Trial Outcomes & Findings for Real-world Clinical Patterns Of Care And Outcomes Among AfME mRCC Patients Receiving Sunitinib as First Line Therapy. (NCT NCT03140176)
NCT ID: NCT03140176
Last Updated: 2024-05-10
Results Overview
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.
TERMINATED
77 participants
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)
2024-05-10
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
74
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
74
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Reason missing
|
23
|
|
Overall Study
Death
|
33
|
|
Overall Study
Disease progression
|
1
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Lost to Follow-up
|
15
|
Baseline Characteristics
Real-world Clinical Patterns Of Care And Outcomes Among AfME mRCC Patients Receiving Sunitinib as First Line Therapy.
Baseline characteristics by cohort
| Measure |
Sunitinib
n=74 Participants
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.
|
|---|---|
|
Age, Continuous
|
53.5 Years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/ African Descent
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Middle Eastern
|
45 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Sunitinib
n=70 Participants
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.
|
|---|---|
|
Progression Free Survival (PFS)
|
321.0 Days
Interval 115.0 to 546.0
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Sunitinib
n=74 Participants
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.
|
|---|---|
|
Time to Treatment Failure (TTF)
|
348.0 Days
Interval 109.0 to 546.0
|
SECONDARY outcome
Timeframe: Months 3, 6, 9 and 12Population: Full analysis set included all eligible participants enrolled in the study, whatever the therapeutic strategy used during the observation period.
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.
Outcome measures
| Measure |
Sunitinib
n=74 Participants
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.
|
|---|---|
|
Objective Response Rate (ORR) at Months 3, 6, 9 and 12
Month 3
|
17.6 Percentage of participants
|
|
Objective Response Rate (ORR) at Months 3, 6, 9 and 12
Month 6
|
9.5 Percentage of participants
|
|
Objective Response Rate (ORR) at Months 3, 6, 9 and 12
Month 9
|
8.1 Percentage of participants
|
|
Objective Response Rate (ORR) at Months 3, 6, 9 and 12
Month 12
|
2.7 Percentage of participants
|
SECONDARY outcome
Timeframe: 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.
The recommended starting dose of sunitinib was 50 milligrams (mg) per day, 4 weeks on treatment followed by 2 weeks off.
Outcome measures
| Measure |
Sunitinib
n=74 Participants
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.
|
|---|---|
|
Number of Participants With Recommended Starting Dose of Sunitinib
|
29 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Sunitinib
n=45 Participants
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.
|
|---|---|
|
Number of Participants With Other Starting Doses
50 mg per day, 2 weeks on, 1 week off
|
41 Participants
|
|
Number of Participants With Other Starting Doses
37.5 mg per day for 2 weeks on and 1 week off
|
2 Participants
|
|
Number of Participants With Other Starting Doses
25 mg per day for 2 weeks on and 1 week off
|
1 Participants
|
|
Number of Participants With Other Starting Doses
37.5 mg per day 4 weeks on and 2 weeks off
|
1 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Sunitinib
n=74 Participants
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.
|
|---|---|
|
Number of Participants With Moderate Chronic Liver Failure, With 2 Milligrams (mg) Twice Daily (BID) as Starting Dose
|
0 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Sunitinib
n=67 Participants
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.
|
|---|---|
|
Average Dose Received Over the Sunitinib Treatment Period
|
7917.1 Milligrams
Standard Deviation 6834.5
|
SECONDARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Sunitinib
n=67 Participants
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.
|
|---|---|
|
Dose Intensity of Sunitinib
|
48.5 Milligrams per day
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: Month 3, 6, 9 and 12Population: Full analysis set included all eligible participants enrolled in the study, whatever the therapeutic strategy used during the observation period.
Number of participants with change in dose or schedule of sunitinib at the specified time points were reported in this outcome measure.
