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 Patient Preference Study of Pazopanib Versus Sunitinib in Advanced or Metastatic Kidney Cancer (NCT01064310), a randomized phase 3 study. The primary outcome is Number of Participants With Preference for Pazopanib Versus Sunitinib as Assessed by the Patient Preference Questionnaire (PPQ).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01064310 |
| Phase | Phase 3 |
| Condition | Carcinoma, Renal Cell |
| Allocation | Randomized |
| Design model | Not Stated |
| Masking | Quadruple |
| Enrollment | 169 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Novartis Pharmaceuticals |
| Results posted | Yes |
2. Clinical Question
Population
Patients with treatment-naïve locally advanced or metastatic renal cell carcinoma. The primary analysis population was described as participants who received at least one dose in each treatment period, had no documented progressive disease at the end of Treatment Period 1, and completed the patient preference questionnaire.
Intervention
Pazopanib, taken during one of two treatment periods. In one sequence, participants received 800mg orally for 10 weeks before taking sunitinib.
Comparator
Sunitinib, also taken during one of two treatment periods. In the other sequence, participants received 50mg orally for 10 weeks before taking pazopanib.
Primary question
After experiencing both study drugs, which did participants prefer to continue: pazopanib, sunitinib, or neither? The registry does not report the counts in those preference categories.
This is a preference question rather than a conventional comparison of a single clinical outcome. The study sought to assess how differences in tolerability and safety translated into participants’ stated choice after both treatments. The preference questionnaire also asked participants who expressed a preference to identify influencing factors and the most important reason for their choice.
The study enrolled 169 participants. The registry summary describes patients who had received no prior systemic therapy for advanced or metastatic renal cell carcinoma. Its primary analysis population was narrower than the overall enrolled group: it required exposure to both treatment periods, no documented progressive disease at the end of the first period, and completion of the preference questionnaire. The registry record does not report how many participants met those criteria or how many selected each preference response.
3. Trial Design
The registry identifies this as a Phase 3 randomized, double-blind, cross-over study of pazopanib and sunitinib. Masking is recorded as quadruple. The record does not identify which roles were masked, so the label alone does not specify who knew treatment assignments.
Participants were assigned to one of two treatment sequences: pazopanib followed by sunitinib, or sunitinib followed by pazopanib. Each treatment period lasted 10 weeks, with a 2-week wash-out between periods. The registry describes the primary assessment as occurring at the end of treatment with both study drugs, with a maximum timeframe of 22 weeks. Each sequence therefore exposed a participant to both drugs, but in a different order.
The study summary says eligible patients were to be stratified by ECOG performance status, with categories 0 and 1, and by number of metastatic sites, with categories 0 and 1 versus >=2. The record does not provide a detailed account of how the randomization sequence was generated, how allocation was concealed, or how the stratification was implemented.
A cross-over design allows each participant to report a preference after receiving both treatments. As a general statistical consideration, comparisons in such designs can be affected by treatment order, changes over time, and effects that persist from the first period into the next. A wash-out period is part of the stated design, but the registry record does not report an analysis of carry-over or period effects. It also does not report the detailed statistical plan used to account for the sequence of treatments.
The study is listed as completed. Its primary objective was preference; secondary objectives included preference reasons, fatigue, quality of life, dose modifications, and safety. The registry does not report the full protocol or a sample-size justification.
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.
