Prospective Observational Analysis Of CR With Sunitinib Treatment In mRCC Patients

CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<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).

Time frame: From complete remission (before inclusion in the study, participants recruited for 3 years) till discontinuation of additional treatment during this study; [post inclusion follow-up in the study was maximum of 39.8 months for Cases]

Population: Analysis population included all eligible participants whose data were observed in the study. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.

In this outcome measure, duration of temporary discontinuation of sunitinib treatment were reported.

Time frame: Month 12 follow-up study visit

Population: Analysis population included all eligible participants whose data were observed in the study and who had attended at least Month 12 follow-up visit. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.

CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<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).

Time frame: Sunitinib initiation (before inclusion, participants recruited for 3 years) till progression (follow up period maximum of 39.8 months for Cases)

Population: Analysis population included all eligible participants whose data were observed in the study and who had attended at least end of study visit follow up. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.

In this outcome measure, duration of treatment with sunitinib since complete remission was reported.

Time frame: Month 12 follow-up study visit

Population: Analysis population included all eligible participants whose data were observed in the study and who had attended at least Month 12 follow-up visit. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.

CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<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).

Time frame: Month 24 follow-up study visit

Population: Analysis population included all eligible participants whose data were observed in the study and who had attended at least Month 24 follow-up visit. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.

An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.

Time frame: During follow up period maximum of 39.8 months for Cases and 37 months for Controls

Population: Analysis population included all eligible participants whose data were observed in the study. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure.

Time frame: Month 24 follow-up study visit

Population: Analysis population included all eligible participants whose data were observed in the study and who had attended at least Month 24 follow-up visit. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.

In this outcome measure, number of instances when different types of reasons led to temporary discontinuations like intolerance, local treatment and other reasons were reported. Participant could have temporarily discontinued sunitinib treatment more than once.

Time frame: Month 12 follow-up study visit

Population: Analysis population included all eligible participants whose data were observed in the study and who had attended at least Month 12 follow-up visit. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.

In this outcome measure, number of instances when participants resumed sunitinib treatment were reported. Participant could have temporarily discontinued sunitinib treatment more than once and likewise resumed treatment more than once.

Time frame: Month 12 follow-up study visit

Population: Analysis population included all eligible participants whose data were observed in the study and who had attended at least Month 12 follow-up visit. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.

In this outcome measure, median of metastatic sites were reported.

Time frame: At initiation of sunitinib (at Initiation Visit)

Population: Analysis population included all eligible participants whose data were observed in the study.

In this outcome measure, participants were categorized according to Fuhrman nuclear grade. The grades were classified as: grade 1, 2, 3, and 4. The four-tiered Fuhrman grading evaluates nuclear size, nuclear shape and presence of nucleolar prominence. Grade 1: small (=10 micrometer \[mcm\]) nuclear diameter, round/uniform nuclear shape and absent/inconspicuous nucleoli; Grade 2: large (=15 mcm) nuclear diameter, irregular outline nuclear shape and visible at \*400 magnification nucleoli; Grade 3: larger (=20 mcm) nuclear diameter, obvious irregular outline nuclear shape and visible and prominent at \*100 magnification nucleoli; Grade 4: grade 3 plus bizarre multilobed nuclei +/- spindle cells.

Time frame: Baseline (at Inclusion Visit)

Population: Analysis population included all eligible participants whose data were observed in the study. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure with non-missing values.

In this outcome measure, participants were categorized according to location of metastases at different body parts (lung, bones, liver, adrenal gland, pancreas, brain and lymph nodes). Participant can have more than 1 location of metastases.

Time frame: At initiation of sunitinib (at Inclusion Visit)

Population: Analysis population included all eligible participants whose data were observed in the study.

In this outcome measure, participants were categorized according to location of metastases at different body parts (lung, bones, liver, adrenal glands, pancreas, brain, lymph nodes, recurrence at nephrectomy site and other). Participant could have more than 1 location of metastases.

Time frame: Study visit at progression; post inclusion follow-up in the study was maximum of 39.8 months for Cases

Population: Analysis population included all eligible participants whose data were observed in the study. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.