Outcome measures
| Measure |
Sunitinib
n=74 Participants
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.
|
|---|---|
|
Number of Participants With Change in Dose or Schedule of Sunitinib
Month 3
|
7 Participants
|
|
Number of Participants With Change in Dose or Schedule of Sunitinib
Month 6
|
3 Participants
|
|
Number of Participants With Change in Dose or Schedule of Sunitinib
Month 9
|
2 Participants
|
|
Number of Participants With Change in Dose or Schedule of Sunitinib
Month 12
|
0 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Sunitinib
n=74 Participants
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.
|
|---|---|
|
Number of Participants With Dose Increase
|
0 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Sunitinib
n=74 Participants
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.
|
|---|---|
|
Number of Participants With Temporary Interruption During the Sunitinib Treatment Period
|
15 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Sunitinib
n=15 Participants
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.
|
|---|---|
|
Time to First Interruption
|
130.0 Days
Interval 49.0 to 252.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Sunitinib
n=15 Participants
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.
|
|---|---|
|
Time to All Interruptions
|
109.0 Days
Interval 49.0 to 253.0
|
SECONDARY outcome
Timeframe: Months 3, 6, 9 and 12Population: 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.
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.
Outcome measures
| Measure |
Sunitinib
n=15 Participants
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.
|
|---|---|
|
Number of Participants According to Reasons for Temporary Interruption
Month 3 · Adverse events
|
5 Participants
|
|
Number of Participants According to Reasons for Temporary Interruption
Month 3 · Logistical
|
1 Participants
|
|
Number of Participants According to Reasons for Temporary Interruption
Month 3 · Personal
|
1 Participants
|
|
Number of Participants According to Reasons for Temporary Interruption
Month 3 · Intolerant to Sunitinib
|
1 Participants
|
|
Number of Participants According to Reasons for Temporary Interruption
Month 6 · Adverse events
|
3 Participants
|
|
Number of Participants According to Reasons for Temporary Interruption
Month 6 · Logistical
|
0 Participants
|
|
Number of Participants According to Reasons for Temporary Interruption
Month 6 · Personal
|
0 Participants
|
|
Number of Participants According to Reasons for Temporary Interruption
Month 6 · Intolerant to Sunitinib
|
0 Participants
|
|
Number of Participants According to Reasons for Temporary Interruption
Month 9 · Adverse events
|
1 Participants
|
|
Number of Participants According to Reasons for Temporary Interruption
Month 9 · Logistical
|
0 Participants
|
|
Number of Participants According to Reasons for Temporary Interruption
Month 9 · Personal
|
0 Participants
|
|
Number of Participants According to Reasons for Temporary Interruption
Month 9 · Intolerant to Sunitinib
|
0 Participants
|
|
Number of Participants According to Reasons for Temporary Interruption
Month 12 · Adverse events
|
3 Participants
|
|
Number of Participants According to Reasons for Temporary Interruption
Month 12 · Logistical
|
0 Participants
|
|
Number of Participants According to Reasons for Temporary Interruption
Month 12 · Personal
|
0 Participants
|
|
Number of Participants According to Reasons for Temporary Interruption
Month 12 · Intolerant to Sunitinib
|
0 Participants
|
SECONDARY outcome
Timeframe: Months 3, 6, 9 and 12Population: Full analysis set included all eligible participants enrolled in the study, whatever the therapeutic strategy used during the observation period.
Number of participants with sunitinib discontinuation at specified time points is presented in this outcome measure.
Outcome measures
| Measure |
Sunitinib
n=74 Participants
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.
|
|---|---|
|
Number of Participants With Sunitinib Discontinuation
Month 3
|
15 Participants
|
|
Number of Participants With Sunitinib Discontinuation
Month 6
|
4 Participants
|
|
Number of Participants With Sunitinib Discontinuation
Month 9
|
4 Participants
|
|
Number of Participants With Sunitinib Discontinuation
Month 12
|
6 Participants
|
SECONDARY outcome
Timeframe: Months 3, 6, 9 and 12Population: 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.
Number of participants according to reasons for sunitinib discontinuation (death, intolerability, progression) at specified time points is presented in this outcome measure.
Outcome measures
| Measure |
Sunitinib
n=29 Participants
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.