Period 1
| Stage | Sunitinib 50 mg Followed by Pazopanib 800 mg | Pazopanib 800 mg Followed by Sunitinib 50 mg | Open Label Pazopinib |
|---|---|---|---|
| STARTED | 82 | 86 | 0 |
| COMPLETED | 68 | 68 | 0 |
| NOT COMPLETED | 14 | 18 | 0 |
Reasons for not completing this period:
| Reason | Sunitinib 50 mg Followed by Pazopanib 800 mg | Pazopanib 800 mg Followed by Sunitinib 50 mg | Open Label Pazopinib |
|---|---|---|---|
| Adverse Event | 7 | 10 | 0 |
| Physician Decision | 1 | 0 | 0 |
| Withdrawal by Subject | 2 | 2 | 0 |
| Lack of Efficacy | 3 | 5 | 0 |
| Entered Open-label Period | 1 | 1 | 0 |
Period 2
| Stage | Sunitinib 50 mg Followed by Pazopanib 800 mg | Pazopanib 800 mg Followed by Sunitinib 50 mg | Open Label Pazopinib |
|---|---|---|---|
| STARTED | 68 | 68 | 0 |
| COMPLETED | 64 | 62 | 0 |
| NOT COMPLETED | 4 | 6 | 0 |
Reasons for not completing this period:
| Reason | Sunitinib 50 mg Followed by Pazopanib 800 mg | Pazopanib 800 mg Followed by Sunitinib 50 mg | Open Label Pazopinib |
|---|---|---|---|
| Adverse Event | 2 | 1 | 0 |
| Physician Decision | 0 | 1 | 0 |
| Entered Open-label Period | 1 | 0 | 0 |
| Lack of Efficacy | 1 | 4 | 0 |
Open Label Pazopinib
| Stage | Sunitinib 50 mg Followed by Pazopanib 800 mg | Pazopanib 800 mg Followed by Sunitinib 50 mg | Open Label Pazopinib |
|---|---|---|---|
| STARTED | 0 | 0 | 84 |
| COMPLETED | 0 | 0 | 0 |
| NOT COMPLETED | 0 | 0 | 84 |
Reasons for not completing this period:
| Reason | Sunitinib 50 mg Followed by Pazopanib 800 mg | Pazopanib 800 mg Followed by Sunitinib 50 mg | Open Label Pazopinib |
|---|---|---|---|
| Withdrawal by Subject | 0 | 0 | 1 |
| Adverse Event | 0 | 0 | 12 |
| Lack of Efficacy | 0 | 0 | 51 |
| Physician Decision | 0 | 0 | 20 |
Analysis population for the primary outcome, as defined in the registry: Modified-Intent-to-Treat (mITT) Population (used for the primary analysis): participants who received at least one dose of study treatment from each treatment period and who did not have documented progressive disease (PD) at the end of Treatment Period 1 and completed the patient preference questionnaire.
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.
| Characteristic | Unit | Sunitinib 50 mg Followed by Pazopanib 800 mg | Pazopanib 800 mg Followed by Sunitinib 50 mg | Total |
|---|---|---|---|---|
| Participants analysed | 82 | 86 | 168 | |
| Age, Continuous | Years | 62.1 (SD 9.56) | 62.2 (SD 11.35) | 62.2 (SD 10.48) |
| Sex: Female, Male: Female | Participants | 30 | 25 | 55 |
| Sex: Female, Male: Male | Participants | 52 | 61 | 113 |
| Race/Ethnicity, Customized: African American/African Heritage | participants | 1 | 0 | 1 |
| Race/Ethnicity, Customized: Asian-Central/South Asian Heritage | participants | 1 | 0 | 1 |
| Race/Ethnicity, Customized: White | participants | 74 | 83 | 157 |
| Race/Ethnicity, Customized: Missing | participants | 6 | 3 | 9 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With Preference for Pazopanib Versus Sunitinib as Assessed by the Patient Preference Questionnaire (PPQ), measured over End of treatment of both study drugs (maximum of 22 weeks).
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants with preference for pazopanib versus sunitinib, assessed with the Patient Preference Questionnaire. At the end of treatment with both study drugs, participants were asked to choose the drug taken first, the drug taken second, or no preference. Participants expressing a preference were also asked which factors influenced that choice and which was the most important reason.
This endpoint is used to capture a participant’s overall stated choice after experience with both treatments. Such a response can reflect a personal balance among the features experienced during treatment, rather than one prespecified clinical measurement alone. That is relevant to the study’s stated objective of assessing how tolerability and safety differences translated into preference. It does not, by itself, measure a clinical outcome such as disease progression or establish the cause of a participant’s choice.
The registry gives the endpoint definition and timeframe but does not report the number of participants who preferred either drug or reported no preference. It also does not report the preference questionnaire’s factor responses or the most important reasons. Because the result categories are not available, the primary comparison cannot be quantified from the registry record.
