Metastatic Renal Cell Carcinoma
Conditions
Keywords
Sunitinib, Metastatic Renal Cell Carcinoma, Africa Middle East
Brief summary
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.
Detailed description
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
Interventions
DRUGSunitinib
Sunitinib is an FDA approved targeted therapy for use as first line therapy for patients with metastatic renal cell carcinoma.
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Inclusion Criteria: 1. Patients being treated with SU as 1st line treatment according to the approved therapeutic indication. 2. Histologically confirmed diagnosis of mRCC (clear cell RCC as well as nonclear cell RCC) with measurable disease according to RECIST 1.1 3. 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
<!-- --> 1. Patients being treated with cytokines or any other treatment other than SU in 1st line setting 2. Patients presenting with a known hypersensitivity to SU or its metabolites will not be included in the study per the label.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | 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) | 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. |
| Time to Treatment Failure (TTF) | From date of first dose of sunitinib until the date of discontinuation or censored date (up to maximum of 36 months) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Recommended Starting Dose of Sunitinib | At initiation of sunitinib (Day 0) | The recommended starting dose of sunitinib was 50 milligrams (mg) per day, 4 weeks on treatment followed by 2 weeks off. |
| Number of Participants With Other Starting Doses | At initiation of sunitinib (Day 0) | 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. |
| 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 | During treatment period (up to 12 months) | 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). |
| Number of Participants With Change in Dose or Schedule of Sunitinib | Month 3, 6, 9 and 12 | Number of participants with change in dose or schedule of sunitinib at the specified time points were reported in this outcome measure. |
| 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 | Months 3, 6, 9 and 12 | 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. |
| Number of Participants With Sunitinib Discontinuation | Months 3, 6, 9 and 12 | Number of participants with sunitinib discontinuation at specified time points is presented in this outcome measure. |
| Number of Participants According to Reasons for Sunitinib Discontinuation | Months 3, 6, 9 and 12 | Number of participants according to reasons for sunitinib discontinuation (death, intolerability, progression) at specified time points is presented in this outcome measure. |
| Median Duration of 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) | 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. |
| 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) | — |
| 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) | — |
| Combined Progression Free Survival | 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 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 TTF for the Sunitinib-2nd Line Sequence | From date of first dose of sunitinib until discontinuation of second line treatment (up to maximum of 36 months) | 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). |
| Combined PFS According to Type of Second Line Treatment | 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 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. |
| Overall Survival | From date of first dose of sunitinib to the date of death of any cause (up to maximum of 36 months) | Overall survival was defined as the time from date of first sunitinib dose to the date of death of any cause. |
| Number of Participants Experiencing At Least One Adverse Event (AE) of Any Grade | From date of sunitinib first dose until end of follow-up (up to maximum of 36 months) | 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. |
| Number of Most Common AEs of Any Grade by Preferred Term | From date of sunitinib first dose until end of follow-up (up to maximum of 36 months) | 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. |
| Number of Events of Diarrhea, Hypertension, Fatigue, Asthenia, Palmar-plantar Erythrodysesthesia Syndrome, Nausea, Stomatitis, Neutropenia, Lymphopenia and Elevated Lipase | 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 were reported in this outcome measure. |
| Number of Participants With Serious Adverse Events and Non-Serious AEs | From date of sunitinib first dose until end of follow-up (up to maximum of 36 months) | 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. |
| Number of Adverse Events According to Grade | From date of sunitinib first dose until end of follow-up (up to maximum of 36 months) | 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. |
| Number of Participants Who Discontinued Treatment Due to AEs | From date of sunitinib first dose until end of follow-up (up to maximum of 36 months) | 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. |
| Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (FKSI-19) Total Scores | Day 0, Month 3, 6, 9, 12, 18 and 24 | 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. |
| Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (FKSI-19) Sub-scale Scores | Day 0, Month 3, 6, 9, 12, 18 and 24 | 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. |
| Duration of Treatment Until Discontinuation for AEs | From date of sunitinib first dose until end of follow-up (up to maximum of 36 months) | 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. |
| Objective Response Rate (ORR) at Months 3, 6, 9 and 12 | 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. |
Countries
Algeria, Egypt, Kuwait, Morocco
Participant flow
Recruitment details
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.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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. | 74 |
| Total | 74 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 33 |
| Overall Study | Disease progression | 1 |
| Overall Study | Lost to Follow-up | 15 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Reason missing | 23 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Sunitinib |
|---|---|
| Age, Continuous | 53.5 Years STANDARD_DEVIATION 13.6 |
| Race/Ethnicity, Customized Asian | 2 Participants |
| Race/Ethnicity, Customized Black/ African Descent | 2 Participants |
| Race/Ethnicity, Customized Caucasian | 18 Participants |
| Race/Ethnicity, Customized Middle Eastern | 45 Participants |
| Race/Ethnicity, Customized Unknown | 7 Participants |
| Sex: Female, Male Female | 36 Participants |
| Sex: Female, Male Male | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 33 / 74 |
| other Total, other adverse events | 35 / 74 |
| serious Total, serious adverse events | 35 / 74 |
Outcome results
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.