|
|---|---|
|
Number of Participants According to Reasons for Sunitinib Discontinuation
Month 9 · Death
|
0 Participants
|
|
Number of Participants According to Reasons for Sunitinib Discontinuation
Month 3 · Death
|
1 Participants
|
|
Number of Participants According to Reasons for Sunitinib Discontinuation
Month 3 · Intolerability
|
4 Participants
|
|
Number of Participants According to Reasons for Sunitinib Discontinuation
Month 3 · Progression
|
10 Participants
|
|
Number of Participants According to Reasons for Sunitinib Discontinuation
Month 3 · Unknown/Missing
|
0 Participants
|
|
Number of Participants According to Reasons for Sunitinib Discontinuation
Month 6 · Death
|
0 Participants
|
|
Number of Participants According to Reasons for Sunitinib Discontinuation
Month 6 · Intolerability
|
1 Participants
|
|
Number of Participants According to Reasons for Sunitinib Discontinuation
Month 6 · Progression
|
3 Participants
|
|
Number of Participants According to Reasons for Sunitinib Discontinuation
Month 6 · Unknown/Missing
|
0 Participants
|
|
Number of Participants According to Reasons for Sunitinib Discontinuation
Month 9 · Intolerability
|
1 Participants
|
|
Number of Participants According to Reasons for Sunitinib Discontinuation
Month 9 · Progression
|
2 Participants
|
|
Number of Participants According to Reasons for Sunitinib Discontinuation
Month 9 · Unknown/Missing
|
1 Participants
|
|
Number of Participants According to Reasons for Sunitinib Discontinuation
Month 12 · Death
|
0 Participants
|
|
Number of Participants According to Reasons for Sunitinib Discontinuation
Month 12 · Intolerability
|
1 Participants
|
|
Number of Participants According to Reasons for Sunitinib Discontinuation
Month 12 · Progression
|
5 Participants
|
|
Number of Participants According to Reasons for Sunitinib Discontinuation
Month 12 · Unknown/Missing
|
0 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Sunitinib
n=74 Participants
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.
|
|---|---|
|
Median Duration of Sunitinib Treatment
|
169.5 Days
Interval 87.0 to 362.0
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Sunitinib
n=70 Participants
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.
|
|---|---|
|
Combined Progression Free Survival
|
502.0 Days
Interval 215.0 to 660.0
|
SECONDARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Sunitinib
n=74 Participants
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.
|
|---|---|
|
Combined TTF for the Sunitinib-2nd Line Sequence
|
378.0 Days
Interval 146.0 to 793.0
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Sunitinib
n=28 Participants
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.
|
|---|---|
|
Combined PFS According to Type of Second Line Treatment
BSC
|
169.0 Days
Interval 144.0 to 539.0
|
|
Combined PFS According to Type of Second Line Treatment
TKI
|
948.0 Days
Interval 435.0 to 1095.0
|
|
Combined PFS According to Type of Second Line Treatment
mTOR
|
399.0 Days
Interval 215.0 to 399.0
|
SECONDARY outcome
Timeframe: 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.
Overall survival was defined as the time from date of first sunitinib dose to the date of death of any cause.
Outcome measures
| Measure |
Sunitinib
n=70 Participants
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.
|
|---|---|
|
Overall Survival
|
544.0 Days
Interval 146.0 to 794.0
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Sunitinib
n=74 Participants
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.
|
|---|---|
|
Number of Participants Experiencing At Least One Adverse Event (AE) of Any Grade
|
51 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Sunitinib
n=150 Adverse events
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.
|
|---|---|
|
Number of Most Common AEs of Any Grade by Preferred Term
Death
|
19 Events
|
|
Number of Most Common AEs of Any Grade by Preferred Term
Anemia
|
8 Events
|
|
Number of Most Common AEs of Any Grade by Preferred Term
Diarrhea
|
8 Events
|
|
Number of Most Common AEs of Any Grade by Preferred Term
Mucosal inflammation
|
8 Events
|
|
Number of Most Common AEs of Any Grade by Preferred Term
Vomiting
|
8 Events
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Sunitinib
n=150 Adverse events
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.
