randomized design or endpoint definition.
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 |
|---|---|---|---|
| RT+ Cisplatin | 6 | 16 | 37.5% |
| RT + Cisplatin + Vandetanib | 4 | 13 | 30.8% |
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 |
|---|---|
| RT+ Cisplatin | 16 of 16 |
| RT + Cisplatin + Vandetanib | 12 of 13 |
Most frequent serious adverse event terms
| Event term | Organ system | RT+ Cisplatin | RT + Cisplatin + Vandetanib |
|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | 2 of 16 | 0 of 13 |
| Dysphagia | Gastrointestinal disorders | 2 of 16 | 0 of 13 |
| Mucositis oral | Gastrointestinal disorders | 2 of 16 | 0 of 13 |
| Infections and infestations - Other | Infections and infestations | 1 of 16 | 1 of 13 |
| Neutrophil count decreased | Investigations | 2 of 16 | 0 of 13 |
| Anorexia | Metabolism and nutrition disorders | 2 of 16 | 0 of 13 |
| Dehydration | Metabolism and nutrition disorders | 2 of 16 | 0 of 13 |
| Abdominal pain | Gastrointestinal disorders | 1 of 16 | 0 of 13 |
| Dry mouth | Gastrointestinal disorders | 1 of 16 | 0 of 13 |
| Nausea | Gastrointestinal disorders | 1 of 16 | 0 of 13 |
Most frequent non-serious adverse event terms
| Event term | Organ system | RT+ Cisplatin | RT + Cisplatin + Vandetanib |
|---|---|---|---|
| Dysphagia | Gastrointestinal disorders | 13 of 16 | 11 of 13 |
| Dry mouth | Gastrointestinal disorders | 13 of 16 | 10 of 13 |
| Mucositis oral | Gastrointestinal disorders | 13 of 16 | 10 of 13 |
| Dermatitis radiation | Injury, poisoning and procedural complications | 12 of 16 | 7 of 13 |
| Nausea | Gastrointestinal disorders | 12 of 16 | 6 of 13 |
| Fatigue | General disorders | 12 of 16 | 5 of 13 |
| Dysgeusia | Nervous system disorders | 9 of 16 | 6 of 13 |
| Constipation | Gastrointestinal disorders | 7 of 16 | 6 of 13 |
| Vomiting | Gastrointestinal disorders | 7 of 16 | 6 of 13 |
| Weight loss | Investigations | 6 of 16 | 5 of 13 |
Serious events with the highest arm-level rate: febrile neutropenia (12.5%), dysphagia (12.5%), mucositis oral (12.5%), neutrophil count decreased (12.5%), anorexia (12.5%).
The safety entries list serious adverse events and other adverse events separately for each treatment group. For RT+ Cisplatin, the serious-event section lists 16 participants at risk and 6 affected; the other-event section lists 16 at risk and 16 affected. For RT + Cisplatin + Vandetanib, the serious-event section lists 13 at risk and 4 affected; the other-event section lists 13 at risk and 12 affected. These are the counts displayed in the registry record. The record does not give an adverse-event observation window or a detailed definition of the terms used.
The listed serious-event terms include Febrile neutropenia, Dysphagia, Mucositis oral, Neutrophil count decreased, Anorexia, and Dehydration, each shown as 12.5%. The registry record does not clarify the denominator or arm attribution for these term percentages, so they should not be treated as arm-specific rates. It also does not report death counts in the safety groups.
In general, counts of participants affected do not necessarily equal counts of distinct events; a participant may have more than one event. Without event-level detail, timing, severity grading, exposure duration, and definitions, the entries support only a limited description of the posted safety data. They do not establish a comparative safety effect or explain the balance of potential benefits and harms.
12. What the Result Does, and Does Not, Mean
The record documents a randomized phase II study that set out to compare radiation therapy and cisplatin with the same treatment combination plus vandetanib for disease-free survival. It gives the endpoint definition, the intended event-based timing of the primary analysis, treatment descriptions, enrollment, and some adverse-event counts. These are useful details about the question and how the trial was organized.
What the record does not provide is a completed primary-outcome comparison. It states that the trial terminated early with 34 participants accrued out of 170 planned and that no analyses were performed. There is no estimate of disease-free survival by arm, no measure of the contrast between arms, and no interval that would show the precision of an estimate. The listed planned analysis after 78 failures should not be interpreted as evidence that the event target was reached.
Accordingly, the record does not show that the two strategies had the same outcomes, and it does not show that one was better. It cannot establish equivalence, rule out an important difference, or quantify the size or direction of a difference. Those conclusions require results that are not present in the registry record. Likewise, the safety entries alone do not support a broad conclusion about comparative safety, particularly without complete definitions, follow-up context, or a clear mapping of the listed event terms to treatment groups.
