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Primary objective: to increase knowledge about safety, tolerability, quality of life and efficacy under conditions of routine use of SUTENT®. Secondary objectives: treatment response, hypothyroidism prevalence.The efficacy will be assessed using the Objective Response Rate, Time to Progression based on the RECIST criteria and the ECOG performance data.
180 patients will be enrolled at 20 key oncological centres, the sample size is sufficient for exploratory analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients treated with SUTENT® | Patients with metastatic or advanced renal cell carcinoma after failure of cytokines therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SUTENT | Drug | SUTENT® hard gelatin capsules containing 12.5 mg, 25 mg or 50 mg equivalent of sunitinib malate; daily dosage of 50 mg for 4 consecutive weeks followed by a 2-week rest period. Sutent is administered until disease progression or occurrence of unacceptable toxicity. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Objective Response | Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR). CR is defined as the disappearance of all target lesions. PR is defined as at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. | 12 months |
| Progression-free Survival (PFS) | The period from study entry until disease progression, death, or date of last contact. | Baseline to measured progressive disease (up to 12 months) |
| Overall Survival (OS) | OS is the duration from enrollment to death. | Baseline to date of death (up to 12 months) |
| Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Week 6 | Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair >50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants in "Not reported" category were on study, had no data for this time point. | Week 6 |
| Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 3 | Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair >50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants in "Not reported" category were on study, had no data for this time point. |
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| Measure | Description | Time Frame |
|---|---|---|
| Summary of Adverse Events for Participants Who Required Dose Modification | Adverse events (AEs) or treatment-emergent adverse events (TEAEs) were defined as newly occurring or worsening after first dose. Study drug modifications included reduced dose or temporary discontinuation of treatment. | Baseline up to 12 months |
Inclusion Criteria:
Exclusion Criteria:
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Patients with metastatic and/or advanced renal cell carcinoma after failure of cytokines therapy.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Brno | 625 00 | Czechia | |||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sunitinib | The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Month 3 |
| Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 6 | Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair >50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants in "Not reported" category were on study, had no data for this time point. | Month 6 |
| Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 9 | Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair >50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants in "Not reported" category were on study, had no data for this time point. | Month 9 |
| Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 12 | Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair >50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants in "Not reported" category were on study, had no data for this time point. | Month 12 |
| Correlation Between Sunitinib-induced Hypertension and Tumor Response to Treatment (PFS) | Sunitinib-induced hypertension was determined using blood pressure recorded at each postbaseline visit. Once participants were identified as having sunitinib-induced hypertension, they retained that status at subsequent visits. PFS is the time from start of study treatment to first documentation of tumor response to treatment. Hazard ratio represents the relationship between sunitinib-induced hypertension and PFS (presence/absence of hypertension). | Baseline to date of first documentation of response to treatment (up to 12 months) |
| Correlation Between Sunitinib-induced Hypertension and Tumor Response to Treatment (OS) | Sunitinib-induced hypertension was determined using blood pressure recorded at each postbaseline visit. Once participants were identified as having sunitinib-induced hypertension, they retained that status at subsequent visits. OS is the time from start of study treatment to death. Hazard ratio represents the relationship between sunitinib-induced hypertension and OS. | Baseline to date of death (up to 12 months) |
| Percentage of Participants With Hypothyroidism | TSH and FT4 levels were measured and hypothyroidism was defined as a TSH level >5.0 mIU/L at that time point. | Baseline, Months 3, 6, 9, 12 |
