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 The Safety And Efficacy Of Sunitinib In Chinese Patients With Progressive Advanced Or Metastatic Well-Differentiated Unresectable Pancreatic Neuroendocrine Tumors (NCT02282059), a registered phase not stated study. The primary outcome is Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causalities and Treatment-related).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02282059 |
| Phase | Phase not stated |
| Condition | Pancreatic Neuroendocrine Tumors |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 100 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Pfizer |
| Results posted | Yes |
2. Clinical Question
Population
Chinese adults with progressive, advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors that were unresectable. The study summary describes patients enrolled at hospitals in China.
Intervention
Sunitinib, with at least one dose required for eligibility in the safety analysis population. The described regimen was 37.5 mg orally once a day on a continuous daily dosing schedule, with dosage modifications based on daily clinical practice.
Comparator
No randomized comparator is described. The registry record labels adverse-event groups “Sunitinib (Not Taken)” and “Sunitinib (Already Taken),” but does not establish these as comparable treatment arms. Allocation is not stated.
Primary question
How many participants experienced treatment-emergent adverse events, whether considered regardless of causality or as treatment-related, from baseline up to 8 years? The primary endpoint is a safety count, not a randomized estimate of a treatment effect.
The clinical question concerns the safety and efficacy of sunitinib in a specific patient population and routine-care setting. However, the posted primary endpoint is the number of participants with treatment-emergent adverse events. The registry also lists progression-free survival, progression-free survival by clinical judgment, overall survival, and five-year survival rate as secondary outcomes. Numerical results for those efficacy outcomes are not reported in the registry record.
The study was prospective and non-interventional. Patients were followed for overall survival or until withdrawal; participants alive after study completion were to have their survival time censored at the last date known to be alive. Treatment was described as continuing until disease progression, unacceptable toxicity, withdrawal, or final study analysis. These details explain the intended observation and treatment context, but do not turn the study into a controlled comparison. The adverse-event group labels should therefore not be read as randomized treatment assignments or as evidence of a like-for-like comparison.
3. Trial Design
This was a multicenter, prospective, non-interventional study of sunitinib in Chinese patients with progressive, advanced or metastatic, well-differentiated, unresectable pancreatic neuroendocrine tumors. The registry lists an enrollment of 100 and the study status as completed. The study began on 2014-12-12, with primary completion on 2022-12-12. It was sponsored by Pfizer.
The study summary describes eligible participants receiving at least one dose of oral sunitinib. The stated regimen was 37.5 mg once a day on continuous daily dosing, while dosage modification followed daily clinical practice. Treatment was to continue until disease progression, unacceptable toxicity, a participant’s withdrawal, or the final analysis. As a non-interventional study, it was intended to collect observations arising during clinical practice rather than assign treatment through a randomized protocol.
The safety analysis population is defined as enrolled participants who took at least one dose of study drug. The record lists adverse-event summaries in groups titled “Sunitinib (Not Taken)” and “Sunitinib (Already Taken),” as well as a total. The registry record does not explain the meaning of these group labels or state that they represent randomized arms. Allocation is not stated, and the registry explicitly cautions that the groups are not a like-for-like control comparison. Their counts should be read as posted group summaries, not as a causal contrast.
Overall survival, progression-free survival, progression-free survival by clinical judgment, and five-year survival rate are listed as secondary outcomes. The record does not provide numerical results for these endpoints. It reports 7 outcome measures and 0 analyses. The absence of posted analyses means that the listed outcomes cannot be interpreted as evidence of a specific efficacy effect from this record alone.
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: A total of 100 participants were enrolled and assigned to the study treatment, and 99 participants were treated.
Overall Study
| Stage | Sunitinib (Not Taken) | Sunitinib (Already Taken) |
|---|---|---|
| STARTED | 82 | 18 |
| Treated | 81 | 18 |
| Discontinued | 82 | 18 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 82 | 18 |
Reasons for not completing this period:
| Reason | Sunitinib (Not Taken) | Sunitinib (Already Taken) |
|---|---|---|
| Other | 15 | 3 |
| Participant refused further follow-up | 8 | 4 |
| Lost to Follow-up | 19 | 3 |
| Death | 40 | 8 |
Analysis population for the primary outcome, as defined in the registry: The safety analysis population included all enrolled participants who took at least 1 dose of the study drug.