|
|---|---|
|
Number of Events of Diarrhea, Hypertension, Fatigue, Asthenia, Palmar-plantar Erythrodysesthesia Syndrome, Nausea, Stomatitis, Neutropenia, Lymphopenia and Elevated Lipase
Diarrhea
|
8 Events
|
|
Number of Events of Diarrhea, Hypertension, Fatigue, Asthenia, Palmar-plantar Erythrodysesthesia Syndrome, Nausea, Stomatitis, Neutropenia, Lymphopenia and Elevated Lipase
Hypertension
|
2 Events
|
|
Number of Events of Diarrhea, Hypertension, Fatigue, Asthenia, Palmar-plantar Erythrodysesthesia Syndrome, Nausea, Stomatitis, Neutropenia, Lymphopenia and Elevated Lipase
Fatigue
|
4 Events
|
|
Number of Events of Diarrhea, Hypertension, Fatigue, Asthenia, Palmar-plantar Erythrodysesthesia Syndrome, Nausea, Stomatitis, Neutropenia, Lymphopenia and Elevated Lipase
Asthenia
|
4 Events
|
|
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
|
|
Number of Events of Diarrhea, Hypertension, Fatigue, Asthenia, Palmar-plantar Erythrodysesthesia Syndrome, Nausea, Stomatitis, Neutropenia, Lymphopenia and Elevated Lipase
Nausea
|
2 Events
|
|
Number of Events of Diarrhea, Hypertension, Fatigue, Asthenia, Palmar-plantar Erythrodysesthesia Syndrome, Nausea, Stomatitis, Neutropenia, Lymphopenia and Elevated Lipase
Stomatitis
|
3 Events
|
|
Number of Events of Diarrhea, Hypertension, Fatigue, Asthenia, Palmar-plantar Erythrodysesthesia Syndrome, Nausea, Stomatitis, Neutropenia, Lymphopenia and Elevated Lipase
Neutropenia
|
1 Events
|
|
Number of Events of Diarrhea, Hypertension, Fatigue, Asthenia, Palmar-plantar Erythrodysesthesia Syndrome, Nausea, Stomatitis, Neutropenia, Lymphopenia and Elevated Lipase
Lymphopenia
|
0 Events
|
|
Number of Events of Diarrhea, Hypertension, Fatigue, Asthenia, Palmar-plantar Erythrodysesthesia Syndrome, Nausea, Stomatitis, Neutropenia, Lymphopenia and Elevated Lipase
Elevated lipase
|
0 Events
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Sunitinib
n=74 Participants
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.
|
|---|---|
|
Number of Participants With Serious Adverse Events and Non-Serious AEs
Serious adverse events
|
35 Participants
|
|
Number of Participants With Serious Adverse Events and Non-Serious AEs
Non-serious AEs
|
35 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Sunitinib
n=150 Adverse events
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.
|
|---|---|
|
Number of Adverse Events According to Grade
Grade 1
|
35 Events
|
|
Number of Adverse Events According to Grade
Grade 2
|
38 Events
|
|
Number of Adverse Events According to Grade
Grade 3
|
32 Events
|
|
Number of Adverse Events According to Grade
Grade 4
|
23 Events
|
|
Number of Adverse Events According to Grade
Grade 5
|
22 Events
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Sunitinib
n=74 Participants
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.
|
|---|---|
|
Number of Participants Who Discontinued Treatment Due to AEs
|
20 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Sunitinib
n=20 Participants
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.
|
|---|---|
|
Duration of Treatment Until Discontinuation for AEs
|
572 Days
Interval 201.0 to 1079.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Sunitinib
n=74 Participants
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.
|
|---|---|
|
Number of Participants Who Died Due to Any Cause
|
33 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Sunitinib
n=33 Participants
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.
|
|---|---|
|
Number of Participants According to the Cause of Death
Other cause
|
11 Participants
|
|
Number of Participants According to the Cause of Death
Tumor-related
|
22 Participants
|
SECONDARY outcome
Timeframe: Day 0, Month 3, 6, 9, 12, 18 and 24Population: 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.
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.
Outcome measures
| Measure |
Sunitinib
n=68 Participants
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.
|
|---|---|
|
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
|
|
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
|
|
Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (FKSI-19) Total Scores
Month 6
|
56.1 Units on a scale
Standard Deviation 11.0
|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: Day 0, Month 3, 6, 9, 12, 18 and 24Population: 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.
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.
Outcome measures
| Measure |
Sunitinib
n=68 Participants
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.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
Adverse Events
Sunitinib
Serious adverse events
| Measure |
Sunitinib
n=74 participants at risk
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.
|
|---|---|
|
General disorders
Death
|
25.7%
19/74 • 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.
|
|
General disorders
Pain
|
1.4%
1/74 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.1%
3/74 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.4%
1/74 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.4%
1/74 • 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.
|
|
Nervous system disorders
Coma
|
5.4%
4/74 • 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.
|
|
Nervous system disorders
Hemorrhage intracranial
|
2.7%
2/74 • 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.
|
|
Nervous system disorders
Brain stem stroke
|
1.4%
1/74 • 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.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.1%
3/74 • 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.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.7%
2/74 • 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.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
2.7%
2/74 • 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.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.4%
1/74 • 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.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
1.4%
1/74 • 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.