| Percentage of Participants With Hypertension | Hypertension was defined as follows. Grade 1: Asymptomatic, transient (less than [<]24 hours) increase by >20mm Hg (diastolic) or to >150/100 mm Hg if previously within normal limits (WNL). Grade 2: Recurrent or persistent (24 hours or more) or symptomatic increase by >20 mm Hg (diastolic) or to >150/100 mm Hg if previously WNL. Grade 3: Requiring >1 drug or more intensive therapy than previously. Grade 4: Life-threatening. Grade 5: Death. | Baseline, Week 6, Months 3, 6, 9, 12 |
| Percentage of Participants With Treatment-emergent Hypertension, by Common Terminology Criteria for Adverse Events (CTCAE) Grade |
Sunitinib-induced hypertension: not present at baseline but developed through the study, or if present at baseline increased by more than (>) 20% during the study. Grade 1: Asymptomatic, transient (less than [<]24 hours) increase by >20 millimeters of Mercury (mm Hg) (diastolic) or to >150/100 mm Hg if previously within normal limits (WNL); Grade 2: Recurrent or persistent (>=24 hours) or symptomatic increase by >20 mm Hg (diastolic) or to >150/100 mm Hg if previously WNL; Grade 3: Requiring >1 drug or more intensive therapy than previously; Grade 4: Life-threatening; Grade 5: Death. |
| Baseline up to 12 months |
| Percentage of Participants Responding to Treatment | Response categories for target lesions: Complete response (CR): Disappearance of all target lesions; Partial response (PR): At least a 30% decrease in the sum of the longest dimensions, reference=baseline sum of longest dimensions; Progressive disease (PD): At least a 20% increase in the sum of the longest dimensions, or the appearance of 1 or more new lesions; Stable disease (SD): Not sufficient shrinkage to qualify for PR, not sufficient increase to qualify for PD; Reference for PD and SD: smallest sum of longest dimensions since treatment started. | 12 months |
| Brno |
| 656 53 |
| Czechia |
| Pfizer Investigational Site | Brno | 656 91 | Czechia |
| Pfizer Investigational Site | Chomutov | 430 12 | Czechia |
| Pfizer Investigational Site | České Budějovice | 370 87 | Czechia |
| Pfizer Investigational Site | Fryštát | 735 06 | Czechia |
| Pfizer Investigational Site | Hradec Králové | 500 05 | Czechia |
| Pfizer Investigational Site | Jihlava | 586 33 | Czechia |
| Pfizer Investigational Site | Liberec | 460 63 | Czechia |
| Pfizer Investigational Site | Nová Ves pod Pleší | 26204 | Czechia |
| Pfizer Investigational Site | Nový Jičín | 741 01 | Czechia |
| Pfizer Investigational Site | Ostrava | 703 84 | Czechia |
| Pfizer Investigational Site | Ostrava | 708 52 | Czechia |
| Pfizer Investigational Site | Pardubice | 532 03 | Czechia |
| Pfizer Investigational Site | Pilsen | 301 00 | Czechia |
| Pfizer Investigational Site | Prague | 100 34 | Czechia |
| Pfizer Investigational Site | Prague | 128 08 | Czechia |
| Pfizer Investigational Site | Prague | 140 59 | Czechia |
| Pfizer Investigational Site | Prague | 150 00 | Czechia |
| Pfizer Investigational Site | Zlín | 639 00 | Czechia |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sunitinib | The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| ||||||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||||||||
| Involvement of Regional Lymph Nodes | The sum of participants may not be equal to the number of participants beginning the study. A participant may be included in more than one category, or a participant may not be included in any category. | Number | participants |
| |||||||||||||||||||||||||
| Previous Anti-Tumor Therapy | The sum of participants may not be equal to the number of participants beginning the study. A participant may be included in more than one category, or a participant may not be included in any category. | Number | participants |
| |||||||||||||||||||||||||
| Eastern Cooperative Oncology Group (ECOG) Performance Status | ECOG criteria: 0: Fully active. 1: Ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of all selfcare. 3: Capable of limited selfcare, confined to bed or chair more than 50% of waking hours. 4: Completely disabled, no selfcare, totally confined to bed or chair. 5: Dead. | Number | percentage of participants |
| |||||||||||||||||||||||||
| Frequency of Involved Disease Sites | The sum of participants may not be equal to the number of participants beginning the study. A participant may be included in more than one category, or a participant may not be included in any category. | Number | participants |
| |||||||||||||||||||||||||
| Prevalence of hypothyroidism | At baseline, participants were considered hypothyroid if the investigator indicated they had hypothyroidism (yes/no) on the case report form (CRF). At subsequent visits, thyroid-stimulating hormone (TSH) and free thyroxine (FT4) levels were measured and hypothyroidism was defined as a TSH level greater than (>)5.0 milli-International Units per liter (mIU/L) at that visit. | Number | participants |
| |||||||||||||||||||||||||