Time frame: 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)
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sunitinib | Progression Free Survival (PFS) | 321.0 Days |
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.
Time frame: From date of first dose of sunitinib until the date of discontinuation or censored date (up to maximum of 36 months)
Population: Full analysis set included all eligible participants enrolled in the study, whatever the therapeutic strategy used during the observation period.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sunitinib | Time to Treatment Failure (TTF) | 348.0 Days |
Secondary
Average Dose Received Over the Sunitinib Treatment Period
Time frame: During treatment period (up to 12 months)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sunitinib | Average Dose Received Over the Sunitinib Treatment Period | 7917.1 Milligrams | Standard Deviation 6834.5 |
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.
Time frame: From date of first dose of sunitinib until progression or death whichever occurred first during second line treatment (up to maximum of 36 months)
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Sunitinib | Combined PFS According to Type of Second Line Treatment | mTOR | 399.0 Days |
| Sunitinib | Combined PFS According to Type of Second Line Treatment | BSC | 169.0 Days |
| Sunitinib | Combined PFS According to Type of Second Line Treatment | TKI | 948.0 Days |
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.
Time frame: From date of first dose of sunitinib until progression or death whichever occurred first during second line treatment (up to maximum of 36 months)
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sunitinib | Combined Progression Free Survival | 502.0 Days |
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).
Time frame: From date of first dose of sunitinib until discontinuation of second line treatment (up to maximum of 36 months)
Population: Full analysis set included all eligible participants enrolled in the study, whatever the therapeutic strategy used during the observation period.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sunitinib | Combined TTF for the Sunitinib-2nd Line Sequence | 378.0 Days |
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).
Time frame: During treatment period (up to 12 months)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sunitinib | Dose Intensity of Sunitinib | 48.5 Milligrams per day | Standard Deviation 5.1 |
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.
Time frame: From date of sunitinib first dose until end of follow-up (up to maximum of 36 months)
Population: Full analysis set included all eligible participants enrolled in the study, whatever the therapeutic strategy used during the observation period.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sunitinib | Duration of Treatment Until Discontinuation for AEs | 572 Days |
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.
