Trial Outcomes & Findings for Evaluation Of The Impact Of A Call Center In Management Of Metastatic And/Or Advanced Renal Cell Carcinoma Patients Treated With Sunitinib (Sutent) In First Line (NCT NCT02187042)

Last Updated: 2019-10-24

Results Overview

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. The severity was graded by NCI CTCAE v.4.03. Grade 1 was mild AE. Grade 2 was moderate AE. Grade 3 was severe AE. Grade 4 was life-threatening consequences and urgent intervention AE. Grade 5 was death related to AE.

Recruitment status

COMPLETED

Target enrollment

70 participants

Primary outcome timeframe

Baseline up to 6 months

Results posted on

2019-10-24

Participant Flow

Participant milestones

Participant milestones
Measure	Call Center Participants with advanced/metastatic renal cell carcinoma (a/mRCC) being treated first line with sunitinib (dose as per the recommendations in the summary or product characteristics \[SmPC\]) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks.	Standard of Care Participants with a/mRCC being treated first line with sunitinib (dose as per SmPC) were followed by conventional standard care method. Participants were monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. Each cycle was of at least 6 weeks.
Overall Study STARTED	42	27
Overall Study COMPLETED	29	13
Overall Study NOT COMPLETED	13	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Call Center Participants with advanced/metastatic renal cell carcinoma (a/mRCC) being treated first line with sunitinib (dose as per the recommendations in the summary or product characteristics \[SmPC\]) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks.	Standard of Care Participants with a/mRCC being treated first line with sunitinib (dose as per SmPC) were followed by conventional standard care method. Participants were monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. Each cycle was of at least 6 weeks.
Overall Study Death	1	1
Overall Study Toxicity	6	5
Overall Study Participant choice	1	0
Overall Study Doctor choice	1	0
Overall Study Progressive disease	4	8

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Call Center n=42 Participants Participants with a/mRCC being treated first line with sunitinib (dose as per the recommendations in the SmPC) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks.	Standard of Care n=27 Participants Participants with a/mRCC being treated first line with sunitinib (dose as per SmPC) were followed by conventional standard care method. Participants were monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. Each cycle was of at least 6 weeks.	Total n=69 Participants Total of all reporting groups
Age, Continuous	67.2 years STANDARD_DEVIATION 10.3 • n=42 Participants	65.6 years STANDARD_DEVIATION 9.2 • n=27 Participants	66.6 years STANDARD_DEVIATION 9.8 • n=69 Participants
Sex: Female, Male Female	12 Participants n=42 Participants	5 Participants n=27 Participants	17 Participants n=69 Participants
Sex: Female, Male Male	30 Participants n=42 Participants	22 Participants n=27 Participants	52 Participants n=69 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Baseline up to 6 months

Population: Safety population included participants treated with Sunitinib.

Outcome measures

Outcome measures
Measure	Call Center n=42 Participants Participants with a/mRCC being treated first line with sunitinib (dose as per the recommendations in the SmPC) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks.	Standard of Care n=27 Participants Participants with a/mRCC being treated first line with sunitinib (dose as per SmPC) were followed by conventional standard care method. Participants were monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. Each cycle was of at least 6 weeks.
Number of Participants With at Least 1 Adverse Event (AE) of Grade 3 or 4 Based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03	34 Participants	14 Participants

SECONDARY outcome

Timeframe: Baseline up to 6 months

Population: Safety population included participants treated with Sunitinib.

Number of participants treated with sunitinib having had at least 1 dose reduction relative to the initial dose are reported.

Outcome measures

Outcome measures
Measure	Call Center n=42 Participants Participants with a/mRCC being treated first line with sunitinib (dose as per the recommendations in the SmPC) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks.	Standard of Care n=27 Participants Participants with a/mRCC being treated first line with sunitinib (dose as per SmPC) were followed by conventional standard care method. Participants were monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. Each cycle was of at least 6 weeks.
Number of Participants With at Least 1 Sunitinib Dose Reduction	12 Participants	4 Participants

SECONDARY outcome

Timeframe: Baseline up to 6 months

Population: Safety population included participants treated with Sunitinib. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Number of participants treated with sunitinib having had at least 1 dose reduction relative to the initial dose according to the reasons for dose reductions are reported.

