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The study was terminated early due to the inability to recruit the planned number of patients
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OPTIMISE is designed to provide knowledge regarding the use of Sunitinib as 1st line treatment and 2nd line treatment selected (Sunitinib-different sequence) with respect to efficacy outcomes, adverse events, and health related QoL in the real life setting.
OPTIMISE study objectives are dual and aim primarily to increase the knowledge regarding the outcomes from Sunitinib use on one hand; and outcomes from the combined Sunitinib-2nd line sequence on the other hand in real life clinical practice.
This will be addressed in many countries across AfME and in individual country cohorts to understand specificities and differences in use and outcomes
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sunitinib | Drug | Sunitinib is an FDA approved targeted therapy for use as first line therapy for patients with metastatic renal cell carcinoma. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | PFS was defined as the time from when the participant received the first dose of sunitinib to the time of progression or death due to any cause, which occurred first. The time of progression was the date of the first tumor assessment where the progression was notified as response to therapy, over the sunitinib treatment. Participants who discontinued the study for any reason, including unacceptable toxicity during the treatment period, who remained alive and without disease progression, were censored at the last disease assessment that verified lack of disease progression. As per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, disease progression was defined as at least a 20% increase (including an absolute increase of at least 5 millimeters [mm]) in the sum of the longest dimensions of the target lesions taking as a reference smallest sum of the longest dimensions recorded since the treatment started, or the appearance of 1 or more new lesions. | From date of first dose of sunitinib to date of progression or death or censored date, whichever occurred first (up to maximum of 36 months) |
| Time to Treatment Failure (TTF) | TTF was defined as the time from when the participant received the first dose of sunitinib to the time of sunitinib discontinuation (date completed by the physician). In case of death when the participant was still treated with sunitinib, date of death was considered as date of discontinuation. If no sunitinib discontinuation was reported during the follow-up visits, participants were censored to the last follow-up visit. | From date of first dose of sunitinib until the date of discontinuation or censored date (up to maximum of 36 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) at Months 3, 6, 9 and 12 | ORR was defined as the percentage of participants with confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.1. As per RECIST 1.1 criteria: CR = disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis); PR = at least 30% decrease in sum of diameters of target lesions taking as reference baseline sum diameters. |
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Inclusion Criteria:
Patients being treated with SU as 1st line treatment according to the approved therapeutic indication.
Histologically confirmed diagnosis of mRCC (clear cell RCC as well as nonclear cell RCC) with measurable disease according to RECIST 1.1
Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Exclusion Criteria:
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Adult patients with metastatic renal cell carcinoma being treated with Sunitinib as the first line therapy.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pierre Et Marie Curie Center | Algers | 16005 | Algeria | |||
| CAC Annaba |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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A total of 77 participants with advanced RCC were enrolled in the study, of which 3 participants were excluded from analysis as they were not eligible. Only 74 enrolled participants were eligible to be included in the analysis of the study. Data was collected in routine clinical practice and from medical records.
Participants aged 18 years and above diagnosed with advanced metastatic renal cell cancer (mRCC) and treated with sunitinib as first line treatment according to the approved therapeutic indication in real world practice were enrolled in this observational study. Participants were enrolled across Africa and Middle East (AfME) countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sunitinib | Eligible participants diagnosed with mRCC, who on enrollment into the study, initiated treatment with sunitinib as first line treatment in real world clinical routine practice, were included. Data was collected in routine clinical practice and studied from medical records. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Full analysis set included all eligible participants enrolled in the study, whatever the therapeutic strategy used during the observation period.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sunitinib | Eligible participants diagnosed with mRCC, who on enrollment into the study, initiated treatment with sunitinib as first line treatment in real world clinical routine practice, were included. Data was collected in routine clinical practice and studied from medical records. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Progression Free Survival (PFS) | PFS was defined as the time from when the participant received the first dose of sunitinib to the time of progression or death due to any cause, which occurred first. The time of progression was the date of the first tumor assessment where the progression was notified as response to therapy, over the sunitinib treatment. Participants who discontinued the study for any reason, including unacceptable toxicity during the treatment period, who remained alive and without disease progression, were censored at the last disease assessment that verified lack of disease progression. As per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, disease progression was defined as at least a 20% increase (including an absolute increase of at least 5 millimeters [mm]) in the sum of the longest dimensions of the target lesions taking as a reference smallest sum of the longest dimensions recorded since the treatment started, or the appearance of 1 or more new lesions. | Full analysis set included all eligible participants enrolled in the study, whatever the therapeutic strategy used during the observation period. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | Median | Inter-Quartile Range | Days | From date of first dose of sunitinib to date of progression or death or censored date, whichever occurred first (up to maximum of 36 months) |
From date of sunitinib first dose until end of follow-up (up to maximum of 36 months)
An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.
