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 Study On Fatigue- And Hand-Foot Syndrome-Related Quality Of Life In Patients With Metastatic Renal Cell Carcinoma Receiving A Tyrosine Kinase Inhibitor as First-Line Treatment (NCT02789137), a registered phase not stated study. The primary outcome is Number of Participants Categorized According to the Napping Habits for All Participants at Baseline.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02789137 |
| Phase | Phase not stated |
| Condition | Metastatic Renal Cell Carcinoma |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 111 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Pfizer |
| Results posted | Yes |
2. Clinical Question
Population
Patients with metastatic renal cell carcinoma who were receiving a tyrosine kinase inhibitor as first-line treatment. The study description focuses on fatigue- and hand-foot syndrome-related quality of life. It enrolled 111 participants; eligibility details beyond the stated population are not reported in the registry record.
Intervention
This was an observational study, not a trial assigning a treatment. The listed treatments were sunitinib, pazopanib, and sorafenib. The registry record does not report how treatment was selected or how long each participant received treatment.
Comparator
The listed treatment groups are sunitinib and pazopanib in the adverse-event information. Sorafenib appears in the study description, but no corresponding group figures are reported in the registry record. These groups are not a like-for-like control comparison, and allocation is not stated.
Primary question
At baseline, how many evaluable participants were classified as never, always, or sometimes taking daytime naps? The measure describes napping habits. It does not itself quantify fatigue, hand-foot syndrome, or overall quality of life.
The study’s stated broader purpose was to understand quality of life among people receiving the listed treatments who experience fatigue and hand-foot syndrome, including personal variability and possible ways to mitigate these effects. The primary registered measure is narrower: it classifies daytime rest habits at baseline. The registry record does not report the number of participants in each napping category, so the distribution cannot be described from the registered primary outcome information.
3. Trial Design
The TROYA study is described as a prospective, multicentre, observational study of patients with metastatic renal cell carcinoma receiving a tyrosine kinase inhibitor as first-line treatment. The registry lists sunitinib, pazopanib, and sorafenib as treatments of interest. The record gives an enrollment of 111 and a status of completed. The recorded study start was 2016-12-22, and the primary completion date was 2020-10-20.
Because the study is observational, its treatment groups should not be read as groups assigned under a randomized comparison. The registry record explicitly indicates that this is not a randomized comparison and that allocation is not stated. It therefore does not establish that differences between treatment groups, if any, arose from treatment rather than from differences in the people receiving each treatment or other factors.
The registry lists a primary measure at baseline: participant counts according to daytime napping habit. It defines the categories as never, always, and sometimes. The broader study description concerns fatigue- and hand-foot syndrome-related quality of life, but the registry record does not report a schedule of later assessments or detail how those broader topics were measured. Other design details, including eligibility criteria, recruitment procedures, treatment duration, and follow-up plans, are not reported in the registry record.
The registry record lists 36 outcome measures and 0 analyses. The primary measure’s stated population consists of eligible participants included in the study who were evaluable for that outcome. The number evaluable for the primary measure is not reported in the registry record. A protocol, allocation procedure, or detailed statistical analysis plan is not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Tyrosine Kinase Inhibitor |
|---|---|
| STARTED | 111 |
| COMPLETED | 53 |
| NOT COMPLETED | 58 |
Reasons for not completing this period:
| Reason | Tyrosine Kinase Inhibitor |
|---|---|
| Dropped out/Died | 58 |
Analysis population for the primary outcome, as defined in the registry: Analysis population included all eligible participants who were included in this study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
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 eligible participants whose data was collected and analyzed in this study.