Outcome measures

Outcome measures
Measure	Call Center n=12 Participants Participants with a/mRCC being treated first line with sunitinib (dose as per the recommendations in the SmPC) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks.	Standard of Care n=4 Participants Participants with a/mRCC being treated first line with sunitinib (dose as per SmPC) were followed by conventional standard care method. Participants were monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. Each cycle was of at least 6 weeks.
Number of Participants Involved in at Least 1 Occasion For Each of the Reasons for a Sunitinib Dose Reduction Adverse Event	12 Participants	3 Participants
Number of Participants Involved in at Least 1 Occasion For Each of the Reasons for a Sunitinib Dose Reduction Unknown	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline up to 6 months

Population: Safety population included participants treated with Sunitinib. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Call Center n=12 Participants Participants with a/mRCC being treated first line with sunitinib (dose as per the recommendations in the SmPC) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks.	Standard of Care n=4 Participants Participants with a/mRCC being treated first line with sunitinib (dose as per SmPC) were followed by conventional standard care method. Participants were monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. Each cycle was of at least 6 weeks.
Average Sunitinib Dose Reduction	12.5 milligram per day (mg/day) Standard Deviation 0	12.5 milligram per day (mg/day) Standard Deviation 0

SECONDARY outcome

Timeframe: Baseline up to 6 months

Population: Safety population included participants treated with Sunitinib.

Reason for temporary dose interruptions included: who had AEs that were intolerable, surgery, omission, doctor choice and any other reason judged by doctor.

Outcome measures

Outcome measures
Measure	Call Center n=42 Participants Participants with a/mRCC being treated first line with sunitinib (dose as per the recommendations in the SmPC) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks.	Standard of Care n=27 Participants Participants with a/mRCC being treated first line with sunitinib (dose as per SmPC) were followed by conventional standard care method. Participants were monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. Each cycle was of at least 6 weeks.
Number of Participants With at Least 1 Temporary Interruption of Sunitinib Treatment	27 Participants	8 Participants

SECONDARY outcome

Timeframe: Baseline up to 6 months

Population: Safety population included participants treated with Sunitinib. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Reason for temporary dose interruptions included: who had AEs that were intolerable, surgery, omission, doctor choice and any other reason judged by doctor.

Outcome measures

Outcome measures
Measure	Call Center n=27 Participants Participants with a/mRCC being treated first line with sunitinib (dose as per the recommendations in the SmPC) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks.	Standard of Care n=8 Participants Participants with a/mRCC being treated first line with sunitinib (dose as per SmPC) were followed by conventional standard care method. Participants were monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. Each cycle was of at least 6 weeks.
Mean Duration (in Days) of Temporary Interruption to Sunitinib Treatment	10.5 days Standard Deviation 11.5	16.6 days Standard Deviation 19.4

SECONDARY outcome

Timeframe: Baseline up to 6 months

Population: Safety population included participants treated with Sunitinib. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Reason for temporary dose interruptions included: who had AEs that were intolerable, surgery, omission, doctor choice and any other reason judged by doctor. Participants were counted in more than 1 category.

Outcome measures

Outcome measures
Measure	Call Center n=27 Participants Participants with a/mRCC being treated first line with sunitinib (dose as per the recommendations in the SmPC) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks.	Standard of Care n=8 Participants Participants with a/mRCC being treated first line with sunitinib (dose as per SmPC) were followed by conventional standard care method. Participants were monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. Each cycle was of at least 6 weeks.
Number of Participants Involved on at Least 1 Occasion for Each of the Reasons for a Sunitinib Temporary Treatment Interruption AE	19 Participants	7 Participants
Number of Participants Involved on at Least 1 Occasion for Each of the Reasons for a Sunitinib Temporary Treatment Interruption Surgery	1 Participants	0 Participants
Number of Participants Involved on at Least 1 Occasion for Each of the Reasons for a Sunitinib Temporary Treatment Interruption Omission	4 Participants	0 Participants
Number of Participants Involved on at Least 1 Occasion for Each of the Reasons for a Sunitinib Temporary Treatment Interruption Doctor choice	6 Participants	1 Participants
Number of Participants Involved on at Least 1 Occasion for Each of the Reasons for a Sunitinib Temporary Treatment Interruption Other	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline up to 6 months