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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 | Eligible participants diagnosed with mRCC, who on enrollment into the study, initiated treatment with sunitinib as first line treatment in real world clinical routine practice, were included. Data was collected in routine clinical practice and studied from medical records. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 13, 2016 | Jan 22, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 7, 2018 | Jan 22, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Months 3, 6, 9 and 12 |
| Number of Participants With Recommended Starting Dose of Sunitinib | The recommended starting dose of sunitinib was 50 milligrams (mg) per day, 4 weeks on treatment followed by 2 weeks off. | At initiation of sunitinib (Day 0) |
| Number of Participants With Other Starting Doses | Number of participants with other starting doses of sunitinib (50 mg per day, 2 weeks on, 1 week off; 37.5 mg per day for 2 weeks on and 1 week off; 25 mg per day for 2 weeks on and 1 week off; 37.5 mg per day 4 weeks on and 2 weeks off) were reported in this outcome measure. | At initiation of sunitinib (Day 0) |
| Number of Participants With Moderate Chronic Liver Failure, With 2 Milligrams (mg) Twice Daily (BID) as Starting Dose | At initiation of sunitinib (Day 0) |
| Average Dose Received Over the Sunitinib Treatment Period | During treatment period (up to 12 months) |
| Dose Intensity of Sunitinib | Dose intensity was defined as defined as the sum of sunitinib daily doses divided by the duration of sunitinib treatment in days (delay between the first sunitinib dose and the last dose, including temporary interruption). | During treatment period (up to 12 months) |
| Number of Participants With Change in Dose or Schedule of Sunitinib | Number of participants with change in dose or schedule of sunitinib at the specified time points were reported in this outcome measure. | Month 3, 6, 9 and 12 |
| Number of Participants With Dose Increase | During treatment period (up to 12 months) |
| Number of Participants With Temporary Interruption During the Sunitinib Treatment Period | During treatment period (up to 12 months) |
| Time to First Interruption | During treatment period (up to 12 months) |
| Time to All Interruptions | During treatment period (up to 12 months) |
| Number of Participants According to Reasons for Temporary Interruption | Number of participants according to reasons for temporary interruption (adverse events, logistical, personal and intolerant to sunitinib) at specified time points is presented in this outcome measure. | Months 3, 6, 9 and 12 |
| Number of Participants With Sunitinib Discontinuation | Number of participants with sunitinib discontinuation at specified time points is presented in this outcome measure. | Months 3, 6, 9 and 12 |
| Number of Participants According to Reasons for Sunitinib Discontinuation | Number of participants according to reasons for sunitinib discontinuation (death, intolerability, progression) at specified time points is presented in this outcome measure. | Months 3, 6, 9 and 12 |
| Median Duration of Sunitinib Treatment | Median duration of treatment was defined as the time between the sunitinib initiation and the sunitinib discontinuation date or the last follow-up date with sunitinib treatment. | From date of first dose of sunitinib until discontinuation or last follow-up date with sunitinib treatment (up to maximum of 36 months) |
| Combined Progression Free Survival | Combined PFS was defined as the time from when the participants received the first dose of sunitinib as first line, until progression or death due to any cause while on the 2nd line treatment, whichever occurred first during the 2nd line sequence treatment. As per RECIST version 1.1, disease progression was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of the longest dimensions of the target lesions taking as a reference smallest sum of the longest dimensions recorded since the treatment started, or the appearance of 1 or more new lesions. | From date of first dose of sunitinib until progression or death whichever occurred first during second line treatment (up to maximum of 36 months) |
| Combined TTF for the Sunitinib-2nd Line Sequence | Combined TTF was defined as the time from when the participant received the first dose with sunitinib as first line, to the time of 2nd line sequence discontinuation (date completed by the physician). | From date of first dose of sunitinib until discontinuation of second line treatment (up to maximum of 36 months) |
| Combined PFS According to Type of Second Line Treatment | Combined PFS was defined as the time from when the participants received the first dose of sunitinib as first line, until progression or death due to any cause while on the 2nd line treatment, whichever occurred first during the 2nd line sequence treatment. As per RECIST version 1.1, disease progression was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of the longest dimensions of the target lesions taking as a reference smallest sum of the longest dimensions recorded since the treatment started, or the appearance of 1 or more new lesions. Combined PFS according to the type of second line treatment (best supportive care [BSC], tyrosine kinase inhibitors [TKI] including pazopanib and mammalian target of rapamycin [mTOR] inhibitors including everolimus) were reported in this outcome measure. | From date of first dose of sunitinib until progression or death whichever occurred first during second line treatment (up to maximum of 36 months) |