In this outcome measure, participants were categorized according MSKCC prognostic classification. MSKCC criteria had 5 risk factors: Karnofsky performance status (KPS) \<80% (ability to perform ordinary tasks, 0 \[dead\] -100 \[normal\]); time from diagnosis to start of systemic therapy \<12 months; hemoglobin \<lower limit of normal (LLN); lactate dehydrogenase \>1.5\*upper limit of normal (ULN); corrected serum calcium \>10 milligram per deciliter (mg/dL). Present risk factors were added, and participants were stratified as: good prognosis (0 factor), intermediate prognosis (1-2 factors), poor prognosis (\>=2 factors).

Time frame: At initiation of sunitinib (at Inclusion Visit)

Population: Analysis population included all eligible participants whose data were observed in the study. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure with non-missing values.

In this outcome measure, participants were categorized according to the method of achieving the CR. Different methods included: treatment combined with local treatment and medical treatment alone. As per RECIST version 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 \<10 mm. Disappearance of all non-target lesions and normalization of tumour marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis).

Time frame: From initiation of sunitinib till CR (data collected at Inclusion Visit)

Population: Analysis population included all eligible participants whose data were observed in the study. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.

In this outcome measure, participants were categorized according to number of metastatic sites (1, 2 and 3).

Time frame: Study visit at progression; post inclusion follow-up in the study was maximum of 39.8 months for Cases

Population: Analysis population included all eligible participants whose data were observed in the study. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.

Time frame: At initiation of sunitinib (during follow up period maximum of 39.8 months for Cases)

Population: Data for this outcome measure was not collected, as there were less number of participants with an event.

In this outcome measure, participants were categorized according to number (1 and 2) of temporary discontinuations of sunitinib.

Time frame: Month 12 follow-up study visit

Population: Analysis population included all eligible participants whose data were observed in the study and who had attended at least Month 12 follow-up visit. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.

In this outcome measure, participants were categorized according to pathological classification. Pathological classification included: clear cell carcinoma (yes or no), multilocular cystic renal clear cell carcinoma (yes or no), papillary cell carcinoma (yes or no), chromophobe cell carcinoma(yes or no), Bellini's collecting duct carcinoma(yes or no), medullary cell carcinoma (yes or no), sarcomatoid contingent (yes or no), and other (yes or no).

Time frame: Baseline (at inclusion Visit)

Population: Analysis population included all eligible participants whose data were observed in the study.

In this outcome measure, participants were categorized according to presence of necrosis, pulmonary embolism and sarcomatoid component.

Time frame: Baseline (at Inclusion Visit)

Population: Analysis population included all eligible participants whose data were observed in the study. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure with non-missing values and number analyzed signifies participants evaluable at specific rows.

In this outcome measure, participants were categorized according to presence of nephrectomy as yes or no.

Time frame: Baseline (at inclusion Visit)

Population: Analysis population included all eligible participants whose data were observed in the study.

In this outcome measure, participants were categorized according to radiological assessment of the CR. It included: disappearance of all known target lesions, disappearance of all non-target lesions, no new lesions and all target and non-target lymph nodes. Only those categories with at least 1 participant as result are reported. As per RECIST version 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 \<10 mm. Disappearance of all non-target lesions and normalization of tumour marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis).

Time frame: From initiation of sunitinib till CR (data collected at Inclusion Visit)

Population: Analysis population included all eligible participants whose data were observed in the study. Here, number analyzed signifies participants evaluable with non-missing values for specified rows. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.

In this outcome measure, participants were categorized according to reasons for permanent discontinuation of sunitinib.

Time frame: Month 12 follow-up visit

Population: Analysis population included all eligible participants whose data were observed in the study and who had attended at least Month 12 follow-up visit. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.

Time frame: Month 24 follow-up study visit

Population: Analysis population included all eligible participants whose data were observed in the study and who had attended at least Month 24 follow-up visit. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.

In this outcome measure, participants were categorized according to recurrence at nephrectomy site were reported.

Time frame: At initiation of sunitinib (at Inclusion Visit)

Population: Analysis population included all eligible participants whose data were observed in the study.