Population: Safety population included participants treated with Sunitinib.

Reason for permanent discontinuation of sunitinib treatment included: progressive disease, toxicity, participant's choice, doctor's choice and death of participant.

Outcome measures

Outcome measures
Measure	Call Center n=42 Participants Participants with a/mRCC being treated first line with sunitinib (dose as per the recommendations in the SmPC) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks.	Standard of Care n=27 Participants Participants with a/mRCC being treated first line with sunitinib (dose as per SmPC) were followed by conventional standard care method. Participants were monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. Each cycle was of at least 6 weeks.
Number of Participants Who Permanently Discontinued Sunitinib Treatment	13 Participants	14 Participants

SECONDARY outcome

Timeframe: Baseline up to 6 months

Population: Safety population included participants treated with Sunitinib. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Reason for permanent discontinuation of sunitinib treatment included: progressive disease, toxicity, participant's choice, doctor's choice and death of participant.

Outcome measures

Outcome measures
Measure	Call Center n=13 Participants Participants with a/mRCC being treated first line with sunitinib (dose as per the recommendations in the SmPC) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks.	Standard of Care n=14 Participants Participants with a/mRCC being treated first line with sunitinib (dose as per SmPC) were followed by conventional standard care method. Participants were monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. Each cycle was of at least 6 weeks.
Number of Participants Involved on At Least 1 Occasion for Each of the Reasons for a Permanent Sunitinib Treatment Discontinuation Progressive Disease	4 Participants	8 Participants
Number of Participants Involved on At Least 1 Occasion for Each of the Reasons for a Permanent Sunitinib Treatment Discontinuation Toxicity	6 Participants	5 Participants
Number of Participants Involved on At Least 1 Occasion for Each of the Reasons for a Permanent Sunitinib Treatment Discontinuation Participant Choice	1 Participants	0 Participants
Number of Participants Involved on At Least 1 Occasion for Each of the Reasons for a Permanent Sunitinib Treatment Discontinuation Doctor's Choice	1 Participants	0 Participants
Number of Participants Involved on At Least 1 Occasion for Each of the Reasons for a Permanent Sunitinib Treatment Discontinuation Death	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline up to 6 months

Population: Safety population included participants treated with Sunitinib.

Total mean duration (in months) of sunitinib treatment is reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Call Center n=42 Participants Participants with a/mRCC being treated first line with sunitinib (dose as per the recommendations in the SmPC) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks.	Standard of Care n=27 Participants Participants with a/mRCC being treated first line with sunitinib (dose as per SmPC) were followed by conventional standard care method. Participants were monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. Each cycle was of at least 6 weeks.
Mean Duration of Sunitinib Treatment	4.8 Months Standard Deviation 1.9	4.2 Months Standard Deviation 1.9

SECONDARY outcome

Timeframe: Baseline up to 6 months

Population: Safety population included participants treated with Sunitinib.