| Overall Survival | Overall survival was defined as the time from date of first sunitinib dose to the date of death of any cause. | From date of first dose of sunitinib to the date of death of any cause (up to maximum of 36 months) |
| Number of Participants Experiencing At Least One Adverse Event (AE) of Any Grade | An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. AEs were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) as follows: Grade 1: mild AE, Grade 2: moderate AE, Grade 3: severe AE, Grade 4: life-threatening consequences and urgent intervention indicated, Grade 5: death related to AE. In this outcome measure, number of participants with at least one AE of any grade is reported. | From date of sunitinib first dose until end of follow-up (up to maximum of 36 months) |
| Number of Most Common AEs of Any Grade by Preferred Term | An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. AEs were graded according to NCI-CTCAE as follows: Grade 1: mild AE, Grade 2: moderate AE, Grade 3: severe AE, Grade 4: life-threatening consequences and urgent intervention indicated, Grade 5: death related to AE. In this outcome measure, number of most common AEs of any grade is presented. Only events captured as deaths (preferred term) are reported as deaths in the data table. | From date of sunitinib first dose until end of follow-up (up to maximum of 36 months) |
| Number of Events of Diarrhea, Hypertension, Fatigue, Asthenia, Palmar-plantar Erythrodysesthesia Syndrome, Nausea, Stomatitis, Neutropenia, Lymphopenia and Elevated Lipase | Number of events of diarrhea, hypertension, fatigue, asthenia, palmar-plantar erythrodysesthesia syndrome, nausea, stomatitis, neutropenia, lymphopenia and elevated lipase were reported in this outcome measure. | From date of sunitinib first dose until end of follow-up (up to maximum of 36 months) |
| Number of Participants With Serious Adverse Events and Non-Serious AEs | A serious adverse event was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) at any dose that: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect. In this outcome measure, number of participants with serious adverse events and non-serious adverse events are reported. | From date of sunitinib first dose until end of follow-up (up to maximum of 36 months) |
| Number of Adverse Events According to Grade | An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. AEs were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) as follows: Grade 1: mild AE, Grade 2: moderate AE, Grade 3: severe AE, Grade 4: life-threatening consequences and urgent intervention indicated, Grade 5: death related to AE. | From date of sunitinib first dose until end of follow-up (up to maximum of 36 months) |
| Number of Participants Who Discontinued Treatment Due to AEs | An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. In this outcome measure, number of participants who discontinued treatment due to AEs are reported. | From date of sunitinib first dose until end of follow-up (up to maximum of 36 months) |
| Duration of Treatment Until Discontinuation for AEs | An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. | From date of sunitinib first dose until end of follow-up (up to maximum of 36 months) |
| Number of Participants Who Died Due to Any Cause | From date of sunitinib first dose until end of follow-up (up to maximum of 36 months) |
| Number of Participants According to the Cause of Death | From date of sunitinib first dose until end of follow-up (up to maximum of 36 months) |
| Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (FKSI-19) Total Scores | The FKSI-19 is a disease-specific instrument that assessed symptoms of importance in renal cancer participants. It consisted of 4 subscales (FKSI-Disease Related Symptoms [DRS]-Physical [P]-12 items, FKSI-DRS-Emotional [E]-1 item, treatment side effects [TSE]-3 items, functional wellbeing [FWB]-3 items). Participants were required to respond to a total of 19 questions regarding symptoms, side effects and wellbeing on a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). The total FKSI scores were calculated as the sum of the item responses divided by the number of items completed multiplied by the total number of items in the scale and ranged from 0 (severely symptomatic) to 76 (asymptomatic), where higher scores indicated better health. | Day 0, Month 3, 6, 9, 12, 18 and 24 |
| Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (FKSI-19) Sub-scale Scores | The FKSI-19 is a disease-specific instrument that assessed symptoms of importance in renal cancer participants. It consisted of 4 subscales (FKSI-DRS-P: 12 items, FKSI-DRS-E: 1 item, TSE: 3 items, FWB: 3 items). Participants were required to respond to the items in each subscale on a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). The FKSI subscale scores were calculated as the sum of item responses divided by the number of items completed multiplied by the total number of items in the subscale and ranged from 0 (severely symptomatic) to 48 (asymptomatic) for FKSI-DRS-P, 0 (severely symptomatic) to 4 (asymptomatic) for FKSI-DRS-E and 0 (severely symptomatic) to 12 (asymptomatic) for TSE and FWB; higher scores indicated better health. | Day 0, Month 3, 6, 9, 12, 18 and 24 |
| Annaba |
| Algeria |
| Hanene Djedi | Annaba | Algeria |
| Kasr Al Aini | Cairo | 11562 | Egypt |
| National Cancer Institute | Cairo | 11796 | Egypt |
| Demerdash Hospital | Cairo | Egypt |
| Kuwait Cancer Control Center | Kuwait City | 70653 | Kuwait |
| Institut National D'Oncologie | Rabat | Morocco |
| Physician Decision |
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| Withdrawal by Subject |
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| Lost to Follow-up |
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| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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|
| Primary | Time to Treatment Failure (TTF) | TTF was defined as the time from when the participant received the first dose of sunitinib to the time of sunitinib discontinuation (date completed by the physician). In case of death when the participant was still treated with sunitinib, date of death was considered as date of discontinuation. If no sunitinib discontinuation was reported during the follow-up visits, participants were censored to the last follow-up visit. | Full analysis set included all eligible participants enrolled in the study, whatever the therapeutic strategy used during the observation period. | Posted | Median | Inter-Quartile Range | Days | From date of first dose of sunitinib until the date of discontinuation or censored date (up to maximum of 36 months) |
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| Secondary | Objective Response Rate (ORR) at Months 3, 6, 9 and 12 | ORR was defined as the percentage of participants with confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.1. As per RECIST 1.1 criteria: CR = disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis); PR = at least 30% decrease in sum of diameters of target lesions taking as reference baseline sum diameters. | Full analysis set included all eligible participants enrolled in the study, whatever the therapeutic strategy used during the observation period. | Posted | Number | Percentage of participants | Months 3, 6, 9 and 12 |
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| Secondary | Number of Participants With Recommended Starting Dose of Sunitinib | The recommended starting dose of sunitinib was 50 milligrams (mg) per day, 4 weeks on treatment followed by 2 weeks off. | Full analysis set included all eligible participants enrolled in the study, whatever the therapeutic strategy used during the observation period. | Posted | Count of Participants | Participants | At initiation of sunitinib (Day 0) |
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| Secondary | Number of Participants With Other Starting Doses | Number of participants with other starting doses of sunitinib (50 mg per day, 2 weeks on, 1 week off; 37.5 mg per day for 2 weeks on and 1 week off; 25 mg per day for 2 weeks on and 1 week off; 37.5 mg per day 4 weeks on and 2 weeks off) were reported in this outcome measure. | Full analysis set included all eligible participants enrolled in the study, whatever the therapeutic strategy used during the observation period. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | At initiation of sunitinib (Day 0) |
|
|
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| Secondary | Number of Participants With Moderate Chronic Liver Failure, With 2 Milligrams (mg) Twice Daily (BID) as Starting Dose | Full analysis set included all eligible participants enrolled in the study, whatever the therapeutic strategy used during the observation period. | Posted | Count of Participants | Participants | At initiation of sunitinib (Day 0) |
|
|
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| Secondary | Average Dose Received Over the Sunitinib Treatment Period | Full analysis set included all eligible participants enrolled in the study, whatever the therapeutic strategy used during the observation period. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Milligrams | During treatment period (up to 12 months) |
|
|
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| Secondary | Dose Intensity of Sunitinib | Dose intensity was defined as defined as the sum of sunitinib daily doses divided by the duration of sunitinib treatment in days (delay between the first sunitinib dose and the last dose, including temporary interruption). | Full analysis set included all eligible participants enrolled in the study, whatever the therapeutic strategy used during the observation period. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Milligrams per day | During treatment period (up to 12 months) |