The stated analysis population was the modified-Intent-to-Treat population: participants who received at least one dose in each treatment period, had no documented progressive disease at the end of Treatment Period 1, and completed the preference questionnaire. The registry’s population description ends mid-word after the questionnaire criterion, so further detail is not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The primary endpoint is defined as a choice among the first treatment, the second treatment, or no preference after participants have experienced both drugs. However, the registry record does not report the counts or proportions in those categories. It therefore does not establish which treatment was preferred more often, how common no preference was, or how uncertain any difference might be.
No confidence interval, hypothesis test, p-value, or treatment-effect estimate for the primary endpoint is reported in the registry record. Without the category counts and a stated primary comparison, it is not possible to assess the size or precision of a difference in preference from the posted results. The endpoint is a participant-reported preference, not a direct estimate of comparative efficacy.
The study’s cross-over structure means that participants were assigned to receive both drugs in different orders. As a general statistical point, a preference recorded after both treatment periods can reflect the experiences across both periods, while the order of treatment and changes during the study may also matter. The registry does not report whether period or carry-over effects were evaluated, or how treatment sequence was incorporated into the primary analysis.
The registry reports safety counts for three groups. For sunitinib, 35 of 148 participants were recorded with serious adverse events; for pazopanib, 30 of 153; and for open label pazopanib, 15 of 84. The corresponding counts for other adverse events are 143 of 148, 142 of 153, and 73 of 84. These are registry counts, not estimates of the primary preference outcome. The record also lists serious adverse-event terms with percentages, including anaemia at 2.4%, and thrombocytopenia, fatigue, general physical health deterioration, alanine aminotransferase increased, and hypertension at 2.0% each.
Those safety summaries need to be read separately from the preference endpoint. The registry does not report how adverse events related to individual participants’ preference responses, nor does it provide a comparative statistical analysis connecting safety events to stated preference. A numerical difference in recorded event counts alone would not establish a causal explanation for preference.
For the secondary outcomes, the registry lists fatigue, quality of life, time to dose modification, dose-reduction counts and reasons, adverse events, discontinuations due to adverse events, and changes in blood pressure. Numerical results for these outcomes are not reported in the registry record. The record therefore supports a description of what was intended to be assessed, but not conclusions about those outcomes.
9. Statistical Methods Explained
The registry describes a randomized cross-over design. Randomization is intended to assign treatment sequence by chance rather than by a participant’s or investigator’s choice. In this study, the sequences were pazopanib followed by sunitinib and sunitinib followed by pazopanib. Randomization can reduce systematic differences between sequence groups, but the registry record does not report the method used to generate or conceal the allocation.
What a cross-over comparison represents
In a cross-over study, each participant receives more than one treatment in separate periods. The preference question was asked after exposure to both drugs, so the outcome reflects a participant’s stated choice after the two treatment experiences. As a general statistical explanation, having each participant experience both treatments can make a within-person comparison useful because stable characteristics of the participant are shared across periods. This does not remove the need to consider treatment order, period effects, or effects that persist after a treatment period.
The registry reports 10-week treatment periods and a 2-week wash-out period between them. A wash-out is intended, in general, to create a gap between treatments; its presence does not by itself show that any carry-over was eliminated. Whether the analysis assessed carry-over or period effects is not reported in the registry record. The record also does not report whether the preference analysis accounted for sequence assignment.
Masking and outcome assessment
The record labels the study double-blind and lists masking as quadruple. Blinding is generally used to limit the influence of knowledge about assigned treatment on care, reporting, or assessment. The registry does not identify the roles included in the quadruple-masking label or give details about how masking was maintained. The primary endpoint was based on the participant’s stated preference using a questionnaire. The questionnaire asked participants to select the first drug, the second drug, or no preference, and to identify reasons if they expressed a preference.
Analysis population
The primary analysis population is described as modified-Intent-to-Treat. It included participants who received at least one dose of study treatment in each period, had no documented progressive disease at the end of the first period, and completed the preference questionnaire. This definition focuses the analysis on participants with exposure to both treatments and an available preference response, while excluding those who did not meet the specified conditions. The number included in this population and the handling of participants with missing preference responses are not reported in the registry record.