| Characteristic | Unit | Tyrosine Kinase Inhibitor |
|---|---|---|
| Participants analysed | 111 | |
| Age, Continuous | Years | 62.9 (SD 10.7) |
| Sex: Female, Male: Female | Participants | 31 |
| Sex: Female, Male: Male | Participants | 80 |
| Race and Ethnicity Not Collected | Participants | — |
| Eastern Cooperative Oncology Group Performance Status (ECOG PS) Less Than or Equal to (<=) 2: 0 | Participants | 55 |
| Eastern Cooperative Oncology Group Performance Status (ECOG PS) Less Than or Equal to (<=) 2: 1 | Participants | 45 |
| Eastern Cooperative Oncology Group Performance Status (ECOG PS) Less Than or Equal to (<=) 2: 2 | Participants | 11 |
| Heng Prognostic Criteria: Favourable | Participants | 28 |
| Heng Prognostic Criteria: Intermediate | Participants | 57 |
| Heng Prognostic Criteria: Poor prognosis | Participants | 26 |
| Site of Metastasis: Lung | Participants | 73 |
| Site of Metastasis: Brain | Participants | 3 |
| Site of Metastasis: Nodes | Participants | 38 |
| Site of Metastasis: Bone | Participants | 29 |
| Site of Metastasis: Liver | Participants | 26 |
| Site of Metastasis: Kidney | Participants | 9 |
| Site of Metastasis: Other | Participants | 32 |
| Number of Metastatic Sites: 1 | Participants | 47 |
| Number of Metastatic Sites: 2 | Participants | 36 |
| Number of Metastatic Sites: 3 | Participants | 19 |
| Number of Metastatic Sites: 4 | Participants | 6 |
| Number of Metastatic Sites: 5 | Participants | 3 |
| Histological Type: Clear cell | Participants | 86 |
| Histological Type: Chromophobe | Participants | 3 |
| Histological Type: Papillary type 1 | Participants | 4 |
| Histological Type: Papillary type 2 | Participants | 5 |
| Histological Type: Mixed | Participants | 3 |
| Histological Type: Sarcomatoid | Participants | 2 |
| Histological Type: Not performed | Participants | 8 |
| Smoking Status: No | Participants | 79 |
| Smoking Status: Yes | Participants | 20 |
| Smoking Status: Occasional | Participants | 1 |
| Smoking Status: Former Smoker | Participants | 11 |
| Time Elapsed From the Time of Diagnosis of the Disease | Months | 31.5 (SD 56.9) |
| Time Elapsed From the Time of Advanced Diagnosis of the Disease | Months | 2.6 (SD 4.8) |
| Number of Participants Categorized According to Tyrosine Kinase Inhibitor Dose and Treatment Regimen: Pazopanib 800 mg daily without rest da | Participants | 11 |
| Number of Participants Categorized According to Tyrosine Kinase Inhibitor Dose and Treatment Regimen: Sunitinib 50 mg, Regimen 4/2 | Participants | 83 |
| Number of Participants Categorized According to Tyrosine Kinase Inhibitor Dose and Treatment Regimen: Sunitinib 50 mg, Regimen 2/1 | Participants | 10 |
| Number of Participants Categorized According to Tyrosine Kinase Inhibitor Dose and Treatment Regimen: Sunitinib 37.5 mg, Regimen 4/2 | Participants | 2 |
| Number of Participants Categorized According to Tyrosine Kinase Inhibitor Dose and Treatment Regimen: Sunitinib 37.5 mg, Regimen 2/1 | Participants | 3 |
| Number of Participants Categorized According to Tyrosine Kinase Inhibitor Dose and Treatment Regimen: Sunitinib 25 mg, Regimen 2/1 | Participants | 2 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants Categorized According to the Napping Habits for All Participants at Baseline, measured over Baseline.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary measure counts participants by their daytime napping habit at baseline. The registry defines “never” as taking no daytime naps, “always” as taking daytime naps daily, and “sometimes” as taking daytime naps on weekends or holidays. The measure’s unit is participants, and its stated analysis population includes eligible participants enrolled in the study who were evaluable for this outcome.
These categories provide a descriptive snapshot of one daily-life behavior. Recording such habits may be relevant to understanding how participants experience fatigue and quality of life, but the registered measure is not a direct fatigue score, a hand-foot syndrome severity assessment, or a quality-of-life scale. It also does not, by itself, show whether napping changed during treatment or whether a treatment caused a particular habit.
The registry record does not report the baseline counts in the three categories or the number evaluable for this measure. Thus, the endpoint’s definition is available, but its observed distribution cannot be interpreted from the registry outcome information. The reason for selecting this measure as primary is not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The primary outcome is defined clearly enough to understand what was intended to be counted: participants classified by daytime napping habit at baseline. However, the registry record does not report the number classified as never, always, or sometimes. Without those counts, it is not possible to describe which category was most common, how the categories were distributed, or how complete the outcome data were.
The registry lists 36 outcome measures but 0 analyses. It does not report an estimate of an association between napping and fatigue, hand-foot syndrome, treatment, or quality of life. It also does not report a confidence interval, a significance test, an adjusted estimate, or a comparison of the treatment groups for the primary outcome. Consequently, no estimate of the size or precision of any such relationship can be drawn from the registered results.