In general, a negative or inconclusive statistical result requires an analysis and an estimate with uncertainty; absence of a reported analysis is different. Here, the primary outcome was not analyzed according to the record, so the appropriate interpretation is that the planned comparative question remains unanswered in the posted results. This is a statement about what the record documents, not medical advice or a recommendation about treatment.
Any sample-size scenarios shown alongside the page are planning illustrations, not trial outcomes and not observed power. They cannot fill the gap left by the missing primary analysis. The registry record also does not explain why the trial stopped, so the reason for termination should remain unknown rather than being attributed to the outcome, safety, recruitment, or another cause.
13. Why This Trial Matters Statistically
This trial matters statistically because its design and its available results illustrate two different things: a clear comparative question can be specified, but the planned analysis may not be available in the public record. Randomization and an explicit primary endpoint describe how the study intended to answer its question. They do not guarantee that an estimate will ultimately be produced or that the posted information will be sufficient for an outcome comparison.
The endpoint was time to a defined failure event, and analysis was planned after 78 failures. That event-driven framework makes the distinction between a planned analysis threshold and an observed event count especially important. The registry record provides the threshold but says that no analyses were performed. Readers should therefore avoid treating design details as outcome evidence.
The contrast also highlights why precision matters. Even if a study reports an estimate, the confidence interval is needed to understand how uncertain that estimate is. In this record, neither an estimate nor an interval is posted for disease-free survival. There is no basis to quantify the comparative effect or its precision, and no valid inference of equivalence can be made from non-reporting.
Finally, the safety section demonstrates that a small collection of counts and event-term percentages needs context before it can be interpreted comparatively. Denominators, observation periods, definitions, arm attribution, and how multiple events per participant are handled all affect what the figures mean. The registry record gives some counts, but does not report all of this context. Careful interpretation means describing what is present, identifying what is absent, and not extending a partial record into a treatment conclusion.
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 most important trial-specific limitation in the posted results is that the primary analysis was not performed. The record states that the trial terminated early after 34 participants were accrued out of 170 planned. It does not provide a disease-free survival estimate, comparative analysis, confidence interval, or number of observed failures. Therefore, the intended primary question cannot be answered from these results.
The reason for termination is not reported in the registry record. The record also does not explain whether the event-based analysis threshold of 78 failures was reached, revised, or rendered unattainable. No conclusion about the reason for early termination or the amount of follow-up can be drawn from the information posted.
Several design and analysis details are absent. The randomization procedure, allocation concealment, stratification, detailed statistical analysis plan, interim analyses, and sample-size rationale are not reported in the registry record. The treatment description for the vandetanib arm is incomplete, and the analysis populations, missing-data approach, and censoring rules are not specified. These gaps limit assessment of how the planned comparison would have been conducted even apart from the lack of an outcome analysis.
The safety information is also limited. It provides affected-participant counts, but does not state the observation window or full adverse-event definitions. The serious-event term percentages are not assigned to treatment groups in the posted data, and death counts are not reported. The entries should not be generalized into a complete safety profile or treated as a definitive comparative analysis.
Finally, the listed enrollment is small relative to the planned enrollment, but the record supplies no completed primary effect estimate with which to assess the resulting statistical precision. Any further claim about power, expected effect, or the likely direction of results would require information not reported in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Chemotherapy and Radiation Therapy (RT) With or Without Vandetanib in Treating Patients With High-Risk Stage III or Stage IV Head and Neck Cancer — NCT00720083.
- Registry record last updated 2015-11-17; status last verified 2015-11.
- Results first posted 2013-05-08.
- 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.
Continue through the Clinical Biostats statistical pathway
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18. Record Summary
NCT00720083 is a randomized, unmasked, parallel phase II trial sponsored by the Radiation Therapy Oncology Group. It compared radiation therapy and cisplatin with the same treatment combination plus vandetanib in high-risk postoperative advanced squamous cell carcinoma of the head and neck. The record lists 34 participants enrolled, against 170 planned, and a terminated status.
The primary endpoint was disease-free survival, defined from randomization to local, regional, or distant progression, or death, with last follow-up specified. Analysis was planned after 78 failures. The registry record states that the trial terminated early and no analyses were performed. It therefore contains no primary-outcome comparison or estimate of precision. Some serious and other adverse-event counts are posted, but important context for interpreting them is absent. The reason for termination and the detailed statistical plan are not reported in the registry record.