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: Analysis population included all enrolled participants who took at least 1 dose of the study drug.
| Characteristic | Unit | Sunitinib (Not Taken) | Sunitinib (Already Taken) | Total |
|---|---|---|---|---|
| Participants analysed | 81 | 18 | 99 | |
| Age, Continuous | Years | 52.0 (24 to 73) | 49.0 (21 to 75) | 51.0 (21 to 75) |
| Age, Customized: <18 years | Participants | 0 | 0 | 0 |
| Age, Customized: 18-44 years | Participants | 26 | 5 | 31 |
| Age, Customized: 45-64 years | Participants | 40 | 11 | 51 |
| Age, Customized: >=65 years | Participants | 15 | 2 | 17 |
| Sex: Female, Male: Female | Participants | 31 | 6 | 37 |
| Sex: Female, Male: Male | Participants | 50 | 12 | 62 |
| Race/Ethnicity, Customized: Asian | Participants | 81 | 18 | 99 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causalities and Treatment-related), measured over From baseline up to 8 years.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants with treatment-emergent adverse events, including events of all causalities and events considered treatment-related. The registry defines an adverse event as an untoward medical occurrence in a participant given a medicinal product; an event need not be caused by the product. A treatment-emergent adverse event is one that first appears during treatment or worsens compared with the pretreatment state. The stated observation window is from baseline up to 8 years.
This endpoint is a count of participants, rather than a measure of how severe an event was, how long it lasted, or how often the same participant experienced events. The distinction between all-causality and treatment-related events matters: an event can occur during treatment without being attributed to the treatment. The endpoint’s definition does not itself establish causation.
As a general statistical point, safety counts are useful for describing how many people experienced an event under observation. They are not, by themselves, a comparison of risk against an untreated or randomized control group. Interpretation also depends on who was included in the safety population, how long participants were observed, and how events were collected. The registry defines the safety population as enrolled participants who took at least one dose. The primary endpoint’s overall participant count or treatment-related count is not reported in the registry record. Separate adverse-event summaries are posted, but they do not supply a complete numerical result for the primary endpoint as worded.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a safety-focused primary outcome: the number of participants with treatment-emergent adverse events over an observation window from baseline up to 8 years. It defines events broadly and distinguishes events arising during treatment from events considered related to treatment. The results posted in the adverse-event entry give counts for serious adverse events, other adverse events, and deaths in two labeled groups and in a total. The total group lists 16 participants with serious adverse events, 68 with other adverse events, and 48 deaths among 99 at risk. These categories should be kept distinct; the record does not say that deaths were caused by adverse events or by sunitinib.
The record’s overall enrollment is 100, while the adverse-event total lists 99 at risk. The record does not explain this difference. It would be inappropriate to infer why the counts differ or to treat the at-risk denominator as the full enrolled population. The safety population definition refers to enrolled participants who took at least one dose, but the record does not reconcile that definition with the posted total or clarify the “Not Taken” label.
The group counts also do not provide a valid treatment contrast. The registry says allocation was not stated and cautions that the groups are not a like-for-like control comparison. The “Not Taken” and “Already Taken” labels cannot be interpreted as randomized exposure assignments on the available information. Differences between their counts could reflect group composition, exposure, observation time, or other factors; the registry record does not provide enough information to distinguish these explanations. No causal effect estimate should be inferred from these summaries.
The serious-event terms listed most prominently are Disease progression, Oedema peripheral, Foreign body, Malignant neoplasm progression, Neoplasm progression, and Pneumothorax, each reported as 5.6%. Those entries describe the reported terms and percentages. They do not establish that each term affected the same number of participants, that each was treatment-related, or that the percentages can be summed. The registry does not give further context for these terms in the posted entry.
Although progression-free survival, progression-free survival by clinical judgment, overall survival, and five-year survival rate are listed as secondary outcomes, their numerical results and analyses are not reported in the registry record. The available results therefore support a descriptive reading of posted safety counts only. They do not establish efficacy, comparative safety, or a treatment effect.
9. Statistical Methods Explained
The registry identifies the study as prospective and non-interventional. In general, a prospective study defines what will be observed and follows participants forward in time. A non-interventional design observes treatment in clinical practice rather than assigning participants to treatment arms through randomization. Such a design can describe outcomes in the observed population, but causal interpretation is limited when treatment exposure and other participant characteristics are not controlled by random assignment.
What does a participant count represent?
The primary endpoint is a count of participants with treatment-emergent adverse events. A participant count records whether a person experienced an event meeting the endpoint definition; it is not a count of every event episode. The registry defines treatment-emergent events as events that emerge during treatment after being absent before treatment, or that worsen relative to the pretreatment state. It also says adverse events need not be causally related to the medicinal product. Thus “treatment-emergent” describes timing or change from baseline, whereas “treatment-related” is a separate attribution.