As a general statistical consideration, restricting analysis to people who complete both periods can affect how results represent all randomized participants, particularly if completion is related to treatment experience or health status. The registry does not report a comparison of those included and excluded from the primary analysis population, nor does it describe a sensitivity analysis for missing outcomes.
Uncertainty and statistical tests
A confidence interval is a statistical range used to express uncertainty around an estimated effect. Its width depends on the amount of information and the variability in the data, along with the analysis method. A hypothesis test evaluates data against a specified null hypothesis under a chosen statistical model. Neither a confidence interval nor a test result for the preference endpoint is reported in the registry record. The category counts and analysis details needed to interpret such quantities are also not reported.
For a three-category outcome, an analysis might compare the distribution across the categories or define a particular contrast, but the registry does not report which approach was used. The record explicitly describes the endpoint as having several categories or time points and does not reduce it to one comparison. No specific model, test, covariate adjustment, or decision rule is reported in the registry record. It is therefore not appropriate to infer a particular statistical test from the endpoint title.
Planning illustrations and power
The planning assumptions described for sample-size illustrations are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The illustrations are based on a stated fraction of an observed effect. They are planning illustrations, not observed power, and they are not identified as the trial’s own design justification. The registry does not report the trial’s sample-size justification. Because the primary preference outcome is not reduced to one comparison and its observed effect is not reported, those assumptions do not supply a usable effect estimate for interpreting the primary endpoint.
In general, a sample-size calculation depends on a defined outcome contrast, an anticipated effect, and assumptions about variability or event frequency. Changing the anticipated effect changes the planning requirement. Such calculations describe what might be needed under stated assumptions; they do not show the probability that a completed study detected an effect. The registry record does not report an interim analysis plan or explain whether any formal sample-size calculation was used for this preference endpoint.
Over-dispersion and count outcomes
General explanation: over-dispersion occurs when observed variation in count data exceeds what a statistical model assumes. If a model ignores that extra variation, its uncertainty estimates can be too small. The registry lists several count-based safety and dose-modification outcomes, but does not report a model for them or indicate that over-dispersion was assessed. No conclusion about over-dispersion in this study can be drawn from the record.
10. Multiplicity, Missing Data and Analysis Populations
The study lists a primary preference outcome and several secondary outcomes: fatigue, quality of life, time to dose modification, dose-reduction counts and reasons, adverse events, discontinuations due to adverse events, and changes in systolic and diastolic blood pressure. When a study evaluates multiple outcomes or comparisons, the chance of at least one apparently notable finding can increase if no adjustment or prespecified testing strategy is used. This is a general statistical consideration, not a claim about what happened in this study.
The registry record does not report whether the secondary outcomes were tested under a hierarchy, whether any multiplicity adjustment was planned, or which outcomes were intended to support confirmatory conclusions. It also does not give a complete statistical analysis plan for the preference categories. The primary outcome is described with multiple response categories and is not reduced to one comparison, so the exact primary contrast and its multiplicity relationship to other analyses are not reported in the registry record.
The primary analysis population required participants to have received treatment in both periods, have no documented progressive disease at the end of the first period, and complete the preference questionnaire. The number meeting these criteria is not reported. The record does not describe the amount or pattern of missing data, how missing questionnaire responses were handled, or whether any imputation or sensitivity analysis was performed.
Because this is a cross-over study, completion of both periods is relevant to inclusion in the primary analysis. As a general concern, participants who do not complete both periods may differ from those who do, and that can affect how an analysis of completers relates to all randomized participants. The registry does not report enough information to assess this possibility or to determine the impact of missing outcomes.