| Prevalence of Hypertension | Hypertension was defined as blood pressure >140/90 millimeters of Mercury (mm Hg). At baseline, presence/absence of hypertension was recorded. If either the presence/absence of hypertension question or the blood pressure at Baseline indicated that the participant currently had hypertension, then the participant was considered to have hypertension at baseline. At subsequent visits, hypertension status was determined in terms of the blood pressure recorded at that visit. | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Objective Response | Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR). CR is defined as the disappearance of all target lesions. PR is defined as at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. | Full analysis set (FAS): all participants who received at least one dose of the study medication. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 months |
|
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| |||||||||||||||||||||||||
| Primary | Progression-free Survival (PFS) | The period from study entry until disease progression, death, or date of last contact. | FAS | Posted | Median | 95% Confidence Interval | months | Baseline to measured progressive disease (up to 12 months) |
|
| ||||||||||||||||||||||||||
| Primary | Overall Survival (OS) | OS is the duration from enrollment to death. | FAS | Posted | Median | 95% Confidence Interval | months | Baseline to date of death (up to 12 months) |
|
| ||||||||||||||||||||||||||
| Primary | Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Week 6 | Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair >50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants in "Not reported" category were on study, had no data for this time point. | FAS. Percentages based on entire FAS population. | Posted | Number | percentage of participants | Week 6 |
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| Primary | Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 3 | Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair >50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants in "Not reported" category were on study, had no data for this time point. | FAS. Percentages based on entire FAS population. | Posted | Number | percentage of participants | Month 3 |
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| Primary | Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 6 | Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair >50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants in "Not reported" category were on study, had no data for this time point. | FAS. Percentages based on entire FAS population. | Posted | Number | percentage of participants | Month 6 |
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| Primary | Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 9 | Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair >50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants in "Not reported" category were on study, had no data for this time point. | FAS. Percentages based on entire FAS population. | Posted | Number | percentage of participants | Month 9 |
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| Primary | Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 12 | Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair >50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants in "Not reported" category were on study, had no data for this time point. | FAS. Percentages based on entire FAS population. | Posted | Number | percentage of participants | Month 12 |
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| Primary | Correlation Between Sunitinib-induced Hypertension and Tumor Response to Treatment (PFS) | Sunitinib-induced hypertension was determined using blood pressure recorded at each postbaseline visit. Once participants were identified as having sunitinib-induced hypertension, they retained that status at subsequent visits. PFS is the time from start of study treatment to first documentation of tumor response to treatment. Hazard ratio represents the relationship between sunitinib-induced hypertension and PFS (presence/absence of hypertension). | FAS | Posted | Number | participants | Baseline to date of first documentation of response to treatment (up to 12 months) |
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| Primary | Correlation Between Sunitinib-induced Hypertension and Tumor Response to Treatment (OS) | Sunitinib-induced hypertension was determined using blood pressure recorded at each postbaseline visit. Once participants were identified as having sunitinib-induced hypertension, they retained that status at subsequent visits. OS is the time from start of study treatment to death. Hazard ratio represents the relationship between sunitinib-induced hypertension and OS. | FAS | Posted | Number | participants | Baseline to date of death (up to 12 months) |
|
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| Primary | Percentage of Participants With Hypothyroidism | TSH and FT4 levels were measured and hypothyroidism was defined as a TSH level >5.0 mIU/L at that time point. | FAS. n = number of participants with evaluable data at that time point. | Posted | Number | percentage of participants | Baseline, Months 3, 6, 9, 12 |