In this outcome measure, participants were categorized according to recurrence at any other site than nephrectomy site were reported.

Time frame: At initiation of sunitinib (at Inclusion Visit)

Population: Analysis population included all eligible participants whose data were observed in the study.

As per RECIST version 1.1, PD was defined as at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.

Time frame: Study visit at progression; post inclusion follow-up in the study was maximum of 39.8 months for Cases

Population: Analysis population included all eligible participants whose data were observed in the study. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.

In this outcome measure, participants were categorized according to therapeutic strategy after CR. As per RECIST version 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 \<10 mm. Disappearance of all non-target lesions and normalization of tumour marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis). It included discontinuation and continuation of sunitinib treatment.

Time frame: After achieving CR with sunitinib treatment (data collected at Inclusion Visit)

Population: Analysis population included all eligible participants whose data were observed in the study. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.

In this outcome measure, participants were categorized according to the type of treatment Combined With local treatment alone as method of achieving the CR. Type of treatment combined with local treatment included: surgery, surgery + radiotherapy + radiofrequency + metastasectomy, metastasectomy, metastasectomy + other, radiofrequency + metastasectomy + other and radiotherapy. As per RECIST version 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 \<10 mm. Disappearance of all non-target lesions and normalization of tumour marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis).

Time frame: From initiation of sunitinib till CR (data collected at Inclusion Visit)

Population: Analysis population included all eligible participants whose data were observed in the study. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.

In this outcome measure, participants were categorized according to TNM classification. TNM classification included: T class (1, 2, 3, 4), N (0,1,2, x) and M class (0, 1). TNM system is based on size of primary tumor (T), amount of spread to lymph nodes (N) and presence of metastases (M). T1: tumor (less than or equal to) \<=20 millimeters (mm), T2: tumor \>20 mm to \<=50 mm, T3: \>50 mm, T4: tumor invading other structures. N0: no lymph node metastases, N1: metastases to ipsilateral level I, II axillary lymph nodes, NX: Regional lymph nodes cannot be assessed. M0: no clinical/radiographic evidence of distant metastases, M1: distant detectable metastases as determined by clinical and radiographic means and/or histologically proven \>0.2 mm.

Time frame: Baseline (at inclusion Visit)

Population: Analysis population included all eligible participants whose data were observed in the study. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants evaluable with non-missing value for specific rows.

In this outcome measure, participants were categorized according to type of lymph nodes as metastatic site.

Time frame: At initiation of sunitinib (at Initiation Visit)

Population: Analysis population included all eligible participants whose data were observed in the study. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants evaluable at specific rows.

In this outcome measure, participants were categorized according to type of lymph nodes as metastatic site were reported.

Time frame: Study visit at progression; post inclusion follow-up in the study was maximum of 39.8 months for Cases

Population: Analysis population included all eligible participants whose data were observed in the study. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.

In this outcome measure, participants were categorized according to the type of medical treatment alone as method of achieving the CR. Medical treatment alone included: surgery, radiotherapy, radiofrequency, cryoablation and metastasectomy. Only those categories in which at least 1 participant had data were reported. Participant could have received more than 1 type of medical treatment. As per RECIST version 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 \<10 mm. Disappearance of all non-target lesions and normalization of tumour marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis).

Time frame: From initiation of sunitinib till CR (data collected at Inclusion Visit)

Population: Analysis population included all eligible participants whose data were observed in the study. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.

In this outcome measure, participants were categorized according to type of nephrectomy. Various types of nephrectomies included: extended or partial, nephrectomy with or without adrenalectomy, nephrectomy with or without curettage and open or laparoscopic nephrectomy.

Time frame: Baseline (at inclusion Visit)

Population: Analysis population included all eligible participants whose data were observed in the study. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants evaluable with non-missing values for specific rows.

In this outcome measure, participants who received systemic treatment after progression were categorized according to type of treatment. Different types of treatment were tyrosine kinase inhibitor- sunitinib restart, radiotherapy and other systemic treatment. Participant could have more than 1 type of treatment.