The adverse-event information provides descriptive counts for the sunitinib and pazopanib groups. It lists 23 participants with serious adverse events among 100 at risk for sunitinib, and 5 among 11 at risk for pazopanib. Other adverse events are listed for 82 among 100 at risk for sunitinib and 6 among 11 at risk for pazopanib. The registry also lists 17 deaths in the sunitinib group and 1 in the pazopanib group. These are group-specific counts, not a randomized treatment comparison. The registry record does not establish that treatment caused the events or deaths.
The groups differ in their reported numbers at risk, and treatment allocation is not stated. In an observational study, differences in participant characteristics, clinical circumstances, or follow-up can affect group results. The registry record does not report information sufficient to assess those factors or to make an adjusted comparison. The listed serious adverse-event terms include percentages, but the denominator and calculation details for those percentages are not reported in the registry record.
Any sample-size figures displayed as planning illustrations should be understood as hypothetical design calculations based on an observed effect and stated assumptions, not as evidence that a planned sample size was achieved or that the study had a particular probability of detecting an effect. The registry record does not provide the primary outcome counts or analyses needed to judge the strength or precision of the napping result.
9. Statistical Methods Explained
The available information supports a descriptive reading of the primary outcome, not a reconstruction of a full statistical analysis. The registry gives the endpoint definition, the intended analysis population, and the total enrollment. It does not report the primary outcome counts or an analysis plan. The statistical concepts below explain how such information is generally interpreted; they do not imply that any particular procedure was used in this study.
What does a participant count describe?
General: A count reports how many people fall into a defined category. For this outcome, the categories are never, always, and sometimes taking daytime naps, with each category defined in the registry. Counts are easiest to interpret alongside the number of participants assessed, because the count alone does not establish what share of the assessed group it represents. The registry record does not report the category counts or the number evaluable for this outcome.
The endpoint is measured at baseline, so its intended interpretation is a description at that assessment point. A baseline classification does not show whether a participant’s habits later changed. It also cannot establish whether napping is a response to fatigue, a cause of a later outcome, or simply associated with other characteristics. Those questions require suitable measurements and analyses, which are not reported in the registry record.
What can an observational comparison establish?
General: In an observational study, people are not necessarily assigned to treatments by chance. The groups receiving different treatments may differ before treatment or in other ways relevant to outcomes. A difference in observed results between groups can therefore reflect those differences as well as treatment. Random allocation can help balance such factors on average, but the registry characterizes this study as not a randomized comparison and says allocation is not stated.
The registry names sunitinib, pazopanib, and sorafenib in the study description, while the adverse-event information gives group counts for sunitinib and pazopanib. Those counts describe what was recorded in each group. They do not by themselves provide a causal contrast. The registry record does not report an adjusted model, a method for controlling confounding, or a direct analysis comparing the treatment groups.
What does precision mean?
General: An estimate describes a quantity calculated from observed data; a confidence interval describes a range of values that are compatible with the data under the method’s assumptions. Greater uncertainty generally results when information is limited or outcomes are uncommon, but the size of that uncertainty depends on the data and analysis. No confidence interval or primary-outcome estimate is reported in the registry record, so precision for the napping categories cannot be assessed.
For event counts, the size of the group at risk matters when interpreting the count. A count from a smaller group can be less stable than a similar count from a larger group. The reported at-risk counts for the serious and other adverse-event summaries are 100 for sunitinib and 11 for pazopanib. This descriptive context does not make the groups comparable, and no uncertainty interval for the adverse-event figures is reported in the registry record.
How should planning illustrations be read?
General: A sample-size calculation estimates how many participants or events a future or planned study would require under selected assumptions. The record’s planning assumptions specify a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is stated as a fraction of the observed effect. For time-to-event calculations, the stated quantity is the total number of events; other calculations refer to participants per arm.
Such calculations are planning illustrations, not observed outcomes and not “observed power.” Their interpretation depends on the assumptions and the effect used for planning. They do not establish that the present observational study was designed using those assumptions. The registry record does not report the study’s own sample-size justification, and the assumptions for a planning illustration should not be mistaken for a documented protocol analysis plan.
The record lists 36 outcome measures and 0 analyses. It does not specify which statistical tests, models, or estimation procedures were used, whether analyses were adjusted, or how uncertainty was calculated. A more detailed statistical account cannot be inferred from the endpoint definitions and group counts alone.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 36 outcome measures and 0 analyses. With multiple outcomes, there can be more than one opportunity to identify an apparently notable result. General: Multiplicity refers to the interpretive issue created when many outcomes or statistical tests are considered. A prespecified plan may define a primary outcome and explain whether and how other results are adjusted or treated as exploratory. The registry record does not report a multiplicity strategy, the number of tests conducted, or whether any adjustment was used.