Last treatment cycle was declared by doctor either on the notified date to discontinue sunitinib or on the date of the last consultation if sunitinib treatment was not stopped

Outcome measures

Outcome measures
Measure	Call Center n=42 Participants Participants with a/mRCC being treated first line with sunitinib (dose as per the recommendations in the SmPC) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks.	Standard of Care n=27 Participants Participants with a/mRCC being treated first line with sunitinib (dose as per SmPC) were followed by conventional standard care method. Participants were monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. Each cycle was of at least 6 weeks.
Number of Participants Classified on the Basis of Number of Sunitinib Treatment Cycles 1 Cycle	6 Participants	3 Participants
Number of Participants Classified on the Basis of Number of Sunitinib Treatment Cycles 2 Cycles	1 Participants	7 Participants
Number of Participants Classified on the Basis of Number of Sunitinib Treatment Cycles 3 Cycles	7 Participants	5 Participants
Number of Participants Classified on the Basis of Number of Sunitinib Treatment Cycles 4 Cycles	28 Participants	12 Participants

SECONDARY outcome

Timeframe: Baseline up to 6 months

Population: Analysis population included participants who were treated with Sunitinib and had follow up by call center along with conventional method. Data was collected only for the reporting arm "call center" as per the planned analysis.

Number of participants with at least 1 unplanned hospitalizations either related or unrelated to sunitinib were reported.

Outcome measures

Outcome measures
Measure	Call Center n=42 Participants Participants with a/mRCC being treated first line with sunitinib (dose as per the recommendations in the SmPC) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks.	Standard of Care Participants with a/mRCC being treated first line with sunitinib (dose as per SmPC) were followed by conventional standard care method. Participants were monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. Each cycle was of at least 6 weeks.
Number of Participants With At Least 1 Unplanned Hospitalization	9 Participants	—

SECONDARY outcome

Timeframe: Baseline up to 6 months

Population: Analysis population included included participants who were treated with sunitinib and had follow up by call center along with conventional method. Data was collected only for the reporting arm "call center" as per the planned analysis.

Number of participants with at least 1 unplanned consultations either related or unrelated to sunitinib were reported.

Outcome measures

Outcome measures
Measure	Call Center n=42 Participants Participants with a/mRCC being treated first line with sunitinib (dose as per the recommendations in the SmPC) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks.	Standard of Care Participants with a/mRCC being treated first line with sunitinib (dose as per SmPC) were followed by conventional standard care method. Participants were monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. Each cycle was of at least 6 weeks.
Number of Participants With At Least 1 Unplanned Consultation	16 Participants	—

SECONDARY outcome

Timeframe: Baseline up to 6 months

Population: Safety population included participants treated with Sunitinib. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

MMAS-4 is a self-reported measure of medication taking behavior, consisting of 4 questions based on forgetting taking medication, carelessness about taking medication, stopping medication when feeling better, or stopping medication when feeling worse. Each question has answer either "Yes" or "No"; "Yes" =1 and "No" =0. The sum of answer to all 4 questions resulted in total MMAS-4 score. Total MMAS-4 score ranges from 0 (best adherence) to 4 (worst adherence), a low score representing improved adherence. Adherent participants were defined as participants with an MMAS-4 score of 0.

Outcome measures

Outcome measures
Measure	Call Center n=34 Participants Participants with a/mRCC being treated first line with sunitinib (dose as per the recommendations in the SmPC) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks.	Standard of Care n=18 Participants Participants with a/mRCC being treated first line with sunitinib (dose as per SmPC) were followed by conventional standard care method. Participants were monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. Each cycle was of at least 6 weeks.
Number of Participants Who Were "Adherent" as Per 4- Item Morisky Medication Adherence Scale (MMAS-4)	30 Participants	15 Participants

SECONDARY outcome

Timeframe: Baseline up to 6 months

Population: Safety population included participants treated with Sunitinib. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

MMAS-4 is a self-reported measure of medication taking behavior, consisting of 4 questions based on forgetting taking medication, carelessness about taking medication, stopping medication when feeling better, or stopping medication when feeling worse. Each question has answer either "Yes" or "No"; "Yes" =1 and "No" =0. The sum of answer to all 4 questions resulted in total MMAS-4 score. Total MMAS-4 score ranges from 0 (best adherence) to 4 (worst adherence), a low score representing improved adherence. High adherence: score of 0, average adherence: score of 1 or 2, poor adherence: score of 3 or 4.