Time frame: Day 0, Month 3, 6, 9, 12, 18 and 24
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sunitinib | Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (FKSI-19) Sub-scale Scores | FKSI-DRS-P; Month 24 | 37 Units on a scale | Standard Deviation 6.6 |
| Sunitinib | Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (FKSI-19) Sub-scale Scores | FKSI-TSE; Day 0 | 10.3 Units on a scale | Standard Deviation 1.6 |
| Sunitinib | Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (FKSI-19) Sub-scale Scores | FKSI-TSE; Month 18 | 10.3 Units on a scale | Standard Deviation 1.4 |
| Sunitinib | Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (FKSI-19) Sub-scale Scores | FKSI-FWB; Month 6 | 6.3 Units on a scale | Standard Deviation 3.5 |
| Sunitinib | Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (FKSI-19) Sub-scale Scores | FKSI-DRS-P; Day 0 | 31.9 Units on a scale | Standard Deviation 8.8 |
| Sunitinib | Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (FKSI-19) Sub-scale Scores | FKSI-DRS-P; Month 3 | 33.2 Units on a scale | Standard Deviation 9.1 |
| Sunitinib | Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (FKSI-19) Sub-scale Scores | FKSI-DRS-P; Month 6 | 37.6 Units on a scale | Standard Deviation 7.1 |
| Sunitinib | Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (FKSI-19) Sub-scale Scores | FKSI-DRS-P; Month 9 | 34.7 Units on a scale | Standard Deviation 8.9 |
| Sunitinib | Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (FKSI-19) Sub-scale Scores | FKSI-DRS-P; Month 12 | 35.6 Units on a scale | Standard Deviation 9.2 |
| Sunitinib | Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (FKSI-19) Sub-scale Scores | FKSI-DRS-P; Month 18 | 34.6 Units on a scale | Standard Deviation 6.3 |
| Sunitinib | Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (FKSI-19) Sub-scale Scores | FKSI-TSE; Month 3 | 9.6 Units on a scale | Standard Deviation 2.1 |
| Sunitinib | Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (FKSI-19) Sub-scale Scores | FKSI-TSE; Month 6 | 9.8 Units on a scale | Standard Deviation 1.4 |
| Sunitinib | Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (FKSI-19) Sub-scale Scores | FKSI-TSE; Month 9 | 8.8 Units on a scale | Standard Deviation 2.7 |
| Sunitinib | Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (FKSI-19) Sub-scale Scores | FKSI-TSE; Month 12 | 9.7 Units on a scale | Standard Deviation 2.7 |
| Sunitinib | Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (FKSI-19) Sub-scale Scores | FKSI-TSE; Month 24 | 11 Units on a scale | Standard Deviation 1.2 |
| Sunitinib | Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (FKSI-19) Sub-scale Scores | FKSI-FWB; Day 0 | 6.3 Units on a scale | Standard Deviation 3.5 |
| Sunitinib | Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (FKSI-19) Sub-scale Scores | FKSI-FWB; Month 3 | 5.0 Units on a scale | Standard Deviation 3.7 |
| Sunitinib | Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (FKSI-19) Sub-scale Scores | FKSI-FWB; Month 9 | 5.8 Units on a scale | Standard Deviation 3.8 |
| Sunitinib | Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (FKSI-19) Sub-scale Scores | FKSI-FWB; Month 12 | 6.4 Units on a scale | Standard Deviation 3.6 |
| Sunitinib | Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (FKSI-19) Sub-scale Scores | FKSI-FWB; Month 18 | 5.9 Units on a scale | Standard Deviation 3.4 |
| Sunitinib | Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (FKSI-19) Sub-scale Scores | FKSI-FWB; Month 24 | 5.2 Units on a scale | Standard Deviation 3.4 |
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.
Time frame: Day 0, Month 3, 6, 9, 12, 18 and 24
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sunitinib | Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (FKSI-19) Total Scores | Day 0 | 50.6 Units on a scale | Standard Deviation 12.4 |
| Sunitinib | Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (FKSI-19) Total Scores | Month 3 | 49.8 Units on a scale | Standard Deviation 13.9 |
| Sunitinib | Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (FKSI-19) Total Scores | Month 6 | 56.1 Units on a scale | Standard Deviation 11 |
| Sunitinib | Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (FKSI-19) Total Scores | Month 9 | 51.6 Units on a scale | Standard Deviation 14.5 |
| Sunitinib | Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (FKSI-19) Total Scores | Month 12 | 54.1 Units on a scale | Standard Deviation 15.4 |
| Sunitinib | Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (FKSI-19) Total Scores | Month 18 | 53.3 Units on a scale | Standard Deviation 9.4 |
| Sunitinib | Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (FKSI-19) Total Scores | Month 24 | 55.2 Units on a scale | Standard Deviation 9.6 |
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.