The primary outcome population is described as all eligible participants included in the study who were evaluable for the outcome. The record explains that the overall number analyzed means participants evaluable for this measure, but does not give that number or the number with missing napping information. It does not report how missing observations were handled, why observations might be missing, or whether the analysis population differed from the enrolled population.
Enrollment was 111, but that figure should not be assumed to be the denominator for every outcome. An outcome-specific denominator depends on who was assessed and had usable data for that outcome. The registry record does not report the primary outcome’s denominator, or the corresponding missing-data details. It also does not report whether any sensitivity analyses were performed to assess the influence of missing data.
Without these details, the completeness and robustness of the primary outcome result cannot be evaluated. The absence of a reported analysis does not establish what analyses may have been conducted outside the registry; it means the registry record does not present them.
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 | 23 | 100 | 23.0% |
| Pazopanib | 5 | 11 | 45.5% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Sunitinib | 17 of 100 |
| Pazopanib | 1 of 11 |
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 |
|---|---|
| Sunitinib | 82 of 100 |
| Pazopanib | 6 of 11 |
Most frequent serious adverse event terms
| Event term | Organ system | Sunitinib | Pazopanib |
|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | 6 of 100 | 0 of 11 |
| Thrombocytopenia | Blood and lymphatic system disorders | 5 of 100 | 0 of 11 |
| Asthenia | General disorders | 2 of 100 | 1 of 11 |
| Renal failure | Renal and urinary disorders | 1 of 100 | 1 of 11 |
| Diarrhoea | Gastrointestinal disorders | 1 of 100 | 1 of 11 |
| Mucosal inflammation | General disorders | 2 of 100 | 0 of 11 |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | 2 of 100 | 0 of 11 |
| Hypertension | Vascular disorders | 2 of 100 | 0 of 11 |
| Hepatotoxicity | Hepatobiliary disorders | 0 of 100 | 1 of 11 |
| Cardiotoxicity | Cardiac disorders | 1 of 100 | 0 of 11 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Sunitinib | Pazopanib |
|---|---|---|---|
| Asthenia | General disorders | 53 of 100 | 4 of 11 |
| Mucosal inflammation | General disorders | 40 of 100 | 1 of 11 |
| Diarrhoea | Gastrointestinal disorders | 35 of 100 | 3 of 11 |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | 28 of 100 | 2 of 11 |
| Hypertension | Vascular disorders | 21 of 100 | 1 of 11 |
| Skin toxicity | Skin and subcutaneous tissue disorders | 18 of 100 | 0 of 11 |
| Dysgeusia | Nervous system disorders | 16 of 100 | 1 of 11 |
| Neutropenia | Blood and lymphatic system disorders | 10 of 100 | 0 of 11 |
| Thrombocytopenia | Blood and lymphatic system disorders | 9 of 100 | 0 of 11 |
| Dyspepsia | Gastrointestinal disorders | 9 of 100 | 0 of 11 |
Serious events with the highest arm-level rate: hepatotoxicity (9.1%), renal failure (9.1%), diarrhoea (9.1%), asthenia (9.1%), dysgeusia (9.1%).
The registry lists serious adverse events for two treatment groups. For sunitinib, 23 participants were affected among 100 at risk; for pazopanib, 5 were affected among 11 at risk. It lists other adverse events for 82 participants among 100 at risk for sunitinib and 6 among 11 at risk for pazopanib. The death counts are 17 for sunitinib and 1 for pazopanib.
These figures are descriptive counts. The groups are not a randomized comparison, and allocation is not stated. The counts therefore should not be interpreted as establishing that one treatment caused more or fewer events, or that the events or deaths were caused by treatment. The registry record does not report the event follow-up period or details needed to interpret differences in exposure or participant characteristics.
The listed serious adverse-event terms include hepatotoxicity, renal failure, diarrhoea, asthenia, and dysgeusia, each reported as 9.1%, and neutropenia, reported as 6.0%. The denominator and calculation details for these percentages are not reported in the registry record. They should be read as the registry’s reported term percentages, not as a basis for comparing treatment risks.
12. What the Result Does, and Does Not, Mean
The registry record establishes the study’s stated focus and the definition of its primary measure. TROYA examined quality of life related to fatigue and hand-foot syndrome among patients with metastatic renal cell carcinoma receiving a tyrosine kinase inhibitor as first-line treatment. Its primary registered measure counts participants according to daytime napping habit at baseline. The record also provides descriptive adverse-event counts for sunitinib and pazopanib.