Outcome measures

Outcome measures
Measure	Call Center n=34 Participants Participants with a/mRCC being treated first line with sunitinib (dose as per the recommendations in the SmPC) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks.	Standard of Care n=18 Participants Participants with a/mRCC being treated first line with sunitinib (dose as per SmPC) were followed by conventional standard care method. Participants were monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. Each cycle was of at least 6 weeks.
Mean 4-Item Morisky Medication Adherence Scale (MMAS-4) Score	0.1 Units on a scale Standard Deviation 0.5	0.2 Units on a scale Standard Deviation 0.4

SECONDARY outcome

Timeframe: Baseline up to 6 months

Population: Analysis population included all participants who were investigated by the doctors, who met the study eligibility criteria, had received at least 1 dose of Sunitinib and who had telephone calls with call center. Data was collected only for the reporting arm "call center" as per the planned analysis.

ORR used for the assessment of response to treatment. As per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1: Complete response (CR) was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than \[\<\] 10 millimetre \[mm\]). No new lesions. Partial response (PR) was defined as greater than or equal to (\>=) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.

Outcome measures

Outcome measures
Measure	Call Center n=39 Participants Participants with a/mRCC being treated first line with sunitinib (dose as per the recommendations in the SmPC) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks.	Standard of Care Participants with a/mRCC being treated first line with sunitinib (dose as per SmPC) were followed by conventional standard care method. Participants were monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. Each cycle was of at least 6 weeks.
Objective Response Rate (ORR): Percentage of Participants With a Complete or Partial Best Response	33.3 Percentage of participants	—

SECONDARY outcome

Timeframe: At the end of the study (At Month 6)

Population: Analysis population: participants who were investigated by the doctors, who met study eligibility criteria, had received at least 1 dose of Sunitinib and were followed up by call center and completed a self-administered satisfaction questionnaire about management by call center. Here, 'Number analyzed' = participants evaluable for specified rows.

Participants' satisfaction with call center was assessed via the self-administered questionnaire completed at the end of the study. Questionnaire evaluated 4 dimensions with total of 8 items. Dimensions were: 1) Satisfaction with advice: 3 item, 2) Satisfaction with care, 3) Satisfaction concerning the service: 3 items and 4) Overall satisfaction with support in management of sunitinib treatment: 1 item. Each item had 5 responses: very satisfied, satisfied, not very satisfied, not satisfied and no opinion equivalent to score of +2, +1, 1, -2 and no score respectively. A score was calculated for each dimension by calculating the mean scores obtained for each item if at least 50% of the items for the dimension had been completed (and are not "no opinion"). Overall possible mean score range for each dimension was +2 to -2, where higher scores signified higher satisfaction.

Outcome measures

Outcome measures
Measure	Call Center n=22 Participants Participants with a/mRCC being treated first line with sunitinib (dose as per the recommendations in the SmPC) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks.	Standard of Care Participants with a/mRCC being treated first line with sunitinib (dose as per SmPC) were followed by conventional standard care method. Participants were monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. Each cycle was of at least 6 weeks.
Mean Scores for Each Dimension on the Participant's Satisfaction (With the Management By the Telephone Call Center) Questionnaire Satisfaction with the advice	1.2 Units on a scale Standard Deviation 0.9	—
Mean Scores for Each Dimension on the Participant's Satisfaction (With the Management By the Telephone Call Center) Questionnaire Satisfaction with care	1.1 Units on a scale Standard Deviation 1.1	—
Mean Scores for Each Dimension on the Participant's Satisfaction (With the Management By the Telephone Call Center) Questionnaire Satisfaction with the service	1.2 Units on a scale Standard Deviation 0.9	—
Mean Scores for Each Dimension on the Participant's Satisfaction (With the Management By the Telephone Call Center) Questionnaire Overall satisfaction with support in management	1.2 Units on a scale Standard Deviation 0.9	—

SECONDARY outcome

Timeframe: At the end of the study (At Month 6)

Population: Analysis population included all participants who were investigated by the doctors, who met the study eligibility criteria, had received at least 1 dose of Sunitinib and who were followed up by call center and completed a self-administered satisfaction questionnaire about management by call center.

Participants' satisfaction with call center was assessed via the self-administered questionnaire completed at the end of the study. Questionnaire evaluated 4 dimensions with total of 8 items. Dimensions were: 1) Satisfaction concerning advice: have 3 item, 2) Satisfaction concerning management: 1 items, 3) Satisfaction concerning the service: 3 items and 4) Overall satisfaction with support in management of sunitinib treatment: 1 item. Each item had 5 responses: very satisfied, satisfied, not very satisfied, not satisfied and no opinion. In this outcome measure number of participants who were either "Satisfied" or "Very Satisfied" for overall satisfaction were reported.

Outcome measures

Outcome measures
Measure	Call Center n=22 Participants Participants with a/mRCC being treated first line with sunitinib (dose as per the recommendations in the SmPC) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks.	Standard of Care Participants with a/mRCC being treated first line with sunitinib (dose as per SmPC) were followed by conventional standard care method. Participants were monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. Each cycle was of at least 6 weeks.
Number of Participants Who Reported Themselves Being "Satisfied" or "Very Satisfied" With the Management By the Telephone Call Center	19 Participants	—

SECONDARY outcome

Timeframe: At the end of the study (At Month 6)

Population: Analysis population included all investigating doctors/physicians who completed a satisfaction questionnaire to assess the management of follow-up of participants by the call center. For this outcome measure 'Participant' refers to 'investigating physician'.

Physician's satisfaction with call center service for participants' follow-up was assessed via the self-administered questionnaire completed at the end of the study. Questionnaire evaluated 3 dimensions with total of 5 items. Dimensions were: 1) Satisfaction concerning advice: had 3 items, 2) Satisfaction concerning management: 1 items and 3) Overall satisfaction: 1 item. Each item had 5 responses: very satisfied, satisfied, not very satisfied, not satisfied and no opinion equivalent to score of +2, +1, 1, -2 and no score respectively. A score was calculated for each dimension by calculating the mean scores obtained for each item if at least 50% of the items for the dimension have been completed (and are not "no opinion"). Overall possible mean score range for each dimension was +2 to -2, where higher scores signified higher satisfaction.

Outcome measures

Outcome measures
Measure	Call Center n=12 Participants Participants with a/mRCC being treated first line with sunitinib (dose as per the recommendations in the SmPC) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks.	Standard of Care Participants with a/mRCC being treated first line with sunitinib (dose as per SmPC) were followed by conventional standard care method. Participants were monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. Each cycle was of at least 6 weeks.
Mean Scores for Each Dimension on the Physician's Satisfaction (With the Management By the Telephone Call Center) Questionnaire Satisfaction with the advice	0.4 Units on a scale Standard Deviation 1.1	—
Mean Scores for Each Dimension on the Physician's Satisfaction (With the Management By the Telephone Call Center) Questionnaire Satisfaction with care	-0.6 Units on a scale Standard Deviation 1.2	—
Mean Scores for Each Dimension on the Physician's Satisfaction (With the Management By the Telephone Call Center) Questionnaire Overall satisfaction of participant care	0.1 Units on a scale Standard Deviation 1.4	—

SECONDARY outcome

Timeframe: Baseline up to 6 months

Physicians' satisfaction with call center service for participants' follow-up was assessed via the self-administered questionnaire completed at the end of the study. Questionnaire evaluated 3 dimensions with total of 5 item. Dimensions were: 1) Satisfaction concerning advice: had 3 items, 2) Satisfaction concerning management: 1 items and 3) Overall satisfaction: 1 item. Each item had 5 responses: very satisfied, satisfied, not very satisfied, not satisfied and no opinion. In this outcome measure number of physicians who were either "Satisfied" or "Very Satisfied" for overall satisfaction were reported.