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 | 35 | 148 | 23.6% |
| Pazopanib | 30 | 153 | 19.6% |
| Open Label Pazopanib | 15 | 84 | 17.9% |
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 | 143 of 148 |
| Pazopanib | 142 of 153 |
| Open Label Pazopanib | 73 of 84 |
Most frequent serious adverse event terms
| Event term | Organ system | Sunitinib | Pazopanib | Open Label Pazopanib |
|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 3 of 148 | 2 of 153 | 2 of 84 |
| Fatigue | General disorders | 3 of 148 | 2 of 153 | 1 of 84 |
| Alanine aminotransferase increased | Investigations | 2 of 148 | 3 of 153 | 1 of 84 |
| Hypertension | Vascular disorders | 2 of 148 | 3 of 153 | 0 of 84 |
| Thrombocytopenia | Blood and lymphatic system disorders | 3 of 148 | 0 of 153 | 0 of 84 |
| General physical health deterioration | General disorders | 3 of 148 | 0 of 153 | 0 of 84 |
| Aspartate aminotransferase increased | Investigations | 0 of 148 | 2 of 153 | 1 of 84 |
| Haematuria | Renal and urinary disorders | 2 of 148 | 1 of 153 | 0 of 84 |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 2 of 148 | 1 of 153 | 0 of 84 |
| Acute myocardial infarction | Cardiac disorders | 1 of 148 | 1 of 153 | 0 of 84 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Sunitinib | Pazopanib | Open Label Pazopanib |
|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | 49 of 148 | 63 of 153 | 45 of 84 |
| Nausea | Gastrointestinal disorders | 46 of 148 | 50 of 153 | 26 of 84 |
| Fatigue | General disorders | 42 of 148 | 43 of 153 | 25 of 84 |
| Hypertension | Vascular disorders | 37 of 148 | 32 of 153 | 13 of 84 |
| Decreased appetite | Metabolism and nutrition disorders | 30 of 148 | 32 of 153 | 18 of 84 |
| Asthenia | General disorders | 35 of 148 | 26 of 153 | 16 of 84 |
| Dysgeusia | Nervous system disorders | 40 of 148 | 25 of 153 | 12 of 84 |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | 39 of 148 | 27 of 153 | 11 of 84 |
| Vomiting | Gastrointestinal disorders | 26 of 148 | 21 of 153 | 18 of 84 |
| Mucosal inflammation | General disorders | 32 of 148 | 25 of 153 | 6 of 84 |
Serious events with the highest arm-level rate: anaemia (2.4%), thrombocytopenia (2.0%), fatigue (2.0%), general physical health deterioration (2.0%), alanine aminotransferase increased (2.0%).
The registry reports serious adverse-event counts for sunitinib, pazopanib, and open label pazopanib. The counts are 35 of 148 for sunitinib, 30 of 153 for pazopanib, and 15 of 84 for open label pazopanib. The registry’s other adverse-event counts are 143 of 148, 142 of 153, and 73 of 84, respectively. These figures describe the recorded groups; they are not the primary preference outcome.
The registry also lists serious adverse-event terms and percentages: anaemia, 2.4%; thrombocytopenia, 2.0%; fatigue, 2.0%; general physical health deterioration, 2.0%; alanine aminotransferase increased, 2.0%; and hypertension, 2.0%. These are reported as term-specific percentages. The registry record does not provide the detail needed to interpret them as treatment comparisons or to connect them with preference responses.
Safety counts need context, including the group definitions, the period of observation, and the rules for counting events. The available record identifies treatment groups but does not provide all details needed to make those counts equivalent to a randomized, period-adjusted comparison. The death counts are not reported in the registry record. The event summaries alone do not establish whether one treatment has a different safety profile or explain why a participant preferred a particular drug.
12. What the Result Does, and Does Not, Mean
The study was designed to ask participants who had experienced both pazopanib and sunitinib which treatment they preferred, or whether they had no preference. The registry provides the question, the treatment sequence structure, and the stated primary analysis population. It does not provide the numbers choosing each response. Consequently, the posted results do not allow the preference distribution or the magnitude and precision of a difference between drugs to be determined.
Preference is a distinct outcome from efficacy, safety, or quality of life. It can reflect a participant’s overall personal assessment, and the questionnaire sought to record reasons for that assessment. A stated choice does not by itself identify which treatment feature caused the choice, nor does it establish that the preferred treatment has better clinical outcomes. The registry does not report the questionnaire responses about influencing factors or the most important reason.