Time frame: After progression, during follow up period maximum of 39.8 months for Cases

Population: Analysis population included all eligible participants whose data were observed in the study. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.

As per RECIST version 1.1, PD was defined as at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.

Time frame: Study visit at progression; post inclusion follow-up in the study was maximum of 39.8 months for Cases

Population: Analysis population included all eligible participants whose data were observed in the study. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.

Time frame: At initiation of sunitinib (during follow up period maximum of 39.8 months for Cases)

Population: Data for this outcome measure was not collected, as there were less number of participants who had response.

In this outcome measure, participants who died during the study were reported.

Time frame: At initiation of sunitinib (during follow up period maximum of 39.8 months for Cases)

Population: Analysis population included all eligible participants whose data were observed in the study. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.

In this outcome measure, number of participants who permanently discontinued sunitinib were reported.

Time frame: Month 12 follow-up study visit

Population: Analysis population included all eligible participants whose data were observed in the study and who had attended at least Month 12 follow-up visit. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure with non-missing values. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.

Time frame: Month 24 follow-up study visit

Population: Analysis population included all eligible participants whose data were observed in the study and who had attended at least Month 24 follow-up visit. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.

In this outcome measure, participants who temporarily discontinued sunitinib were reported.

Time frame: Month 12 follow-up study visit

Population: Analysis population included all eligible participants whose data were observed in the study and who had attended at least Month 12 follow-up visit. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.

In this outcome measure, number of participants who temporarily discontinued sunitinib were reported.

Time frame: Month 24 follow-up study visit

Population: Analysis population included all eligible participants whose data were observed in the study and who had attended at least Month 24 follow-up visit. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.

In this outcome measure, participants who received systemic treatment after progression were reported.

Time frame: After progression, during follow up period maximum of 39.8 months for Cases

Population: Analysis population included all eligible participants whose data were observed in the study. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.

In this outcome measure, participants who resumed sunitinib were reported.

Time frame: Month 24 follow-up study visit

Population: Analysis population included all eligible participants whose data were observed in the study and who had attended at least Month 24 follow-up visit. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.

Participants who terminated study early were reported in this outcome measure.

Time frame: From inclusion in the study till termination (during follow up period maximum of 39.8 months for Cases)

Population: Analysis population included all eligible participants whose data were observed in the study. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.

An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. A serious AE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; congenital anomaly/birth defect and other important medical events.

Time frame: During follow up period maximum of 39.8 months for Cases and 37 months for Controls

Population: Analysis population included all eligible participants whose data were observed in the study and who had attended at least one follow-up visit. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure.

An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, possibly considered related to the study treatment. A serious AE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; congenital anomaly/birth defect and other important medical events.

Time frame: During follow up period maximum of 39.8 months for Cases and 37 months for Controls

Population: Analysis population included all eligible participants whose data were observed in the study. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure.

Participants with best objective response after progression were evaluated here. It included complete, partial, stabilized and not applicable. PD per RECIST v1.1: at least a 20% increase in sum of diameters of target lesions,taking as reference smallest sum on study. In addition to relative increase of 20%, sum must also demonstrate an absolute increase of at least 5mm. Appearance of one or more new lesions was also considered progression. CR:disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<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) & SD: absence of sufficient reduction for a PR: at least 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters or absence of a sufficient increase for PD, taking as reference the sum of lowest diameters during study.

Time frame: At the end of study visit follow-up (during follow up period maximum of 39.8 months for Cases)

Population: Analysis population included all eligible participants whose data were observed in the study and who had attended at least end of study visit follow up. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure with non-missing values. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.

DE included: CR, PD, SD and not assessed. PD: per RECIST v1.1: at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study. In addition to relative increase of 20%, sum must also demonstrate an absolute increase of at least 5mm. Appearance of one or more new lesions was also considered progression. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<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).SD: absence of sufficient reduction for PR: at least 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters or absence of a sufficient increase for PD, taking as reference the sum of lowest diameters during study.

Time frame: Month 24 follow-up study visit

Population: Analysis population included all eligible participants whose data were observed in the study and who had attended at least Month 24 follow-up visit. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure with non-missing values. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.