Outcome measures

Outcome measures
Measure	Call Center n=12 Participants Participants with a/mRCC being treated first line with sunitinib (dose as per the recommendations in the SmPC) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks.	Standard of Care Participants with a/mRCC being treated first line with sunitinib (dose as per SmPC) were followed by conventional standard care method. Participants were monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. Each cycle was of at least 6 weeks.
Number of Investigating Physicians Who Reported Themselves Being "Satisfied" or "Very Satisfied" With the Management By the Telephone Call Center	7 Physicians	—

SECONDARY outcome

Timeframe: Baseline up to 6 months

Population: Analysis population included all participants who were investigated by the doctors, who met the study eligibility criteria, had received at least 1 dose of Sunitinib and who had telephone calls with call center. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

1 participant can call more than once during the study.

Outcome measures

Outcome measures
Measure	Call Center n=35 Participants Participants with a/mRCC being treated first line with sunitinib (dose as per the recommendations in the SmPC) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks.	Standard of Care Participants with a/mRCC being treated first line with sunitinib (dose as per SmPC) were followed by conventional standard care method. Participants were monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. Each cycle was of at least 6 weeks.
Total Number of Calls (Planned and Unplanned)	431 Calls	—

SECONDARY outcome

Timeframe: First call made anytime from baseline up to 6 months

Population: Analysis population included all participants who were investigated by the doctors, who met the study eligibility criteria, had received at least 1 dose of Sunitinib and who had telephone calls with call center. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Participants were followed up for taking their medication and they were supposed to respond either "yes" or "no". In this outcome measure participants who responded "Yes" are reported.

Outcome measures

Outcome measures
Measure	Call Center n=35 Participants Participants with a/mRCC being treated first line with sunitinib (dose as per the recommendations in the SmPC) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks.	Standard of Care Participants with a/mRCC being treated first line with sunitinib (dose as per SmPC) were followed by conventional standard care method. Participants were monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. Each cycle was of at least 6 weeks.
Number of Participants Who Were Taking Sunitinib as Told to Call Center During the First Call	33 Participants	—

SECONDARY outcome

Timeframe: First call made anytime from baseline up to 6 months

Population: Analysis population included all participants who were investigated by the doctors, who met the study eligibility criteria, had received at least 1 dose of Sunitinib and who had telephone calls with call center. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Actions of investigating doctors/physicians: did doctor clearly explained how to take treatment, were participants given documentation about treatment by doctor or medical team, did doctor explained how to manage any side effects due to treatment which could occur and were prescriptions or orders for supportive medical treatments given by doctor. Participants responded either "Yes" or "No". In this outcome measure participants who responded "Yes" to each action are reported.

Outcome measures

Outcome measures
Measure	Call Center n=35 Participants Participants with a/mRCC being treated first line with sunitinib (dose as per the recommendations in the SmPC) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks.	Standard of Care Participants with a/mRCC being treated first line with sunitinib (dose as per SmPC) were followed by conventional standard care method. Participants were monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. Each cycle was of at least 6 weeks.
Number of Participants With Their Responses as "Yes" Against the Actions of Investigating Physicians, as Told to Call Center During the First Call Doctor clearly explained how to take treatment	31 Participants	—
Number of Participants With Their Responses as "Yes" Against the Actions of Investigating Physicians, as Told to Call Center During the First Call Participants given documentation about treatment	31 Participants	—
Number of Participants With Their Responses as "Yes" Against the Actions of Investigating Physicians, as Told to Call Center During the First Call Doctor explain manage side effect due to treatment	27 Participants	—
Number of Participants With Their Responses as "Yes" Against the Actions of Investigating Physicians, as Told to Call Center During the First Call Prescriptions for supportive medical treatments	27 Participants	—

SECONDARY outcome

Timeframe: Baseline up to 6 months

Population: Analysis population included all participants who were investigated by the doctors, who met the study eligibility criteria, had received at least 1 dose of Sunitinib and who had telephone calls with call center. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