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| Primary | Percentage of Participants With Hypertension | Hypertension was defined as follows. Grade 1: Asymptomatic, transient (less than [<]24 hours) increase by >20mm Hg (diastolic) or to >150/100 mm Hg if previously within normal limits (WNL). Grade 2: Recurrent or persistent (24 hours or more) or symptomatic increase by >20 mm Hg (diastolic) or to >150/100 mm Hg if previously WNL. Grade 3: Requiring >1 drug or more intensive therapy than previously. Grade 4: Life-threatening. Grade 5: Death. | FAS. n = number of participants with evaluable data at that time point. | Posted | Number | percentage of participants | Baseline, Week 6, Months 3, 6, 9, 12 |
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| Other Pre-specified | Summary of Adverse Events for Participants Who Required Dose Modification | Adverse events (AEs) or treatment-emergent adverse events (TEAEs) were defined as newly occurring or worsening after first dose. Study drug modifications included reduced dose or temporary discontinuation of treatment. | Number of participants analyzed = All participants who required dose modification because of an adverse event. The total number of participants may exceed the number of participants analyzed because one participant may have reported more than one adverse event. | Posted | Number | participants | Baseline up to 12 months |
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| Other Pre-specified | Percentage of Participants With Treatment-emergent Hypertension, by Common Terminology Criteria for Adverse Events (CTCAE) Grade | Sunitinib-induced hypertension: not present at baseline but developed through the study, or if present at baseline increased by more than (>) 20% during the study. Grade 1: Asymptomatic, transient (less than [<]24 hours) increase by >20 millimeters of Mercury (mm Hg) (diastolic) or to >150/100 mm Hg if previously within normal limits (WNL); Grade 2: Recurrent or persistent (>=24 hours) or symptomatic increase by >20 mm Hg (diastolic) or to >150/100 mm Hg if previously WNL; Grade 3: Requiring >1 drug or more intensive therapy than previously; Grade 4: Life-threatening; Grade 5: Death. | All participants | Posted | Number | percentage of participants | Baseline up to 12 months |
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| Other Pre-specified | Percentage of Participants Responding to Treatment | Response categories for target lesions: Complete response (CR): Disappearance of all target lesions; Partial response (PR): At least a 30% decrease in the sum of the longest dimensions, reference=baseline sum of longest dimensions; Progressive disease (PD): At least a 20% increase in the sum of the longest dimensions, or the appearance of 1 or more new lesions; Stable disease (SD): Not sufficient shrinkage to qualify for PR, not sufficient increase to qualify for PD; Reference for PD and SD: smallest sum of longest dimensions since treatment started. | All participants | Posted | Number | percentage of participants | 12 months |
|
|
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The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sunitinib | The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics. | 31 | 186 | 52 | 186 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Diverticulum intestinal | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Empyema | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hypochloraemia | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
| |
| Cerebellar syndrome | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Renal disorder | Renal and urinary disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Dermatitis exfoliative | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Infarction | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Periodontitis | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Adverse event | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Face oedema | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Herpes dermatitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Blood parathyroid hormone increased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
| |
| False positive investigation result | Investigations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Skin erosion | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Skin toxicity | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Varicose vein | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| Paracaval |
|
| Prior Hormonal Therapy |
|
| Prior Immunotherapy |
|
| Prior Cancer Surgeries |
|
|
| ECOG Performance Status 2 |
|
| ECOG Performance Status 3 |
|
| ECOG Performance Status 4 |
|
| ECOG Performance Status 5 |
|
| Chest wall |
|
| Kidney |
|
| Liver |
|
| Lung |
|
| Lymph node |
|
| Lymph node - Mediastinum |
|
| Lymph node - Other |
|
| Lymph node - Retroperitoneal |
|
| Lymph node - Supraclavicular |
|
| Lymph node - Regional |
|
| Mediastinum |
|
| Other |
|
| Pancreas |
|
| Pelvis |
|
| Peritoneum |
|
| Pleura |
|
| Skin |
|
| Spleen |
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
|
|
|
|
|
|
|
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Baseline (n=186) |
| |||||
| Month 3 (n=168) |
| |||||
| Month 6 (n=131) |
| |||||
| Month 9 (n=100) |
| |||||
| Month 12 (n=134) |
|
|
|
|
|