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| Secondary | Number of Participants With Change in Dose or Schedule of Sunitinib | Number of participants with change in dose or schedule of sunitinib at the specified time points were reported in this outcome measure. | Full analysis set included all eligible participants enrolled in the study, whatever the therapeutic strategy used during the observation period. | Posted | Count of Participants | Participants | Month 3, 6, 9 and 12 |
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| Secondary | Number of Participants With Dose Increase | Full analysis set included all eligible participants enrolled in the study, whatever the therapeutic strategy used during the observation period. | Posted | Count of Participants | Participants | During treatment period (up to 12 months) |
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| Secondary | Number of Participants With Temporary Interruption During the Sunitinib Treatment Period | Full analysis set included all eligible participants enrolled in the study, whatever the therapeutic strategy used during the observation period. | Posted | Count of Participants | Participants | During treatment period (up to 12 months) |
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| Secondary | Time to First Interruption | Full analysis set included all eligible participants enrolled in the study, whatever the therapeutic strategy used during the observation period. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | Median | Inter-Quartile Range | Days | During treatment period (up to 12 months) |
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| Secondary | Time to All Interruptions | Full analysis set included all eligible participants enrolled in the study, whatever the therapeutic strategy used during the observation period. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | Median | Inter-Quartile Range | Days | During treatment period (up to 12 months) |
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| Secondary | Number of Participants According to Reasons for Temporary Interruption | Number of participants according to reasons for temporary interruption (adverse events, logistical, personal and intolerant to sunitinib) at specified time points is presented in this outcome measure. | Full analysis set included all eligible participants enrolled in the study, whatever the therapeutic strategy used during the observation period. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable at the specified time points. | Posted | Count of Participants | Participants | Months 3, 6, 9 and 12 |
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| Secondary | Number of Participants With Sunitinib Discontinuation | Number of participants with sunitinib discontinuation at specified time points is presented in this outcome measure. | Full analysis set included all eligible participants enrolled in the study, whatever the therapeutic strategy used during the observation period. | Posted | Count of Participants | Participants | Months 3, 6, 9 and 12 |
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| Secondary | Number of Participants According to Reasons for Sunitinib Discontinuation | Number of participants according to reasons for sunitinib discontinuation (death, intolerability, progression) at specified time points is presented in this outcome measure. | Full analysis set included all eligible participants enrolled in the study, whatever the therapeutic strategy used during the observation period. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable at the specified time points. | Posted | Count of Participants | Participants | Months 3, 6, 9 and 12 |
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| Secondary | Median Duration of Sunitinib Treatment | Median duration of treatment was defined as the time between the sunitinib initiation and the sunitinib discontinuation date or the last follow-up date with sunitinib treatment. | Full analysis set included all eligible participants enrolled in the study, whatever the therapeutic strategy used during the observation period. | Posted | Median | Full Range | Days | From date of first dose of sunitinib until discontinuation or last follow-up date with sunitinib treatment (up to maximum of 36 months) |
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| Secondary | Combined Progression Free Survival | Combined PFS was defined as the time from when the participants received the first dose of sunitinib as first line, until progression or death due to any cause while on the 2nd line treatment, whichever occurred first during the 2nd line sequence treatment. As per RECIST version 1.1, disease progression was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of the longest dimensions of the target lesions taking as a reference smallest sum of the longest dimensions recorded since the treatment started, or the appearance of 1 or more new lesions. | Full analysis set included all eligible participants enrolled in the study, whatever the therapeutic strategy used during the observation period. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | Median | Inter-Quartile Range | Days | From date of first dose of sunitinib until progression or death whichever occurred first during second line treatment (up to maximum of 36 months) |