Time frame: From date of first dose of sunitinib until discontinuation or last follow-up date with sunitinib treatment (up to maximum of 36 months)
Population: Full analysis set included all eligible participants enrolled in the study, whatever the therapeutic strategy used during the observation period.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sunitinib | Median Duration of Sunitinib Treatment | 169.5 Days |
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.
Time frame: From date of sunitinib first dose until end of follow-up (up to maximum of 36 months)
Population: Full analysis set included all eligible participants enrolled in the study, whatever the therapeutic strategy used during the observation period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sunitinib | Number of Adverse Events According to Grade | Grade 1 | 35 Events |
| Sunitinib | Number of Adverse Events According to Grade | Grade 2 | 38 Events |
| Sunitinib | Number of Adverse Events According to Grade | Grade 3 | 32 Events |
| Sunitinib | Number of Adverse Events According to Grade | Grade 4 | 23 Events |
| Sunitinib | Number of Adverse Events According to Grade | Grade 5 | 22 Events |
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.
Time frame: From date of sunitinib first dose until end of follow-up (up to maximum of 36 months)
Population: Full analysis set included all eligible participants enrolled in the study, whatever the therapeutic strategy used during the observation period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sunitinib | Number of Events of Diarrhea, Hypertension, Fatigue, Asthenia, Palmar-plantar Erythrodysesthesia Syndrome, Nausea, Stomatitis, Neutropenia, Lymphopenia and Elevated Lipase | Diarrhea | 8 Events |
| Sunitinib | Number of Events of Diarrhea, Hypertension, Fatigue, Asthenia, Palmar-plantar Erythrodysesthesia Syndrome, Nausea, Stomatitis, Neutropenia, Lymphopenia and Elevated Lipase | Hypertension | 2 Events |
| Sunitinib | Number of Events of Diarrhea, Hypertension, Fatigue, Asthenia, Palmar-plantar Erythrodysesthesia Syndrome, Nausea, Stomatitis, Neutropenia, Lymphopenia and Elevated Lipase | Fatigue | 4 Events |
| Sunitinib | Number of Events of Diarrhea, Hypertension, Fatigue, Asthenia, Palmar-plantar Erythrodysesthesia Syndrome, Nausea, Stomatitis, Neutropenia, Lymphopenia and Elevated Lipase | Asthenia | 4 Events |
| Sunitinib | Number of Events of Diarrhea, Hypertension, Fatigue, Asthenia, Palmar-plantar Erythrodysesthesia Syndrome, Nausea, Stomatitis, Neutropenia, Lymphopenia and Elevated Lipase | Palmar-plantar erythrodysesthesia syndrome | 6 Events |
| Sunitinib | Number of Events of Diarrhea, Hypertension, Fatigue, Asthenia, Palmar-plantar Erythrodysesthesia Syndrome, Nausea, Stomatitis, Neutropenia, Lymphopenia and Elevated Lipase | Nausea | 2 Events |
| Sunitinib | Number of Events of Diarrhea, Hypertension, Fatigue, Asthenia, Palmar-plantar Erythrodysesthesia Syndrome, Nausea, Stomatitis, Neutropenia, Lymphopenia and Elevated Lipase | Stomatitis | 3 Events |
| Sunitinib | Number of Events of Diarrhea, Hypertension, Fatigue, Asthenia, Palmar-plantar Erythrodysesthesia Syndrome, Nausea, Stomatitis, Neutropenia, Lymphopenia and Elevated Lipase | Neutropenia | 1 Events |
| Sunitinib | Number of Events of Diarrhea, Hypertension, Fatigue, Asthenia, Palmar-plantar Erythrodysesthesia Syndrome, Nausea, Stomatitis, Neutropenia, Lymphopenia and Elevated Lipase | Lymphopenia | 0 Events |
| Sunitinib | Number of Events of Diarrhea, Hypertension, Fatigue, Asthenia, Palmar-plantar Erythrodysesthesia Syndrome, Nausea, Stomatitis, Neutropenia, Lymphopenia and Elevated Lipase | Elevated lipase | 0 Events |
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.