The safety analysis population includes enrolled participants who took at least one dose. A population definition determines who contributes to a safety summary. The adverse-event entry lists 99 at risk in its total group, while the record lists enrollment of 100. The record does not explain the difference, so no conclusion about exclusions, missing observations, or exposure can be drawn from it.
Why are serious and other events shown separately?
Serious adverse events and other adverse events are different categories in the registry entry. The posted summaries report participant counts at risk and affected, along with deaths. These are descriptive counts. They do not, on their own, indicate whether an event was caused by treatment or how long each participant was followed. The top serious terms are presented with percentages, but the record does not provide additional details about their derivation or participant overlap. A participant may have more than one event; therefore event-term entries should not be added to obtain a participant total.
What can a comparison say?
Randomization, when used, can make treatment groups more comparable on average by chance, supporting a stronger causal comparison. Here, allocation is not stated, and the registry cautions that the adverse-event groups are not a like-for-like control comparison. The labels “Sunitinib (Not Taken)” and “Sunitinib (Already Taken)” do not establish how participants entered each group or whether they were followed in the same way. Their counts can be described as posted, but an unadjusted difference between them would not automatically represent a treatment effect. The registry reports 0 analyses, and no inferential comparison is reported.
How should uncertainty be understood?
In general, a confidence interval expresses the range of values compatible with the observed data and a stated statistical procedure. It conveys uncertainty around an estimate; it does not remove bias from a nonrandomized design or make non-comparable groups comparable. The registry record does not report confidence intervals or a model-based estimate for the primary safety endpoint. No numerical uncertainty interval should be inferred from the counts alone.
Over-dispersion is a general issue that arises when observed variability is greater than a statistical model expects. It can affect standard errors and confidence intervals in analyses of rates or counts. The registry record does not report an over-dispersion assessment or a statistical model for the posted safety summaries. It is therefore not possible to say whether such a feature was assessed or adjusted for.
What do the planning illustrations mean?
The sample-size assumptions describe planning illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is described as a stated fraction of the observed effect. These are illustrations, not a description of the study’s own design. The record does not report a randomized two-arm design, and it cautions against treating the adverse-event groups as comparable controls. Planning sample sizes are not observed power and do not establish that the study had a particular probability of detecting an effect. The registry record does not report its own sample-size justification, statistical plan, or power calculation.
For time-to-event outcomes, censoring is used when the event time is not observed during follow-up. The study summary states that participants alive after study completion would have overall survival censored at the last date known to be alive, and that follow-up could end at withdrawal. This describes intended handling in broad terms; the detailed time-to-event analysis methods, censoring counts, and outcome estimates are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 7 outcome measures, including the primary safety endpoint and secondary outcomes of progression-free survival, progression-free survival by clinical judgment, overall survival, and five-year survival rate. It reports 0 analyses. A multiplicity plan explains how interpretation accounts for testing several outcomes or comparisons, since a larger set of tests can increase the chance of a chance-positive finding. Such a plan is not reported in the registry record, nor are endpoint-specific inferential results available to assess how multiplicity was handled.
Missing-data methods are also not reported in the registry record. The study summary says participants would be followed for overall survival or until withdrawal and that participants alive after study completion would have their survival time censored at the last date known to be alive. This is a general description of survival follow-up, not a full account of missing observations or data handling. The record does not report how missing safety assessments, incomplete follow-up, or unavailable outcome measurements were addressed.
The safety analysis population is defined as enrolled participants who took at least one dose. The adverse-event total lists 99 at risk, while enrollment is 100; the registry does not reconcile these figures. The adverse-event groups are labeled “Sunitinib (Not Taken)” and “Sunitinib (Already Taken),” but the record does not explain the labels or establish a randomized allocation. Allocation is not stated, and the record cautions that the groups are not a like-for-like control comparison. These details limit interpretation of both population membership and any apparent between-group pattern.
Interim analyses, a detailed statistical analysis plan, and methods for handling missing data are not reported in the registry record. Their absence should not be interpreted as proof that a particular method was or was not used outside the posted record.