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| Secondary | Combined TTF for the Sunitinib-2nd Line Sequence | Combined TTF was defined as the time from when the participant received the first dose with sunitinib as first line, to the time of 2nd line sequence discontinuation (date completed by the physician). | Full analysis set included all eligible participants enrolled in the study, whatever the therapeutic strategy used during the observation period. | Posted | Median | Inter-Quartile Range | Days | From date of first dose of sunitinib until discontinuation of second line treatment (up to maximum of 36 months) |
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| Secondary | Combined PFS According to Type of Second Line Treatment | Combined PFS was defined as the time from when the participants received the first dose of sunitinib as first line, until progression or death due to any cause while on the 2nd line treatment, whichever occurred first during the 2nd line sequence treatment. As per RECIST version 1.1, disease progression was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of the longest dimensions of the target lesions taking as a reference smallest sum of the longest dimensions recorded since the treatment started, or the appearance of 1 or more new lesions. Combined PFS according to the type of second line treatment (best supportive care [BSC], tyrosine kinase inhibitors [TKI] including pazopanib and mammalian target of rapamycin [mTOR] inhibitors including everolimus) were reported in this outcome measure. | Full analysis set included all eligible participants enrolled in the study, whatever the therapeutic strategy used during the observation period. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable at the specified time points. | Posted | Median | Inter-Quartile Range | Days | From date of first dose of sunitinib until progression or death whichever occurred first during second line treatment (up to maximum of 36 months) |
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|
| Secondary | Overall Survival | Overall survival was defined as the time from date of first sunitinib dose to the date of death of any cause. | Full analysis set included all eligible participants enrolled in the study, whatever the therapeutic strategy used during the observation period. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | Median | Inter-Quartile Range | Days | From date of first dose of sunitinib to the date of death of any cause (up to maximum of 36 months) |
|
|
|
| Secondary | Number of Participants Experiencing At Least One Adverse Event (AE) of Any Grade | An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. AEs were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) as follows: Grade 1: mild AE, Grade 2: moderate AE, Grade 3: severe AE, Grade 4: life-threatening consequences and urgent intervention indicated, Grade 5: death related to AE. In this outcome measure, number of participants with at least one AE of any grade is reported. | Full analysis set included all eligible participants enrolled in the study, whatever the therapeutic strategy used during the observation period. | Posted | Count of Participants | Participants | From date of sunitinib first dose until end of follow-up (up to maximum of 36 months) |
|
|
|
| Secondary | Number of Most Common AEs of Any Grade by Preferred Term | An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. AEs were graded according to NCI-CTCAE as follows: Grade 1: mild AE, Grade 2: moderate AE, Grade 3: severe AE, Grade 4: life-threatening consequences and urgent intervention indicated, Grade 5: death related to AE. In this outcome measure, number of most common AEs of any grade is presented. Only events captured as deaths (preferred term) are reported as deaths in the data table. | Full analysis set included all eligible participants enrolled in the study, whatever the therapeutic strategy used during the observation period. | Posted | Number | Events | From date of sunitinib first dose until end of follow-up (up to maximum of 36 months) | Adverse events | Adverse events |
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|
|
| Secondary | Number of Events of Diarrhea, Hypertension, Fatigue, Asthenia, Palmar-plantar Erythrodysesthesia Syndrome, Nausea, Stomatitis, Neutropenia, Lymphopenia and Elevated Lipase | Number of events of diarrhea, hypertension, fatigue, asthenia, palmar-plantar erythrodysesthesia syndrome, nausea, stomatitis, neutropenia, lymphopenia and elevated lipase were reported in this outcome measure. | Full analysis set included all eligible participants enrolled in the study, whatever the therapeutic strategy used during the observation period. | Posted | Number | Events | From date of sunitinib first dose until end of follow-up (up to maximum of 36 months) | Adverse events | Adverse events |