DE included:complete response, progression, stabilization and not assessed. Disease progression (PD):per RECIST v1.1: at least 20% increase in sum of diameters of target lesions,taking as reference smallest sum on study.In addition to relative increase of 20%, sum must also demonstrate an absolute increase of at least 5mm.Appearance of 1 or more new lesions was also considered progression. CR:disappearance of all target lesions.Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<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) and stable disease (SD): absence of sufficient reduction for a partial response (PR): at least 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters or absence of a sufficient increase for PD, taking as reference the sum of lowest diameters during study.

Time frame: Month 12 follow-up visit

Population: Analysis population included all eligible participants whose data were observed in the study and who had attended at least Month 12 follow-up visit. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure with non-missing values. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.

In this outcome measure, participants with ongoing sunitinib treatment according to dose (25, 37.5 and 50 mg) and regimen (4/2 \[4 weeks dosing then 2 weeks off\] and 2/1 \[4 weeks dosing then 2 weeks off\]) were reported.

Time frame: Month 12 follow-up study visit

Population: Analysis population included all eligible participants whose data were observed in the study and who had attended at least Month 12 follow-up visit. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.

In this outcome measure, participants with ongoing sunitinib treatment were reported.

Time frame: Month 12 follow-up study visit

Population: Analysis population included all eligible participants whose data were observed in the study and who had attended at least Month 12 follow-up visit. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure with non-missing values. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.

In this outcome measure, participants with ongoing sunitinib treatment were reported.

Time frame: Month 24 follow-up study visit

Population: Analysis population included all eligible participants whose data were observed in the study and who had attended at least Month 24 follow-up visit. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.

PFS was based on Kaplan-Meier estimates. PFS was defined as time in months from start of treatment-to-treatment discontinuation due to disease progression as assessed by the investigator. PD: =\>20% increase in sum of longest dimensions of lesions taking as a reference smallest sum of longest dimensions since treatment start or appearance of =\>1 new lesions. Disease progression was determined from oncologic assessment data (where data meet the criteria for PD), or from death case report forms (CRFs). This outcome measure was analyzed by using Kaplan-Meier method.

Time frame: At the end of the study (inclusion period was of 3 years and follow up period maximum of 39.8 months for Cases)

Population: Analysis population included all eligible participants whose data were observed in the study. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.

In this outcome measure, time taken by participants to achieve the complete remission after sunitinib initiation were reported. As per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 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 size of \<10 millimeter (mm).

Time frame: From initiation of sunitinib till CR (data collected at Inclusion Visit)

Population: Analysis population included all eligible participants whose data were observed in the study. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.

Time to diagnose metastatic renal cell carcinoma was defined as the duration between date of diagnosis of mRCC to date of inclusion visit.

Time frame: Baseline (at inclusion Visit)

Population: Analysis population included all eligible participants whose data were observed in the study.

Time frame: Diagnosis of mRCC to Sunitinib Initiation (at Inclusion Visit)

Population: Analysis population included all eligible participants whose data were observed in the study. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure with non-missing values.

In this outcome measure, time from diagnosis of mRCC to nephrectomy was reported.

Time frame: Baseline (at inclusion Visit)

Population: Analysis population included all eligible participants whose data were observed in the study. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure.

CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<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). PD: =\>20% increase in sum of longest dimensions of lesions taking as a reference smallest sum of longest dimensions since treatment start or appearance of =\>1 new lesions.

Time frame: From achieving CR with Sunitinib treatment (before inclusion in the study, participants recruited for 3 years) to Visit at progression (during study); [post inclusion follow-up in the study was maximum of 39.8 months for Cases]

Population: Analysis population included all eligible participants whose data were observed in the study and who had attended at least Month 24 follow-up visit. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.

Tumour size of participants was reported in this outcome measure.

Time frame: Baseline (at Inclusion Visit)

Population: Analysis population included all eligible participants whose data were observed in the study. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure.

Time frame: During follow up period maximum of 39.8 months for Cases and 37 months for Controls

Population: Data was not available as the participating centers did not return the biological samples accordingly, to realize the analysis.