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 |
|---|---|---|---|
| Sunitinib (Not Taken) | 11 | 81 | 13.6% |
| Sunitinib (Already Taken) | 5 | 18 | 27.8% |
| Total | 16 | 99 | 16.2% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Sunitinib (Not Taken) | 40 of 81 |
| Sunitinib (Already Taken) | 8 of 18 |
| Total | 48 of 99 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Sunitinib (Not Taken) | 55 of 81 |
| Sunitinib (Already Taken) | 13 of 18 |
| Total | 68 of 99 |
Most frequent serious adverse event terms
| Event term | Organ system | Sunitinib (Not Taken) | Sunitinib (Already Taken) | Total |
|---|---|---|---|---|
| Disease progression | General disorders | 2 of 81 | 1 of 18 | 3 of 99 |
| Cachexia | Metabolism and nutrition disorders | 3 of 81 | 0 of 18 | 3 of 99 |
| Febrile neutropenia | Blood and lymphatic system disorders | 1 of 81 | 0 of 18 | 1 of 99 |
| Myelosuppression | Blood and lymphatic system disorders | 1 of 81 | 0 of 18 | 1 of 99 |
| Duodenal obstruction | Gastrointestinal disorders | 1 of 81 | 0 of 18 | 1 of 99 |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | 1 of 81 | 0 of 18 | 1 of 99 |
| Death | General disorders | 1 of 81 | 0 of 18 | 1 of 99 |
| Oedema peripheral | General disorders | 0 of 81 | 1 of 18 | 1 of 99 |
| Jaundice cholestatic | Hepatobiliary disorders | 1 of 81 | 0 of 18 | 1 of 99 |
| Biliary tract infection | Infections and infestations | 1 of 81 | 0 of 18 | 1 of 99 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Sunitinib (Not Taken) | Sunitinib (Already Taken) | Total |
|---|---|---|---|---|
| White blood cell count decreased | Investigations | 27 of 81 | 9 of 18 | 36 of 99 |
| Neutrophil count decreased | Investigations | 25 of 81 | 7 of 18 | 32 of 99 |
| Platelet count decreased | Investigations | 26 of 81 | 6 of 18 | 32 of 99 |
| Anaemia | Blood and lymphatic system disorders | 19 of 81 | 6 of 18 | 25 of 99 |
| Aspartate aminotransferase increased | Investigations | 11 of 81 | 5 of 18 | 16 of 99 |
| Alanine aminotransferase increased | Investigations | 11 of 81 | 3 of 18 | 14 of 99 |
| Neutropenia | Blood and lymphatic system disorders | 7 of 81 | 5 of 18 | 12 of 99 |
| Vomiting | Gastrointestinal disorders | 9 of 81 | 3 of 18 | 12 of 99 |
| Gamma-glutamyltransferase increased | Investigations | 7 of 81 | 5 of 18 | 12 of 99 |
| Diarrhoea | Gastrointestinal disorders | 7 of 81 | 4 of 18 | 11 of 99 |
Serious events with the highest arm-level rate: disease progression (5.6%), oedema peripheral (5.6%), foreign body (5.6%), malignant neoplasm progression (5.6%), neoplasm progression (5.6%).
The adverse-event entry reports participant counts at risk and affected for serious events, other events, and deaths. In the “Sunitinib (Not Taken)” group, 11 of 81 at risk are reported with serious adverse events, 55 of 81 with other adverse events, and 40 deaths. In the “Sunitinib (Already Taken)” group, the corresponding counts are 5 of 18, 13 of 18, and 8. The total group lists 16 of 99 with serious adverse events, 68 of 99 with other adverse events, and 48 deaths.
These are descriptive registry counts. The labels do not establish that the groups are randomized or comparable, and the record explicitly cautions against treating them as like-for-like controls. The death counts should not be read as deaths caused by an adverse event or by sunitinib; cause and attribution are not reported in this summary. Likewise, the “other” category should not be given a more specific clinical meaning than the record provides.
The listed serious-event terms are Disease progression, Oedema peripheral, Foreign body, Malignant neoplasm progression, Neoplasm progression, and Pneumothorax, each reported as 5.6%. The record does not explain whether terms overlap within participants or provide further detail on attribution. These percentages should not be added or treated as a complete event distribution.
12. What the Result Does, and Does Not, Mean
The posted results describe safety observations in a prospective, non-interventional study of sunitinib among Chinese patients with progressive, unresectable advanced or metastatic well-differentiated pancreatic neuroendocrine tumors. The adverse-event entry provides serious-event, other-event, and death counts, as well as several serious-event terms. Such information can characterize what was recorded in the study population and can indicate the kinds of safety data collected in routine clinical practice.
The counts do not establish that sunitinib caused the reported events. The registry definition allows adverse events that are not causally related to treatment, and the serious-event summaries do not identify event-level attribution. Nor do the counts establish comparative safety: allocation is not stated, the record warns that the groups are not like-for-like controls, and the group labels are not explained. The numerical pattern across the labels therefore cannot be interpreted as a causal treatment contrast.