Time frame: From date of sunitinib first dose until end of follow-up (up to maximum of 36 months)
Population: Full analysis set included all eligible participants enrolled in the study, whatever the therapeutic strategy used during the observation period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sunitinib | Number of Most Common AEs of Any Grade by Preferred Term | Death | 19 Events |
| Sunitinib | Number of Most Common AEs of Any Grade by Preferred Term | Anemia | 8 Events |
| Sunitinib | Number of Most Common AEs of Any Grade by Preferred Term | Diarrhea | 8 Events |
| Sunitinib | Number of Most Common AEs of Any Grade by Preferred Term | Mucosal inflammation | 8 Events |
| Sunitinib | Number of Most Common AEs of Any Grade by Preferred Term | Vomiting | 8 Events |
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.
Time frame: Months 3, 6, 9 and 12
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Sunitinib | Number of Participants According to Reasons for Sunitinib Discontinuation | Month 6 | Progression | 3 Participants |
| Sunitinib | Number of Participants According to Reasons for Sunitinib Discontinuation | Month 6 | Unknown/Missing | 0 Participants |
| Sunitinib | Number of Participants According to Reasons for Sunitinib Discontinuation | Month 9 | Death | 0 Participants |
| Sunitinib | Number of Participants According to Reasons for Sunitinib Discontinuation | Month 12 | Progression | 5 Participants |
| Sunitinib | Number of Participants According to Reasons for Sunitinib Discontinuation | Month 3 | Death | 1 Participants |
| Sunitinib | Number of Participants According to Reasons for Sunitinib Discontinuation | Month 3 | Intolerability | 4 Participants |
| Sunitinib | Number of Participants According to Reasons for Sunitinib Discontinuation | Month 3 | Progression | 10 Participants |
| Sunitinib | Number of Participants According to Reasons for Sunitinib Discontinuation | Month 3 | Unknown/Missing | 0 Participants |
| Sunitinib | Number of Participants According to Reasons for Sunitinib Discontinuation | Month 6 | Death | 0 Participants |
| Sunitinib | Number of Participants According to Reasons for Sunitinib Discontinuation | Month 6 | Intolerability | 1 Participants |
| Sunitinib | Number of Participants According to Reasons for Sunitinib Discontinuation | Month 9 | Intolerability | 1 Participants |
| Sunitinib | Number of Participants According to Reasons for Sunitinib Discontinuation | Month 9 | Progression | 2 Participants |
| Sunitinib | Number of Participants According to Reasons for Sunitinib Discontinuation | Month 9 | Unknown/Missing | 1 Participants |
| Sunitinib | Number of Participants According to Reasons for Sunitinib Discontinuation | Month 12 | Death | 0 Participants |
| Sunitinib | Number of Participants According to Reasons for Sunitinib Discontinuation | Month 12 | Intolerability | 1 Participants |
| Sunitinib | Number of Participants According to Reasons for Sunitinib Discontinuation | Month 12 | Unknown/Missing | 0 Participants |
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.