The primary outcome counts are not reported in the registry record. Therefore, the registered information does not show how participants were distributed among the napping categories. It also does not show whether napping was associated with fatigue, hand-foot syndrome, quality of life, or a particular treatment. No primary-outcome estimates or analyses are reported, so the direction, magnitude, and precision of a relationship cannot be assessed.
The adverse-event figures should not be treated as evidence that one treatment is safer or less safe than another. This is an observational study, not a randomized comparison, and allocation is not stated. The reported groups may differ in ways that affect event counts. The figures also do not establish that a treatment caused an event or death.
General: A study result is most informative when the outcome, denominator, analysis, and uncertainty are all available. Here, the outcome definitions and some group counts are recorded, but the primary category counts, outcome-specific denominator, analysis details, and uncertainty estimates are not reported in the registry record. The record can therefore describe the study’s intent and selected safety counts, but it does not support a quantitative conclusion about its primary question.
13. Why This Trial Matters Statistically
This study is statistically notable for the distinction between its broad stated purpose and its registered primary measure. The description concerns fatigue- and hand-foot syndrome-related quality of life, while the primary outcome is a baseline classification of daytime napping habits. These concepts may be relevant to one another, but they are not interchangeable measures. A napping category cannot stand in for a validated symptom score or a direct measure of quality of life.
The observational design is also important. Treatment groups can be informative in an observational study, but they do not automatically support a causal treatment comparison. The registry states that this is not a randomized comparison and that allocation is not stated. Interpretation must therefore distinguish descriptive group counts from evidence of a treatment effect.
The registry record illustrates why endpoint definitions and reported results are both needed. The primary measure is defined, and the study enrollment is 111, yet the category counts and number evaluable for that measure are not reported. Without them, readers cannot assess the observed distribution, denominator, or precision. The record lists 36 outcome measures and 0 analyses, while providing selected safety counts; that difference in reporting should not be mistaken for a complete statistical account.
These features matter for clinical research interpretation because the question, design, analysis population, and reported estimates jointly determine what conclusions a study can support. The available information allows a careful description of the study’s scope and limits, but not a quantitative answer to its primary napping question or a causal comparison of the treatments.
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 principal limitation for interpreting the primary outcome is that the registry record does not report the counts in the never, always, and sometimes napping categories. It also does not report the number evaluable for that outcome. Although enrollment is 111, the evaluable population may differ, and the record does not provide an outcome-specific denominator.
The study is observational and is explicitly not a randomized comparison; allocation is not stated. As a result, the treatment groups should not be treated as exchangeable controls. The registry record does not report participant characteristics by treatment group, treatment selection procedures, or an adjusted comparison that could help address confounding.
The broader stated focus is quality of life related to fatigue and hand-foot syndrome, but the primary outcome described is baseline napping habit. The registry record does not report the instruments or detailed measurement procedures used for the broader quality-of-life topics, or how these relate analytically to the primary outcome. It also does not report follow-up timing for the outcomes.
Other limitations include the lack of reported missing-data methods, multiplicity procedures, confidence intervals, and statistical analysis details. The record lists 36 outcome measures and 0 analyses. The adverse-event counts are available for sunitinib and pazopanib, but the registry does not report the context necessary for a causal safety comparison. The listed serious-event term percentages also lack reported denominators and calculation details. Finally, although sorafenib is named in the study description, corresponding adverse-event group figures are not reported in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Study On Fatigue- And Hand-Foot Syndrome-Related Quality Of Life In Patients With Metastatic Renal Cell Carcinoma Receiving A Tyrosine Kinase Inhibitor as First-Line Treatment — NCT02789137.
- Registry record last updated 2021-11-05; status last verified 2021-10.
- Results first posted 2021-11-05.
- 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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18. Record Summary
TROYA was a completed prospective, multicentre, observational study of patients with metastatic renal cell carcinoma receiving a tyrosine kinase inhibitor as first-line treatment. The registry lists sunitinib, pazopanib, and sorafenib in the study description, an enrollment of 111, a start date of 2016-12-22, and a primary completion date of 2020-10-20.
The primary measure counts participants by daytime napping habit at baseline: never, always, or sometimes. The registry record does not report the category counts, the number evaluable for this measure, or primary-outcome analyses. It lists 36 outcome measures and 0 analyses. Descriptive serious and other adverse-event counts and death counts are reported for sunitinib and pazopanib, but the study is not a randomized comparison and allocation is not stated. These counts do not establish causal treatment effects.