The primary endpoint is defined as the number of participants with treatment-emergent adverse events, but an overall result for that endpoint is not reported in the registry record. The separate counts are not enough to reconstruct the full primary endpoint or its treatment-related component. The listed secondary efficacy outcomes have no numerical results in the record. Consequently, these results do not show whether sunitinib improved or worsened tumor outcomes, survival, or any other efficacy endpoint.
General statistical interpretation also depends on how long each person was observed, how complete follow-up was, how outcomes were assessed, and what analysis was planned. The record describes survival censoring at the last date known to be alive for participants who remained alive after study completion, but it does not report detailed missing-data methods or outcome analyses. The findings should therefore be understood as limited descriptive registry reporting, not as a definitive estimate of treatment benefit, harm relative to another option, or individual prognosis.
13. Why This Trial Matters Statistically
This trial matters statistically because it illustrates the distinction between a prospective observational safety study and a randomized comparison. A prospective design can collect information over time, and the non-interventional setting may reflect treatment and assessment in routine clinical practice. At the same time, the absence of stated random allocation means that group summaries cannot be assumed to control for differences among participants or differences in care.
It also shows why endpoint definitions matter. “Treatment-emergent” identifies events that arise during treatment or worsen from pretreatment status, while “treatment-related” concerns attribution. Those ideas are not interchangeable. A count of participants with events is also different from an event count, a rate over person-time, or a time-to-event estimate. Reading the endpoint definition alongside the way results are reported helps avoid treating unlike measures as equivalent.
The record further illustrates the importance of reconciling analysis populations and denominators. Enrollment is listed as 100, while the total adverse-event group reports 99 at risk. Without an explanation, the difference cannot be assigned to a particular cause. Clear accounting of who was included and why is necessary for readers to understand the reach and limits of safety summaries.
Finally, a completed study record does not necessarily contain results for every listed outcome. Here, efficacy outcomes are identified, but numerical results and analyses are not reported in the registry record. Statistical conclusions must therefore track the evidence actually posted: descriptive safety counts are available, while comparative estimates and efficacy findings are not. That distinction helps prevent overinterpretation of nonrandomized group labels or of event counts as treatment effects.
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 posted record has several trial-specific limitations for statistical interpretation. It describes a non-interventional study, gives no stated allocation method, and cautions that the adverse-event groups are not a like-for-like control comparison. The labels “Sunitinib (Not Taken)” and “Sunitinib (Already Taken)” are not explained. These features prevent a sound causal comparison between the groups based on their counts.
Enrollment is listed as 100, but the adverse-event total reports 99 at risk. The record does not explain the difference. The safety analysis population is defined as enrolled participants who took at least one dose, but the group labels and totals do not make the relationship between that definition and the reported counts clear. No additional population flow or accounting is reported.
The primary endpoint is specified, yet its overall participant count and treatment-related count are not reported as a complete endpoint result. The record provides serious and other adverse-event summaries and deaths, but does not report detailed attribution or event timing for those counts. The listed efficacy outcomes have no numerical results, and the record reports 0 analyses. Confidence intervals, adjusted estimates, and detailed statistical methods are not reported in the registry record.
The registry does not report the study’s sample-size justification, interim-analysis plan, multiplicity approach, detailed missing-data methods, or a full statistical analysis plan. Follow-up is described in general terms, including censoring for participants alive after study completion at the last date known to be alive, but detailed censoring and completeness information is not reported. These gaps limit assessment of precision, potential bias, and how fully the observed outcomes represent the enrolled population.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: The Safety And Efficacy Of Sunitinib In Chinese Patients With Progressive Advanced Or Metastatic Well-Differentiated Unresectable Pancreatic Neuroendocrine Tumors — NCT02282059.
- Registry record last updated 2024-06-20; status last verified 2024-06.
- Results first posted 2024-06-20.
- 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
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
This is a completed, multicenter, prospective, non-interventional study of sunitinib in Chinese patients with progressive, advanced or metastatic, well-differentiated, unresectable pancreatic neuroendocrine tumors. Enrollment is listed as 100. The primary endpoint is the number of participants with treatment-emergent adverse events, with a stated timeframe from baseline up to 8 years.
The adverse-event entry reports serious-event, other-event, and death counts for two labeled groups and a total. The total group lists 16 participants with serious adverse events, 68 with other adverse events, and 48 deaths among 99 at risk. The record cautions that the groups are not a like-for-like control comparison. Efficacy outcomes are listed, but numerical results are not reported in the registry record. The record reports 7 outcome measures and 0 analyses.