Time frame: Months 3, 6, 9 and 12
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Sunitinib | Number of Participants According to Reasons for Temporary Interruption | Month 3 | Adverse events | 5 Participants |
| Sunitinib | Number of Participants According to Reasons for Temporary Interruption | Month 3 | Logistical | 1 Participants |
| Sunitinib | Number of Participants According to Reasons for Temporary Interruption | Month 3 | Personal | 1 Participants |
| Sunitinib | Number of Participants According to Reasons for Temporary Interruption | Month 3 | Intolerant to Sunitinib | 1 Participants |
| Sunitinib | Number of Participants According to Reasons for Temporary Interruption | Month 6 | Adverse events | 3 Participants |
| Sunitinib | Number of Participants According to Reasons for Temporary Interruption | Month 6 | Logistical | 0 Participants |
| Sunitinib | Number of Participants According to Reasons for Temporary Interruption | Month 6 | Personal | 0 Participants |
| Sunitinib | Number of Participants According to Reasons for Temporary Interruption | Month 6 | Intolerant to Sunitinib | 0 Participants |
| Sunitinib | Number of Participants According to Reasons for Temporary Interruption | Month 9 | Adverse events | 1 Participants |
| Sunitinib | Number of Participants According to Reasons for Temporary Interruption | Month 9 | Logistical | 0 Participants |
| Sunitinib | Number of Participants According to Reasons for Temporary Interruption | Month 9 | Personal | 0 Participants |
| Sunitinib | Number of Participants According to Reasons for Temporary Interruption | Month 9 | Intolerant to Sunitinib | 0 Participants |
| Sunitinib | Number of Participants According to Reasons for Temporary Interruption | Month 12 | Adverse events | 3 Participants |
| Sunitinib | Number of Participants According to Reasons for Temporary Interruption | Month 12 | Logistical | 0 Participants |
| Sunitinib | Number of Participants According to Reasons for Temporary Interruption | Month 12 | Personal | 0 Participants |
| Sunitinib | Number of Participants According to Reasons for Temporary Interruption | Month 12 | Intolerant to Sunitinib | 0 Participants |
Secondary
Number of Participants According to the Cause of Death
Time frame: From date of sunitinib first dose until end of follow-up (up to maximum of 36 months)
Population: Full analysis set included all eligible participants enrolled in the study, whatever the therapeutic strategy used during the observation period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sunitinib | Number of Participants According to the Cause of Death | Other cause | 11 Participants |
| Sunitinib | Number of Participants According to the Cause of Death | Tumor-related | 22 Participants |
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.
Time frame: From date of sunitinib first dose until end of follow-up (up to maximum of 36 months)
Population: Full analysis set included all eligible participants enrolled in the study, whatever the therapeutic strategy used during the observation period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sunitinib | Number of Participants Experiencing At Least One Adverse Event (AE) of Any Grade | 51 Participants |
Secondary
Number of Participants Who Died Due to Any Cause
Time frame: From date of sunitinib first dose until end of follow-up (up to maximum of 36 months)
Population: Full analysis set included all eligible participants enrolled in the study, whatever the therapeutic strategy used during the observation period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sunitinib | Number of Participants Who Died Due to Any Cause | 33 Participants |
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.
Time frame: From date of sunitinib first dose until end of follow-up (up to maximum of 36 months)
Population: Full analysis set included all eligible participants enrolled in the study, whatever the therapeutic strategy used during the observation period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sunitinib | Number of Participants Who Discontinued Treatment Due to AEs | 20 Participants |
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.
Time frame: Month 3, 6, 9 and 12
Population: Full analysis set included all eligible participants enrolled in the study, whatever the therapeutic strategy used during the observation period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sunitinib | Number of Participants With Change in Dose or Schedule of Sunitinib | Month 3 | 7 Participants |
| Sunitinib | Number of Participants With Change in Dose or Schedule of Sunitinib | Month 6 | 3 Participants |
| Sunitinib | Number of Participants With Change in Dose or Schedule of Sunitinib | Month 9 | 2 Participants |
| Sunitinib | Number of Participants With Change in Dose or Schedule of Sunitinib | Month 12 | 0 Participants |
Secondary
Number of Participants With Dose Increase
Time frame: During treatment period (up to 12 months)
Population: Full analysis set included all eligible participants enrolled in the study, whatever the therapeutic strategy used during the observation period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sunitinib | Number of Participants With Dose Increase | 0 Participants |
Secondary
Number of Participants With Moderate Chronic Liver Failure, With 2 Milligrams (mg) Twice Daily (BID) as Starting Dose
Time frame: At initiation of sunitinib (Day 0)
Population: Full analysis set included all eligible participants enrolled in the study, whatever the therapeutic strategy used during the observation period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sunitinib | Number of Participants With Moderate Chronic Liver Failure, With 2 Milligrams (mg) Twice Daily (BID) as Starting Dose | 0 Participants |
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.