|
|
|
| Secondary | Number of Participants With Serious Adverse Events and Non-Serious AEs | A serious adverse event was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) at any dose that: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect. In this outcome measure, number of participants with serious adverse events and non-serious adverse events are reported. | Full analysis set included all eligible participants enrolled in the study, whatever the therapeutic strategy used during the observation period. | Posted | Count of Participants | Participants | From date of sunitinib first dose until end of follow-up (up to maximum of 36 months) |
|
|
|
| Secondary | Number of Adverse Events According to Grade | An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. AEs were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) as follows: Grade 1: mild AE, Grade 2: moderate AE, Grade 3: severe AE, Grade 4: life-threatening consequences and urgent intervention indicated, Grade 5: death related to AE. | Full analysis set included all eligible participants enrolled in the study, whatever the therapeutic strategy used during the observation period. | Posted | Number | Events | From date of sunitinib first dose until end of follow-up (up to maximum of 36 months) | Adverse events | Adverse events |
|
|
|
| Secondary | Number of Participants Who Discontinued Treatment Due to AEs | An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. In this outcome measure, number of participants who discontinued treatment due to AEs are reported. | Full analysis set included all eligible participants enrolled in the study, whatever the therapeutic strategy used during the observation period. | Posted | Count of Participants | Participants | From date of sunitinib first dose until end of follow-up (up to maximum of 36 months) |
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|
|
| Secondary | Duration of Treatment Until Discontinuation for AEs | An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. | Full analysis set included all eligible participants enrolled in the study, whatever the therapeutic strategy used during the observation period. | Posted | Median | Inter-Quartile Range | Days | From date of sunitinib first dose until end of follow-up (up to maximum of 36 months) |
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|
|
| Secondary | Number of Participants Who Died Due to Any Cause | Full analysis set included all eligible participants enrolled in the study, whatever the therapeutic strategy used during the observation period. | Posted | Count of Participants | Participants | From date of sunitinib first dose until end of follow-up (up to maximum of 36 months) |
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|
|
| Secondary | Number of Participants According to the Cause of Death | Full analysis set included all eligible participants enrolled in the study, whatever the therapeutic strategy used during the observation period. | Posted | Count of Participants | Participants | From date of sunitinib first dose until end of follow-up (up to maximum of 36 months) |
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|
|
| Secondary | Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (FKSI-19) Total Scores | The FKSI-19 is a disease-specific instrument that assessed symptoms of importance in renal cancer participants. It consisted of 4 subscales (FKSI-Disease Related Symptoms [DRS]-Physical [P]-12 items, FKSI-DRS-Emotional [E]-1 item, treatment side effects [TSE]-3 items, functional wellbeing [FWB]-3 items). Participants were required to respond to a total of 19 questions regarding symptoms, side effects and wellbeing on a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). The total FKSI scores were calculated as the sum of the item responses divided by the number of items completed multiplied by the total number of items in the scale and ranged from 0 (severely symptomatic) to 76 (asymptomatic), where higher scores indicated better health. | Full analysis set included all eligible participants enrolled in the study, whatever the therapeutic strategy used during the observation period. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable at the specified time points. | Posted | Mean | Standard Deviation | Units on a scale | Day 0, Month 3, 6, 9, 12, 18 and 24 |
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| Secondary | Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (FKSI-19) Sub-scale Scores | The FKSI-19 is a disease-specific instrument that assessed symptoms of importance in renal cancer participants. It consisted of 4 subscales (FKSI-DRS-P: 12 items, FKSI-DRS-E: 1 item, TSE: 3 items, FWB: 3 items). Participants were required to respond to the items in each subscale on a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). The FKSI subscale scores were calculated as the sum of item responses divided by the number of items completed multiplied by the total number of items in the subscale and ranged from 0 (severely symptomatic) to 48 (asymptomatic) for FKSI-DRS-P, 0 (severely symptomatic) to 4 (asymptomatic) for FKSI-DRS-E and 0 (severely symptomatic) to 12 (asymptomatic) for TSE and FWB; higher scores indicated better health. | Full analysis set included all eligible participants enrolled in the study, whatever the therapeutic strategy used during the observation period. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable at the specified time points. | Posted | Mean | Standard Deviation | Units on a scale | Day 0, Month 3, 6, 9, 12, 18 and 24 |