In this outcome measure number of telephone calls against each action taken/or described by the call center to the participants are reported. Actions taken by the call center included: 1) Given advice about managing the treatment: a) advice about taking Sunitinib, b) advice about using the Sunitinib follow-up diary, c) reporting any AE; 2) Given general preventative advice: a) advice about taking preventative systemic treatments, b) lifestyle advice, c) food/dietetic advice, d) oro-dental hygiene advice; 3) Given specific preventative advice for a type of AE: a) prevention of skin toxicities, b) prevention of gastrointestinal disorders, c) prevention of cardiac disorders, d) prevention of infectious/inflammatory problems, e)other preventative advice; 4) Actions recommended to participant: a) do not forget the planned consultation with the oncologist, b) get the additional investigations requested performed.

Outcome measures

Outcome measures
Measure	Call Center n=431 Telephone calls Participants with a/mRCC being treated first line with sunitinib (dose as per the recommendations in the SmPC) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks.	Standard of Care Participants with a/mRCC being treated first line with sunitinib (dose as per SmPC) were followed by conventional standard care method. Participants were monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. Each cycle was of at least 6 weeks.
Number of Telephone Calls Describing Actions Taken by Call Center Advice about managing treatment: taking Sunitinib	266 Telephone calls	—
Number of Telephone Calls Describing Actions Taken by Call Center Advice about managing treatment:Sunitinib followup	281 Telephone calls	—
Number of Telephone Calls Describing Actions Taken by Call Center Advice about managing treatment: Reporting any AE	341 Telephone calls	—
Number of Telephone Calls Describing Actions Taken by Call Center General preventative advice: taking treatments	263 Telephone calls	—
Number of Telephone Calls Describing Actions Taken by Call Center General preventative advice: Lifestyle advice	278 Telephone calls	—
Number of Telephone Calls Describing Actions Taken by Call Center General preventative advice: Food/dietetic advice	222 Telephone calls	—
Number of Telephone Calls Describing Actions Taken by Call Center General preventative advice: Orodental hygiene	272 Telephone calls	—
Number of Telephone Calls Describing Actions Taken by Call Center Specific advice for type of AE: skin toxicities	270 Telephone calls	—
Number of Telephone Calls Describing Actions Taken by Call Center Specific advice for type of AE: GI disorders	271 Telephone calls	—
Number of Telephone Calls Describing Actions Taken by Call Center Specific advice for type of AE: cardiac disorders	317 Telephone calls	—
Number of Telephone Calls Describing Actions Taken by Call Center Specific advice for type of AE: infectious problem	233 Telephone calls	—
Number of Telephone Calls Describing Actions Taken by Call Center Specific advice for type of AE:preventative advice	289 Telephone calls	—
Number of Telephone Calls Describing Actions Taken by Call Center Actions to participants:Do not forget consultation	134 Telephone calls	—
Number of Telephone Calls Describing Actions Taken by Call Center Actions to participants: additional investigation	137 Telephone calls	—

SECONDARY outcome

Timeframe: Baseline up to 6 months

Population: Call center full analysis set (FAS) population included all participants who were investigated by doctors, who met the study eligibility criteria and had received at least 1 dose of Sunitinib and were followed up by call center. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

In this outcome measure total number of telephone calls where participants declared of any AE are reported. Participants could call more than once to declare AE.

Outcome measures

Outcome measures
Measure	Call Center n=431 Telephone calls Participants with a/mRCC being treated first line with sunitinib (dose as per the recommendations in the SmPC) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks.	Standard of Care Participants with a/mRCC being treated first line with sunitinib (dose as per SmPC) were followed by conventional standard care method. Participants were monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. Each cycle was of at least 6 weeks.
Number of Telephone Calls Where Participants Declared Adverse Events	280 Telephone calls	—

Adverse Events

Call Center

Serious events: 12 serious events

Other events: 42 other events

Deaths: 2 deaths

Standard of Care

Serious events: 15 serious events

Other events: 27 other events

Deaths: 3 deaths

Serious adverse events

Other adverse events

Additional Information

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Phone: 1-800-718-1021

Email: [email protected]

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