Time frame: At initiation of sunitinib (Day 0)
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sunitinib | Number of Participants With Other Starting Doses | 25 mg per day for 2 weeks on and 1 week off | 1 Participants |
| Sunitinib | Number of Participants With Other Starting Doses | 50 mg per day, 2 weeks on, 1 week off | 41 Participants |
| Sunitinib | Number of Participants With Other Starting Doses | 37.5 mg per day for 2 weeks on and 1 week off | 2 Participants |
| Sunitinib | Number of Participants With Other Starting Doses | 37.5 mg per day 4 weeks on and 2 weeks off | 1 Participants |
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.
Time frame: At initiation of sunitinib (Day 0)
Population: Full analysis set included all eligible participants enrolled in the study, whatever the therapeutic strategy used during the observation period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sunitinib | Number of Participants With Recommended Starting Dose of Sunitinib | 29 Participants |
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.
Time frame: From date of sunitinib first dose until end of follow-up (up to maximum of 36 months)
Population: Full analysis set included all eligible participants enrolled in the study, whatever the therapeutic strategy used during the observation period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sunitinib | Number of Participants With Serious Adverse Events and Non-Serious AEs | Serious adverse events | 35 Participants |
| Sunitinib | Number of Participants With Serious Adverse Events and Non-Serious AEs | Non-serious AEs | 35 Participants |
Secondary
Number of Participants With Sunitinib Discontinuation
Number of participants with sunitinib discontinuation at specified time points is presented in this outcome measure.
Time frame: Months 3, 6, 9 and 12
Population: Full analysis set included all eligible participants enrolled in the study, whatever the therapeutic strategy used during the observation period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sunitinib | Number of Participants With Sunitinib Discontinuation | Month 3 | 15 Participants |
| Sunitinib | Number of Participants With Sunitinib Discontinuation | Month 6 | 4 Participants |
| Sunitinib | Number of Participants With Sunitinib Discontinuation | Month 9 | 4 Participants |
| Sunitinib | Number of Participants With Sunitinib Discontinuation | Month 12 | 6 Participants |
Secondary
Number of Participants With Temporary Interruption During the Sunitinib Treatment Period
Time frame: During treatment period (up to 12 months)
Population: Full analysis set included all eligible participants enrolled in the study, whatever the therapeutic strategy used during the observation period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sunitinib | Number of Participants With Temporary Interruption During the Sunitinib Treatment Period | 15 Participants |
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.
Time frame: Months 3, 6, 9 and 12
Population: Full analysis set included all eligible participants enrolled in the study, whatever the therapeutic strategy used during the observation period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sunitinib | Objective Response Rate (ORR) at Months 3, 6, 9 and 12 | Month 6 | 9.5 Percentage of participants |
| Sunitinib | Objective Response Rate (ORR) at Months 3, 6, 9 and 12 | Month 3 | 17.6 Percentage of participants |
| Sunitinib | Objective Response Rate (ORR) at Months 3, 6, 9 and 12 | Month 9 | 8.1 Percentage of participants |
| Sunitinib | Objective Response Rate (ORR) at Months 3, 6, 9 and 12 | Month 12 | 2.7 Percentage of participants |
Secondary
Overall Survival
Overall survival was defined as the time from date of first sunitinib dose to the date of death of any cause.
Time frame: From date of first dose of sunitinib to the date of death of any cause (up to maximum of 36 months)
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sunitinib | Overall Survival | 544.0 Days |
Secondary
Time to All Interruptions
Time frame: During treatment period (up to 12 months)
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sunitinib | Time to All Interruptions | 109.0 Days |
Secondary
Time to First Interruption
Time frame: During treatment period (up to 12 months)
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sunitinib | Time to First Interruption | 130.0 Days |