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|
|
| 33 |
| 74 |
| 35 |
| 74 |
| 35 |
| 74 |
| Pain | General disorders | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Coma | Nervous system disorders | Non-systematic Assessment |
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| Hemorrhage intracranial | Nervous system disorders | Non-systematic Assessment |
|
| Brain stem stroke | Nervous system disorders | Non-systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Electrolyte imbalance | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Metabolic acidosis | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | Non-systematic Assessment |
|
| Hepatotoxicity | Hepatobiliary disorders | Non-systematic Assessment |
|
| Septic shock | Infections and infestations | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | Non-systematic Assessment |
|
| Hematuria | Renal and urinary disorders | Non-systematic Assessment |
|
| Nephropathy toxic | Renal and urinary disorders | Non-systematic Assessment |
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| Renal failure | Renal and urinary disorders | Non-systematic Assessment |
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| Renal impairment | Renal and urinary disorders | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | Non-systematic Assessment |
|
| Circulatory collapse | Vascular disorders | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Hematemesis | Gastrointestinal disorders | Non-systematic Assessment |
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| Hemorrhoids | Gastrointestinal disorders | Non-systematic Assessment |
|
| Mucosal inflammation | General disorders | Non-systematic Assessment |
|
| Asthenia | General disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Pain | General disorders | Non-systematic Assessment |
|
| Face oedema | General disorders | Non-systematic Assessment |
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| Inflammation | General disorders | Non-systematic Assessment |
|
| Palmar-plantar erythrodysesthesia syndrome | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Skin ulcer | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Decubitus ulcer | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Skin toxicity | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | Non-systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Hypoacusis | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | Non-systematic Assessment |
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| Vision blurred | Eye disorders | Non-systematic Assessment |
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| Hepatotoxicity | Hepatobiliary disorders | Non-systematic Assessment |
|
| Fungal infection | Infections and infestations | Non-systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Hypertriglyceridemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Seizure | Nervous system disorders | Non-systematic Assessment |
|
| Hematuria | Renal and urinary disorders | Non-systematic Assessment |
|
| Renal failure | Renal and urinary disorders | Non-systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | 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.
| 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 |
| D007211 |
| Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| Title | Measurements |
|---|
|
| Month 12 |
|
| 37.5 mg per day 4 weeks on and 2 weeks off |
|
| Title | Measurements |
|---|
|
| Month 12 |
|
| Personal |
|
| Intolerant to Sunitinib |
|
| Month 6 |
|
|
| Month 9 |
|
|
| Month 12 |
|
|
| Title | Measurements |
|---|
|
| Month 12 |
|
| Progression |
|
| Unknown/Missing |
|
| Month 6 |
|
|
| Month 9 |
|
|
| Month 12 |
|
|
|
| mTOR |
|
|
| Title | Measurements |
|---|
|
| Mucosal inflammation |
|
| Vomiting |
|
| Title | Measurements |
|---|
|
| Asthenia |
|
| Palmar-plantar erythrodysesthesia syndrome |
|
| Nausea |
|
| Stomatitis |
|
| Neutropenia |
|
| Lymphopenia |
|
| Elevated lipase |
|
| Title | Measurements |
|---|
|
| Grade 4 |
|
| Grade 5 |
|
|
| Month 6 |
|
|
| Month 9 |
|
|
| Month 12 |
|
|
| Month 18 |
|
|
| Month 24 |
|
|
|
| FKSI-DRS-P; Month 6 |
|
|
| FKSI-DRS-P; Month 9 |
|
|
| FKSI-DRS-P; Month 12 |
|
|
| FKSI-DRS-P; Month 18 |
|
|
| FKSI-DRS-P; Month 24 |
|
|
| FKSI-TSE; Day 0 |
|
|
| FKSI-TSE; Month 3 |
|
|
| FKSI-TSE; Month 6 |
|
|
| FKSI-TSE; Month 9 |
|
|
| FKSI-TSE; Month 12 |
|
|
| FKSI-TSE; Month 18 |
|
|
| FKSI-TSE; Month 24 |
|
|
| FKSI-FWB; Day 0 |
|
|
| FKSI-FWB; Month 3 |
|
|
| FKSI-FWB; Month 6 |
|
|
| FKSI-FWB; Month 9 |
|
|
| FKSI-FWB; Month 12 |
|
|
| FKSI-FWB; Month 18 |
|
|
| FKSI-FWB; Month 24 |
|
|