The safety counts are descriptive registry figures. They do not provide a complete comparative analysis, and the record does not link individual adverse-event experiences to preference responses. The listed secondary outcomes indicate further areas the study intended to assess, but their numerical findings are not reported in the registry record.
More broadly, the registry does not report the detailed analysis plan, the primary endpoint category counts, the uncertainty around a treatment comparison, or the handling of missing preference data. Those omissions limit what can be concluded statistically. The reported study design and outcomes clarify the question the trial set out to address, but they are not a substitute for the unreported results needed to answer that question.
13. Why This Trial Matters Statistically
This study illustrates a statistical question that differs from asking whether one treatment changes a clinical measurement more than another. Its primary objective was to capture a stated treatment preference after participants had experienced both drugs. That design makes the response meaningful as a report of participant choice, while also requiring careful interpretation of the treatment periods and their order.
The cross-over arrangement is important because the primary analysis focused on participants treated in both periods and able to complete the preference questionnaire. As a general statistical principle, that structure can support within-person comparisons, but it also makes completion, period effects, and carry-over relevant to interpretation. The registry states the wash-out and analysis-population criteria but does not report whether the analysis addressed these issues.
The record also shows why an endpoint definition is not enough to establish a result. It describes three possible preference responses and asks for reasons, yet does not report how many participants selected each response. Without those data, the preference distribution, its uncertainty, and any treatment contrast cannot be evaluated. The distinction between a planned outcome and a reported estimate is central to transparent interpretation.
Finally, the listed safety counts and secondary outcomes should not be treated as substitutes for the missing preference result. Their presence describes what was recorded or intended for assessment, but the registry does not report a complete comparative analysis across these measures. The trial therefore provides a useful example of how study design, endpoint definition, analysis population, and reporting completeness jointly determine what conclusions are statistically supportable.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The main limitation for interpreting the primary question is that the registry record does not report the preference-category counts. It also does not provide an effect estimate, confidence interval, p-value, or a detailed statistical analysis plan for the preference outcome. The endpoint has three possible responses, but no single comparison is specified in the posted results.
The primary analysis population excludes participants who did not receive treatment in both periods, had documented progressive disease at the end of the first period, or did not complete the questionnaire. The number included and the reasons for any exclusions or non-completion are not reported. The record also does not describe missing-data methods or sensitivity analyses, so the effect of incomplete outcome information cannot be assessed.
The cross-over design makes treatment sequence, period effects, and possible carry-over relevant statistical considerations. Although the registry reports a wash-out period, it does not report whether the analysis evaluated these factors. Details about allocation generation, allocation concealment, and the roles covered by quadruple masking are also not reported in the registry record.
Safety reporting is limited to group counts and selected serious adverse-event terms and percentages. The registry does not provide a full account of exposure-adjusted comparisons, the statistical handling of repeated treatment periods, or the relationship between safety and preference. Death counts are not reported in the registry record. The record does not report a sample-size justification, an interim analysis plan, or a multiplicity strategy for the primary and secondary outcomes.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Patient Preference Study of Pazopanib Versus Sunitinib in Advanced or Metastatic Kidney Cancer — NCT01064310.
- Registry record last updated 2017-04-17; status last verified 2017-03.
- Results first posted 2012-08-23.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The record describes a completed Phase 3 randomized, double-blind cross-over study of pazopanib and sunitinib in treatment-naïve locally advanced or metastatic renal cell carcinoma. Enrollment was 169. Participants were assigned to treatment sequences with 10 weeks on each drug and a 2-week wash-out period; masking is recorded as quadruple.
The primary endpoint was the number of participants preferring pazopanib or sunitinib, or expressing no preference, using the Patient Preference Questionnaire after both treatments. The primary analysis population required treatment in both periods, no documented progressive disease at the end of the first period, and completion of the questionnaire. The preference-category results and primary statistical comparison are not reported in the registry record.
The record lists secondary outcomes covering fatigue, quality of life, dose modification, adverse events, discontinuations, and blood pressure. It also reports safety counts for sunitinib, pazopanib, and open label pazopanib. Detailed methods for multiplicity, missing data, and cross-over effects are not reported in the registry record.