|
|
Blood and lymphatic system disorders
Anemia
|
2.7%
2/74 • 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.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.4%
1/74 • 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.
|
|
Gastrointestinal disorders
Vomiting
|
2.7%
2/74 • 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.
|
|
Hepatobiliary disorders
Hepatic failure
|
2.7%
2/74 • 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.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
2.7%
2/74 • 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.
|
|
Infections and infestations
Septic shock
|
1.4%
1/74 • 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.
|
|
Infections and infestations
Pneumonia
|
1.4%
1/74 • 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.
|
|
Renal and urinary disorders
Hematuria
|
1.4%
1/74 • 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.
|
|
Renal and urinary disorders
Nephropathy toxic
|
1.4%
1/74 • 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.
|
|
Renal and urinary disorders
Renal failure
|
1.4%
1/74 • 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.
|
|
Renal and urinary disorders
Renal impairment
|
1.4%
1/74 • 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.
|
|
Vascular disorders
Hypotension
|
2.7%
2/74 • 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.
|
|
Vascular disorders
Circulatory collapse
|
1.4%
1/74 • 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.
|
|
Vascular disorders
Hypertension
|
1.4%
1/74 • 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.
|
Other adverse events
| Measure |
Sunitinib
n=74 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
10.8%
8/74 • 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.
|
|
Gastrointestinal disorders
Vomiting
|
8.1%
6/74 • 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.
|
|
Gastrointestinal disorders
Stomatitis
|
4.1%
3/74 • 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.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.7%
2/74 • 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.
|
|
Gastrointestinal disorders
Nausea
|
2.7%
2/74 • 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.
|
|
Gastrointestinal disorders
Constipation
|
1.4%
1/74 • 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.
|
|
Gastrointestinal disorders
Hematemesis
|
1.4%
1/74 • 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.
|
|
Gastrointestinal disorders
Hemorrhoids
|
1.4%
1/74 • 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.
|
|
General disorders
Mucosal inflammation
|
10.8%
8/74 • 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.
|
|
General disorders
Asthenia
|
5.4%
4/74 • 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.
|
|
General disorders
Fatigue
|
5.4%
4/74 • 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.
|
|
General disorders
Pain
|
2.7%
2/74 • 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.
|
|
General disorders
Face oedema
|
1.4%
1/74 • 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.
|
|
General disorders
Inflammation
|
1.4%
1/74 • 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.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
8.1%
6/74 • 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.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
6.8%
5/74 • 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.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
1.4%
1/74 • 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.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.4%
1/74 • 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.
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
1.4%
1/74 • 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.
|
|
Blood and lymphatic system disorders
Anemia
|
8.1%
6/74 • 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.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.1%
3/74 • 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.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.4%
1/74 • 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.
|
|
Endocrine disorders
Hypothyroidism
|
6.8%
5/74 • 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.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.7%
2/74 • 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.
|
|
Ear and labyrinth disorders
Hypoacusis
|
1.4%
1/74 • 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.
|
|
Ear and labyrinth disorders
Tinnitus
|
1.4%
1/74 • 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.
|
|
Eye disorders
Vision blurred
|
1.4%
1/74 • 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.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
1.4%
1/74 • 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.
|
|
Infections and infestations
Fungal infection
|
1.4%
1/74 • 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.
|
|
Infections and infestations
Lower respiratory tract infection
|
1.4%
1/74 • 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.
|
|
Infections and infestations
Pneumonia
|
1.4%
1/74 • 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.
|
|
Infections and infestations
Urinary tract infection
|
1.4%
1/74 • 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.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
1.4%
1/74 • 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.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
1.4%
1/74 • 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.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.4%
1/74 • 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.
|
|
Nervous system disorders
Headache
|
1.4%
1/74 • 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.
|
|
Nervous system disorders
Seizure
|
1.4%
1/74 • 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.
|
|
Renal and urinary disorders
Hematuria
|
1.4%
1/74 • 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.
|
|
Renal and urinary disorders
Renal failure
|
1.4%
1/74 • 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.
|
|
Renal and urinary disorders
Renal impairment
|
1.4%
1/74 • 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.
|
|
Vascular disorders
Hypertension
|
1.4%
1/74 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER