Trial Outcomes & Findings for Study On Fatigue- And Hand-Foot Syndrome-Related Quality Of Life In Patients With Metastatic Renal Cell Carcinoma Receiving A Tyrosine Kinase Inhibitor as First-Line Treatment (NCT NCT02789137)

Results Overview

In this outcome measure, number of participants were classified according to their habit of taking daytime rest (naps) as never, always and sometimes. Never is defined as someone who does not take any daytime nap, always is defined as someone who takes daytime naps daily and sometimes is defined as someone who takes daytime naps on weekends or on holidays.

Recruitment status

COMPLETED

Target enrollment

111 participants

Primary outcome timeframe

Baseline

Results posted on

2021-11-05

Participant Flow

Participants aged above or equal to 18 years, who were diagnosed with metastatic renal cell carcinoma (mRCC), and were to initiate tyrosine kinase inhibitor (TKI) as first-line treatment as per normal routine healthcare practice in real world were included in this prospective, observational study. Participants were to be followed up for at least 9 months after treatment initiation and till they switched to second line treatment before end of the study (maximum duration of 3.8 years).

Participant milestones

Participant milestones
Measure	Tyrosine Kinase Inhibitor Participants diagnosed with mRCC who received TKI as first line treatment, prescribed by physician, in real world practice were observed in this study.
Overall Study STARTED	111
Overall Study COMPLETED	53
Overall Study NOT COMPLETED	58

Reasons for withdrawal

Reasons for withdrawal
Measure	Tyrosine Kinase Inhibitor Participants diagnosed with mRCC who received TKI as first line treatment, prescribed by physician, in real world practice were observed in this study.
Overall Study Dropped out/Died	58

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tyrosine Kinase Inhibitor n=111 Participants Participants diagnosed with mRCC who received TKI as first line treatment, prescribed by physician, in real world practice were observed in this study.
Age, Continuous	62.9 Years STANDARD_DEVIATION 10.7 • n=111 Participants
Sex: Female, Male Female	31 Participants n=111 Participants
Sex: Female, Male Male	80 Participants n=111 Participants
Eastern Cooperative Oncology Group Performance Status (ECOG PS) Less Than or Equal to (<=) 2 0	55 Participants n=111 Participants
Eastern Cooperative Oncology Group Performance Status (ECOG PS) Less Than or Equal to (<=) 2 1	45 Participants n=111 Participants
Eastern Cooperative Oncology Group Performance Status (ECOG PS) Less Than or Equal to (<=) 2 2	11 Participants n=111 Participants
Heng Prognostic Criteria Favourable	28 Participants n=111 Participants
Heng Prognostic Criteria Intermediate	57 Participants n=111 Participants
Heng Prognostic Criteria Poor prognosis	26 Participants n=111 Participants
Site of Metastasis Lung	73 Participants n=111 Participants
Site of Metastasis Brain	3 Participants n=111 Participants
Site of Metastasis Nodes	38 Participants n=111 Participants
Site of Metastasis Bone	29 Participants n=111 Participants
Site of Metastasis Liver	26 Participants n=111 Participants
Site of Metastasis Kidney	9 Participants n=111 Participants
Site of Metastasis Other	32 Participants n=111 Participants
Number of Metastatic Sites 1	47 Participants n=111 Participants
Number of Metastatic Sites 2	36 Participants n=111 Participants
Number of Metastatic Sites 3	19 Participants n=111 Participants
Number of Metastatic Sites 4	6 Participants n=111 Participants
Number of Metastatic Sites 5	3 Participants n=111 Participants
Histological Type Clear cell	86 Participants n=111 Participants
Histological Type Chromophobe	3 Participants n=111 Participants
Histological Type Papillary type 1	4 Participants n=111 Participants
Histological Type Papillary type 2	5 Participants n=111 Participants
Histological Type Mixed	3 Participants n=111 Participants
Histological Type Sarcomatoid	2 Participants n=111 Participants
Histological Type Not performed	8 Participants n=111 Participants
Smoking Status No	79 Participants n=111 Participants
Smoking Status Yes	20 Participants n=111 Participants
Smoking Status Occasional	1 Participants n=111 Participants
Smoking Status Former Smoker	11 Participants n=111 Participants
Time Elapsed From the Time of Diagnosis of the Disease	31.5 Months STANDARD_DEVIATION 56.9 • n=111 Participants
Time Elapsed From the Time of Advanced Diagnosis of the Disease	2.6 Months STANDARD_DEVIATION 4.8 • n=111 Participants
Number of Participants Categorized According to Tyrosine Kinase Inhibitor Dose and Treatment Regimen Pazopanib 800 mg daily without rest days	11 Participants n=111 Participants
Number of Participants Categorized According to Tyrosine Kinase Inhibitor Dose and Treatment Regimen Sunitinib 50 mg, Regimen 4/2	83 Participants n=111 Participants
Number of Participants Categorized According to Tyrosine Kinase Inhibitor Dose and Treatment Regimen Sunitinib 50 mg, Regimen 2/1	10 Participants n=111 Participants
Number of Participants Categorized According to Tyrosine Kinase Inhibitor Dose and Treatment Regimen Sunitinib 37.5 mg, Regimen 4/2	2 Participants n=111 Participants
Number of Participants Categorized According to Tyrosine Kinase Inhibitor Dose and Treatment Regimen Sunitinib 37.5 mg, Regimen 2/1	3 Participants n=111 Participants
Number of Participants Categorized According to Tyrosine Kinase Inhibitor Dose and Treatment Regimen Sunitinib 25 mg, Regimen 2/1	2 Participants n=111 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Analysis population included all eligible participants who were included in this study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

In this outcome measure, number of participants were classified according to their habit of taking daytime rest (naps) as never, always and sometimes. Never is defined as someone who does not take any daytime nap, always is defined as someone who takes daytime naps daily and sometimes is defined as someone who takes daytime naps on weekends or on holidays.

Outcome measures

Outcome measures
Measure	Tyrosine Kinase Inhibitor n=86 Participants Participants diagnosed with mRCC who received TKI as first line treatment, prescribed by physician, in real world practice were observed in this study.
Number of Participants Categorized According to the Napping Habits for All Participants at Baseline Never	22 Participants
Number of Participants Categorized According to the Napping Habits for All Participants at Baseline Always	33 Participants
Number of Participants Categorized According to the Napping Habits for All Participants at Baseline Sometimes	31 Participants

PRIMARY outcome

Timeframe: Week 12

Population: Analysis population included all eligible participants who were included in this study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

In this outcome measure, number of participants were classified according to their habit of taking daytime rest (naps) as never, always and sometimes. Never is defined as someone who does not take any daytime nap, always is defined as someone who takes daytime naps daily and sometimes is defined as someone who takes daytime naps on weekends or on holidays.

Outcome measures

Outcome measures
Measure	Tyrosine Kinase Inhibitor n=63 Participants Participants diagnosed with mRCC who received TKI as first line treatment, prescribed by physician, in real world practice were observed in this study.
Number of Participants Categorized According to the Napping Habits for All Participants at Week 12 Never	18 Participants
Number of Participants Categorized According to the Napping Habits for All Participants at Week 12 Always	24 Participants
Number of Participants Categorized According to the Napping Habits for All Participants at Week 12 Sometimes	21 Participants

PRIMARY outcome

Timeframe: Week 24

Population: Analysis population included all eligible participants who were included in this study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

In this outcome measure, number of participants were classified according to their habit of taking daytime rest (naps) as never, always and sometimes. Never is defined as someone who does not take any daytime nap, always is defined as someone who takes daytime naps daily and sometimes is defined as someone who takes daytime naps on weekends or on holidays.

Outcome measures

Outcome measures
Measure	Tyrosine Kinase Inhibitor n=45 Participants Participants diagnosed with mRCC who received TKI as first line treatment, prescribed by physician, in real world practice were observed in this study.
Number of Participants Categorized According to the Napping Habits for All Participants at Week 24 Never	18 Participants
Number of Participants Categorized According to the Napping Habits for All Participants at Week 24 Always	15 Participants
Number of Participants Categorized According to the Napping Habits for All Participants at Week 24 Sometimes	12 Participants

PRIMARY outcome

Timeframe: Week 36

Population: Analysis population included all eligible participants who were included in this study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

In this outcome measure, number of participants were classified according to their habit of taking daytime rest (naps) as never, always and sometimes. Never is defined as someone who does not take any daytime nap, always is defined as someone who takes daytime naps daily and sometimes is defined as someone who takes daytime naps on weekends or on holidays.

Outcome measures

Outcome measures
Measure	Tyrosine Kinase Inhibitor n=41 Participants Participants diagnosed with mRCC who received TKI as first line treatment, prescribed by physician, in real world practice were observed in this study.
Number of Participants Categorized According to the Napping Habits for All Participants at Week 36 Never	16 Participants
Number of Participants Categorized According to the Napping Habits for All Participants at Week 36 Always	16 Participants
Number of Participants Categorized According to the Napping Habits for All Participants at Week 36 Sometimes	9 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Analysis population included all eligible participants who were included in this study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.

In this outcome measure, number of participants were classified according to the presence or absence of fatigue based on their habit of performing aerobic physical exercise as never, always and sometimes.

Outcome measures

Outcome measures
Measure	Tyrosine Kinase Inhibitor n=87 Participants Participants diagnosed with mRCC who received TKI as first line treatment, prescribed by physician, in real world practice were observed in this study.
Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Baseline Fatigue: Yes · Never Exercise	10 Participants
Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Baseline Fatigue: Yes · Always Exercise	0 Participants
Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Baseline Fatigue: Yes · Sometimes Exercise	7 Participants
Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Baseline Fatigue: No · Never Exercise	34 Participants
Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Baseline Fatigue: No · Always Exercise	14 Participants
Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Baseline Fatigue: No · Sometimes Exercise	22 Participants

PRIMARY outcome

Timeframe: Week 12

Population: Analysis population included all eligible participants who were included in this study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.

In this outcome measure, number of participants were classified according to the presence or absence of fatigue based on their habit of performing aerobic physical exercise as never, always and sometimes.

Outcome measures

Outcome measures
Measure	Tyrosine Kinase Inhibitor n=62 Participants Participants diagnosed with mRCC who received TKI as first line treatment, prescribed by physician, in real world practice were observed in this study.
Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Week 12 Fatigue: Yes · Never Exercise	14 Participants
Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Week 12 Fatigue: Yes · Always Exercise	6 Participants
Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Week 12 Fatigue: Yes · Sometimes Exercise	10 Participants
Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Week 12 Fatigue: No · Never Exercise	9 Participants
Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Week 12 Fatigue: No · Always Exercise	12 Participants
Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Week 12 Fatigue: No · Sometimes Exercise	11 Participants

PRIMARY outcome

Timeframe: Week 24

Population: Analysis population included all eligible participants who were included in this study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.

In this outcome measure, number of participants were classified according to the presence or absence of fatigue based on their habit of performing aerobic physical exercise as never, always and sometimes.

Outcome measures

Outcome measures
Measure	Tyrosine Kinase Inhibitor n=47 Participants Participants diagnosed with mRCC who received TKI as first line treatment, prescribed by physician, in real world practice were observed in this study.
Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Week 24 Fatigue: Yes · Never Exercise	13 Participants
Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Week 24 Fatigue: Yes · Always Exercise	5 Participants
Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Week 24 Fatigue: Yes · Sometimes Exercise	7 Participants
Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Week 24 Fatigue: No · Never Exercise	10 Participants
Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Week 24 Fatigue: No · Always Exercise	5 Participants
Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Week 24 Fatigue: No · Sometimes Exercise	7 Participants

PRIMARY outcome

Timeframe: Week 36

Population: Analysis population included all eligible participants who were included in this study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.

In this outcome measure, number of participants were classified according to the presence or absence of fatigue based on their habit of performing aerobic physical exercise as never, always and sometimes.

Outcome measures

Outcome measures
Measure	Tyrosine Kinase Inhibitor n=41 Participants Participants diagnosed with mRCC who received TKI as first line treatment, prescribed by physician, in real world practice were observed in this study.
Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Week 36 Fatigue: Yes · Never Exercise	4 Participants
Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Week 36 Fatigue: Yes · Always Exercise	1 Participants
Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Week 36 Fatigue: Yes · Sometimes Exercise	3 Participants
Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Week 36 Fatigue: No · Never Exercise	19 Participants
Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Week 36 Fatigue: No · Always Exercise	5 Participants
Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Week 36 Fatigue: No · Sometimes Exercise	9 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Analysis population included all eligible participants who were included in this study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

FACIT-F was a 13-item questionnaire which assessed self-reported fatigue and its impact upon daily activities and function. Participants responded to each item on a 5-point scale based on their experience of fatigue during the past 7 days (0= not at all; 1= a little bit; 2= somewhat; 3= quite a bit; 4= very much). FACIT-F score was calculated by summing the 13 items (range 0 \[not at all\] to 52 \[very much\]); higher scores represented less fatigue and better status of participants.

Outcome measures

Outcome measures
Measure	Tyrosine Kinase Inhibitor n=86 Participants Participants diagnosed with mRCC who received TKI as first line treatment, prescribed by physician, in real world practice were observed in this study.
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Baseline	40.0 Units on a scale Standard Deviation 9.6

PRIMARY outcome

Timeframe: Week 6

Population: Analysis population included all eligible participants who were included in this study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

FACIT-F was a 13-item questionnaire which assessed self-reported fatigue and its impact upon daily activities and function. Participants responded to each item on a 5-point scale based on their experience of fatigue during the past 7 days (0= not at all; 1= a little bit; 2= somewhat; 3= quite a bit; 4= very much). FACIT-F score was calculated by summing the 13 items (range 0 \[not at all\] to 52 \[very much\]); higher scores represented less fatigue and better status of participants.

Outcome measures

Outcome measures
Measure	Tyrosine Kinase Inhibitor n=83 Participants Participants diagnosed with mRCC who received TKI as first line treatment, prescribed by physician, in real world practice were observed in this study.
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 6	34.7 Units on a scale Standard Deviation 11.4

PRIMARY outcome

Timeframe: Week 12

Population: Analysis population included all eligible participants who were included in this study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

FACIT-F was a 13-item questionnaire which assessed self-reported fatigue and its impact upon daily activities and function. Participants responded to each item on a 5-point scale based on their experience of fatigue during the past 7 days (0= not at all; 1= a little bit; 2= somewhat; 3= quite a bit; 4= very much). FACIT-F score was calculated by summing the 13 items (range 0 \[not at all\] to 52 \[very much\]); higher scores represented less fatigue and better status of participants.

Outcome measures

Outcome measures
Measure	Tyrosine Kinase Inhibitor n=61 Participants Participants diagnosed with mRCC who received TKI as first line treatment, prescribed by physician, in real world practice were observed in this study.
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 12	36.4 Units on a scale Standard Deviation 10.6

PRIMARY outcome

Timeframe: Week 18

Population: Analysis population included all eligible participants who were included in this study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

FACIT-F was a 13-item questionnaire which assessed self-reported fatigue and its impact upon daily activities and function. Participants responded to each item on a 5-point scale based on their experience of fatigue during the past 7 days (0= not at all; 1= a little bit; 2= somewhat; 3= quite a bit; 4= very much). FACIT-F score was calculated by summing the 13 items (range 0 \[not at all\] to 52 \[very much\]); higher scores represented less fatigue and better status of participants.

Outcome measures

Outcome measures
Measure	Tyrosine Kinase Inhibitor n=57 Participants Participants diagnosed with mRCC who received TKI as first line treatment, prescribed by physician, in real world practice were observed in this study.
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 18	35.3 Units on a scale Standard Deviation 11.5

PRIMARY outcome

Timeframe: Week 24

Population: Analysis population included all eligible participants who were included in this study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

FACIT-F was a 13-item questionnaire which assessed self-reported fatigue and its impact upon daily activities and function. Participants responded to each item on a 5-point scale based on their experience of fatigue during the past 7 days (0= not at all; 1= a little bit; 2= somewhat; 3= quite a bit; 4= very much). FACIT-F score was calculated by summing the 13 items (range 0 \[not at all\] to 52 \[very much\]); higher scores represented less fatigue and better status of participants.

Outcome measures

Outcome measures
Measure	Tyrosine Kinase Inhibitor n=43 Participants Participants diagnosed with mRCC who received TKI as first line treatment, prescribed by physician, in real world practice were observed in this study.
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 24	36.3 Units on a scale Standard Deviation 11.1

PRIMARY outcome

Timeframe: Week 30

Population: Analysis population included all eligible participants who were included in this study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

FACIT-F was a 13-item questionnaire which assessed self-reported fatigue and its impact upon daily activities and function. Participants responded to each item on a 5-point scale based on their experience of fatigue during the past 7 days (0= not at all; 1= a little bit; 2= somewhat; 3= quite a bit; 4= very much). FACIT-F score was calculated by summing the 13 items (range 0 \[not at all\] to 52 \[very much\]); higher scores represented less fatigue and better status of participants.

Outcome measures

Outcome measures
Measure	Tyrosine Kinase Inhibitor n=43 Participants Participants diagnosed with mRCC who received TKI as first line treatment, prescribed by physician, in real world practice were observed in this study.
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 30	34.9 Units on a scale Standard Deviation 11.3

PRIMARY outcome

Timeframe: Week 36

Population: Analysis population included all eligible participants who were included in this study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

FACIT-F was a 13-item questionnaire which assessed self-reported fatigue and its impact upon daily activities and function. Participants responded to each item on a 5-point scale based on their experience of fatigue during the past 7 days (0= not at all; 1= a little bit; 2= somewhat; 3= quite a bit; 4= very much). FACIT-F score was calculated by summing the 13 items (range 0 \[not at all\] to 52 \[very much\]); higher scores represented less fatigue and better status of participants.

Outcome measures

Outcome measures
Measure	Tyrosine Kinase Inhibitor n=43 Participants Participants diagnosed with mRCC who received TKI as first line treatment, prescribed by physician, in real world practice were observed in this study.
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 36	35.5 Units on a scale Standard Deviation 10.2

PRIMARY outcome

Timeframe: Week 1

Population: Analysis population included all eligible participants who were included in this study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

In this outcome measure, the number of participants were classified on the basis of the time of taking the oral medication - "morning, afternoon or night". Morning was anytime between 7 am to 12 pm. Afternoon was anytime between 1 pm and 7 pm. Night was anytime between 8 pm to 6 am. Participants who did not take medication were also classified.

Outcome measures

Outcome measures
Measure	Tyrosine Kinase Inhibitor n=86 Participants Participants diagnosed with mRCC who received TKI as first line treatment, prescribed by physician, in real world practice were observed in this study.
Number of Participants Classified According to Time of Taking Treatment at Week 1 Morning	39 Participants
Number of Participants Classified According to Time of Taking Treatment at Week 1 Afternoon	31 Participants
Number of Participants Classified According to Time of Taking Treatment at Week 1 Night	15 Participants
Number of Participants Classified According to Time of Taking Treatment at Week 1 Participant did not take medication in this week	1 Participants

PRIMARY outcome

Timeframe: Week 6

Population: Analysis population included all eligible participants who were included in this study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

In this outcome measure, the number of participants were classified on the basis of the time of taking the oral medication - "morning, afternoon or night". Morning was anytime between 7 am to 12 pm. Afternoon was anytime between 1 pm and 7 pm. Night was anytime between 8 pm to 6 am. Participants who did not take medication were also classified.

Outcome measures

Outcome measures
Measure	Tyrosine Kinase Inhibitor n=82 Participants Participants diagnosed with mRCC who received TKI as first line treatment, prescribed by physician, in real world practice were observed in this study.
Number of Participants Classified According to Time of Taking Treatment at Week 6 Morning	19 Participants
Number of Participants Classified According to Time of Taking Treatment at Week 6 Afternoon	13 Participants
Number of Participants Classified According to Time of Taking Treatment at Week 6 Night	7 Participants
Number of Participants Classified According to Time of Taking Treatment at Week 6 Participant did not take medication in this week	43 Participants

PRIMARY outcome

Timeframe: Week 12

Population: Analysis population included all eligible participants who were included in this study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

In this outcome measure, the number of participants were classified on the basis of the time of taking the oral medication - "morning, afternoon or night". Morning was anytime between 7 am to 12 pm. Afternoon was anytime between 1 pm and 7 pm. Night was anytime between 8 pm to 6 am. Participants who did not take medication were also classified.

Outcome measures

Outcome measures
Measure	Tyrosine Kinase Inhibitor n=63 Participants Participants diagnosed with mRCC who received TKI as first line treatment, prescribed by physician, in real world practice were observed in this study.
Number of Participants Classified According to Time of Taking Treatment at Week 12 Morning	21 Participants
Number of Participants Classified According to Time of Taking Treatment at Week 12 Afternoon	10 Participants
Number of Participants Classified According to Time of Taking Treatment at Week 12 Night	10 Participants
Number of Participants Classified According to Time of Taking Treatment at Week 12 Participant did not take medication in this week	22 Participants

PRIMARY outcome

Timeframe: Week 18

Population: Analysis population included all eligible participants who were included in this study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

In this outcome measure, the number of participants were classified on the basis of the time of taking the oral medication - "morning, afternoon or night". Morning was anytime between 7 am to 12 pm. Afternoon was anytime between 1 pm and 7 pm. Night was anytime between 8 pm to 6 am. Participants who did not take medication were also classified.

Outcome measures

Outcome measures
Measure	Tyrosine Kinase Inhibitor n=58 Participants Participants diagnosed with mRCC who received TKI as first line treatment, prescribed by physician, in real world practice were observed in this study.
Number of Participants Classified According to Time of Taking Treatment at Week 18 Morning	19 Participants
Number of Participants Classified According to Time of Taking Treatment at Week 18 Afternoon	9 Participants
Number of Participants Classified According to Time of Taking Treatment at Week 18 Night	6 Participants
Number of Participants Classified According to Time of Taking Treatment at Week 18 Participant did not take medication in this week	24 Participants

PRIMARY outcome

Timeframe: Week 24

Population: Analysis population included all eligible participants who were included in this study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

In this outcome measure, the number of participants were classified on the basis of the time of taking the oral medication - "morning, afternoon or night". Morning was anytime between 7 am to 12 pm. Afternoon was anytime between 1 pm and 7 pm. Night was anytime between 8 pm to 6 am. Participants who did not take medication were also classified.

Outcome measures

Outcome measures
Measure	Tyrosine Kinase Inhibitor n=45 Participants Participants diagnosed with mRCC who received TKI as first line treatment, prescribed by physician, in real world practice were observed in this study.
Number of Participants Classified According to Time of Taking Treatment at Week 24 Morning	12 Participants
Number of Participants Classified According to Time of Taking Treatment at Week 24 Afternoon	8 Participants
Number of Participants Classified According to Time of Taking Treatment at Week 24 Night	12 Participants
Number of Participants Classified According to Time of Taking Treatment at Week 24 Participant did not take medication in this week	13 Participants

PRIMARY outcome

Timeframe: Week 30

Population: Analysis population included all eligible participants who were included in this study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

In this outcome measure, the number of participants were classified on the basis of the time of taking the oral medication - "morning, afternoon or night". Morning was anytime between 7 am to 12 pm. Afternoon was anytime between 1 pm and 7 pm. Night was anytime between 8 pm to 6 am. Participants who did not take medication were also classified.

Outcome measures

Outcome measures
Measure	Tyrosine Kinase Inhibitor n=45 Participants Participants diagnosed with mRCC who received TKI as first line treatment, prescribed by physician, in real world practice were observed in this study.
Number of Participants Classified According to Time of Taking Treatment at Week 30 Morning	12 Participants
Number of Participants Classified According to Time of Taking Treatment at Week 30 Afternoon	9 Participants
Number of Participants Classified According to Time of Taking Treatment at Week 30 Night	10 Participants
Number of Participants Classified According to Time of Taking Treatment at Week 30 Participant did not take medication in this week	14 Participants

PRIMARY outcome

Timeframe: Week 36

Population: Analysis population included all eligible participants who were included in this study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

In this outcome measure, the number of participants were classified on the basis of the time of taking the oral medication - "morning, afternoon or night". Morning was anytime between 7 am to 12 pm. Afternoon was anytime between 1 pm and 7 pm. Night was anytime between 8 pm to 6 am. Participants who did not take medication were also classified.

Outcome measures

Outcome measures
Measure	Tyrosine Kinase Inhibitor n=41 Participants Participants diagnosed with mRCC who received TKI as first line treatment, prescribed by physician, in real world practice were observed in this study.
Number of Participants Classified According to Time of Taking Treatment at Week 36 Morning	10 Participants
Number of Participants Classified According to Time of Taking Treatment at Week 36 Afternoon	8 Participants
Number of Participants Classified According to Time of Taking Treatment at Week 36 Night	7 Participants
Number of Participants Classified According to Time of Taking Treatment at Week 36 Participant did not take medication in this week	16 Participants

PRIMARY outcome

Timeframe: During 9 months

Population: Analysis population included all eligible participants who were included in this study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.

In this outcome measure, number of participants were classified according to the number of changes to dose that is (i.e). 0, 1 or 2 occurred per treatment cycle during 9 months of follow-up.

Outcome measures

Outcome measures
Measure	Tyrosine Kinase Inhibitor n=101 Participants Participants diagnosed with mRCC who received TKI as first line treatment, prescribed by physician, in real world practice were observed in this study.
Number of Participants Categorized According to Number of Changes to Dose Per Treatment Cycle During 9 Months of Follow-up Changes to Dose Occurred in Cycle 1 · 0	82 Participants
Number of Participants Categorized According to Number of Changes to Dose Per Treatment Cycle During 9 Months of Follow-up Changes to Dose Occurred in Cycle 1 · 1	19 Participants
Number of Participants Categorized According to Number of Changes to Dose Per Treatment Cycle During 9 Months of Follow-up Changes to Dose Occurred in Cycle 1 · 2	0 Participants
Number of Participants Categorized According to Number of Changes to Dose Per Treatment Cycle During 9 Months of Follow-up Changes to Dose Occurred in Cycle 2 · 0	69 Participants
Number of Participants Categorized According to Number of Changes to Dose Per Treatment Cycle During 9 Months of Follow-up Changes to Dose Occurred in Cycle 2 · 1	25 Participants
Number of Participants Categorized According to Number of Changes to Dose Per Treatment Cycle During 9 Months of Follow-up Changes to Dose Occurred in Cycle 2 · 2	0 Participants
Number of Participants Categorized According to Number of Changes to Dose Per Treatment Cycle During 9 Months of Follow-up Changes to Dose Occurred in Cycle 3 · 0	55 Participants
Number of Participants Categorized According to Number of Changes to Dose Per Treatment Cycle During 9 Months of Follow-up Changes to Dose Occurred in Cycle 3 · 1	17 Participants
Number of Participants Categorized According to Number of Changes to Dose Per Treatment Cycle During 9 Months of Follow-up Changes to Dose Occurred in Cycle 3 · 2	0 Participants
Number of Participants Categorized According to Number of Changes to Dose Per Treatment Cycle During 9 Months of Follow-up Changes to Dose Occurred in Cycle 4 · 0	60 Participants
Number of Participants Categorized According to Number of Changes to Dose Per Treatment Cycle During 9 Months of Follow-up Changes to Dose Occurred in Cycle 4 · 1	7 Participants
Number of Participants Categorized According to Number of Changes to Dose Per Treatment Cycle During 9 Months of Follow-up Changes to Dose Occurred in Cycle 4 · 2	1 Participants
Number of Participants Categorized According to Number of Changes to Dose Per Treatment Cycle During 9 Months of Follow-up Changes to Dose Occurred in Cycle 5 · 0	46 Participants
Number of Participants Categorized According to Number of Changes to Dose Per Treatment Cycle During 9 Months of Follow-up Changes to Dose Occurred in Cycle 5 · 1	9 Participants
Number of Participants Categorized According to Number of Changes to Dose Per Treatment Cycle During 9 Months of Follow-up Changes to Dose Occurred in Cycle 5 · 2	0 Participants
Number of Participants Categorized According to Number of Changes to Dose Per Treatment Cycle During 9 Months of Follow-up Changes to Dose Occurred in Cycle 6 · 0	49 Participants
Number of Participants Categorized According to Number of Changes to Dose Per Treatment Cycle During 9 Months of Follow-up Changes to Dose Occurred in Cycle 6 · 1	4 Participants
Number of Participants Categorized According to Number of Changes to Dose Per Treatment Cycle During 9 Months of Follow-up Changes to Dose Occurred in Cycle 6 · 2	0 Participants

PRIMARY outcome

Timeframe: During 9 months

Population: Analysis population included all eligible participants who were included in this study. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.

In this outcome measure, number of participants were classified according to the number of interruptions to dose i.e. 0, 1, 2, 3 or 4 occurred in each treatment cycle during 9 months follow-up.

Outcome measures

Outcome measures
Measure	Tyrosine Kinase Inhibitor n=111 Participants Participants diagnosed with mRCC who received TKI as first line treatment, prescribed by physician, in real world practice were observed in this study.
Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up Interruptions in Cycle 1 · 0	76 Participants
Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up Interruptions in Cycle 1 · 1	25 Participants
Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up Interruptions in Cycle 1 · 2	0 Participants
Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up Interruptions in Cycle 1 · 3	0 Participants
Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up Interruptions in Cycle 1 · 4	0 Participants
Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up Interruptions in Cycle 2 · 0	73 Participants
Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up Interruptions in Cycle 2 · 1	16 Participants
Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up Interruptions in Cycle 2 · 2	5 Participants
Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up Interruptions in Cycle 2 · 3	0 Participants
Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up Interruptions in Cycle 2 · 4	0 Participants
Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up Interruptions in Cycle 3 · 0	59 Participants
Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up Interruptions in Cycle 3 · 1	9 Participants
Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up Interruptions in Cycle 3 · 2	3 Participants
Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up Interruptions in Cycle 3 · 3	0 Participants
Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up Interruptions in Cycle 3 · 4	0 Participants
Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up Interruptions in Cycle 4 · 0	58 Participants
Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up Interruptions in Cycle 4 · 1	7 Participants
Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up Interruptions in Cycle 4 · 2	2 Participants
Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up Interruptions in Cycle 4 · 3	0 Participants
Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up Interruptions in Cycle 4 · 4	0 Participants
Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up Interruptions in Cycle 5 · 0	39 Participants
Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up Interruptions in Cycle 5 · 1	12 Participants
Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up Interruptions in Cycle 5 · 2	2 Participants
Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up Interruptions in Cycle 5 · 3	1 Participants
Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up Interruptions in Cycle 5 · 4	0 Participants
Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up Interruptions in Cycle 6 · 0	41 Participants
Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up Interruptions in Cycle 6 · 1	10 Participants
Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up Interruptions in Cycle 6 · 2	1 Participants
Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up Interruptions in Cycle 6 · 3	0 Participants
Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up Interruptions in Cycle 6 · 4	0 Participants

PRIMARY outcome

Timeframe: From start of treatment with TKI until first documented best response of CR, PR, SD or DP (approximately maximum up to 3.8 years)

Population: Analysis population included all eligible participants who were included in this study.

Best response was recorded from start of treatment with TKI until best complete response (CR), partial response (PR), stable disease (SD) or disease progression (DP) was achieved. RECIST v1.1, a) CR: disappearance of all lesions; any pathological lymph nodes (target lesions \[TLs\]) or non-target lesions (non-TLs) must have reduction in short axis to \<10 mm; normalization of tumor marker level for non-TLs; b) PR: \>=30% decrease in sum of diameter of all TLs, taking as reference baseline sum of diameters; c) DP: \>=20% increase in sum of diameter of all TLs, taking as reference the smallest sum on study (including baseline measurement), sum must also be absolute increase of \>=5 mm. Unequivocal progression of existing non TLs. Appearance of at least 1 new lesion; d) SD: neither sufficient shrinkage to qualify for PR nor sufficient increase in lesions to qualify for PD referring smallest sum diameter. Participant whose best response was not determined were classified as "Undetermined".

Outcome measures

Outcome measures
Measure	Tyrosine Kinase Inhibitor n=111 Participants Participants diagnosed with mRCC who received TKI as first line treatment, prescribed by physician, in real world practice were observed in this study.
Number of Participants With Best Response Per Response Evaluation Criteria for Solid Tumours Version 1.1. (RECIST v1.1) CR	0 Participants
Number of Participants With Best Response Per Response Evaluation Criteria for Solid Tumours Version 1.1. (RECIST v1.1) PR	42 Participants
Number of Participants With Best Response Per Response Evaluation Criteria for Solid Tumours Version 1.1. (RECIST v1.1) SD	29 Participants
Number of Participants With Best Response Per Response Evaluation Criteria for Solid Tumours Version 1.1. (RECIST v1.1) DP	28 Participants
Number of Participants With Best Response Per Response Evaluation Criteria for Solid Tumours Version 1.1. (RECIST v1.1) Undetermined	12 Participants

PRIMARY outcome

Timeframe: From start of treatment till end of treatment (approximately maximum up to 3.8 years)

Population: Analysis population included all eligible participants who were included in this study.

In this outcome measure, the mean duration of treatment was calculated and reported below.

Outcome measures

Outcome measures
Measure	Tyrosine Kinase Inhibitor n=111 Participants Participants diagnosed with mRCC who received TKI as first line treatment, prescribed by physician, in real world practice were observed in this study.
Mean Duration of Treatment	8.9 Months Standard Deviation 7.7

PRIMARY outcome

Timeframe: From start of treatment with a TKI to tumour progression, treatment discontinuation for any reason or death from any cause or till follow-up in case of no event (approximately maximum up to 3.8 years)

Population: Analysis population included all eligible participants who were included in this study.

TTF was defined as the time from the start of treatment with a TKI to tumour progression, treatment discontinuation for any reason or death from any cause. Participants who did not had the event were censored on the date of their final follow-up. Per RECIST 1.1, tumour progression: \>=20% increase in sum of diameter of all measured target lesions, taking as reference smallest sum on study (including baseline measurement) of diameter of all target lesions, sum must also demonstrate an absolute increase of \>=5 mm. Unequivocal progression of existing non target lesions. Appearance of at least 1 new lesion.

Outcome measures

Outcome measures
Measure	Tyrosine Kinase Inhibitor n=111 Participants Participants diagnosed with mRCC who received TKI as first line treatment, prescribed by physician, in real world practice were observed in this study.
Time to Treatment Failure (TTF) After Initiation of Tyrosine Kinase Inhibitor Therapy	6.9 Months Interval 4.6 to 9.2

PRIMARY outcome

Timeframe: From start of treatment till end of treatment (approximately maximum up to 3.8 years)

Population: Analysis population included all eligible participants who were included in this study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

In this outcome measure, number of participants were classified according to number of treatment cycles received.

Outcome measures

Outcome measures
Measure	Tyrosine Kinase Inhibitor n=88 Participants Participants diagnosed with mRCC who received TKI as first line treatment, prescribed by physician, in real world practice were observed in this study.
Number of Participants Categorized According to Number of Treatment Cycles Received 12 cycles	1 Participants
Number of Participants Categorized According to Number of Treatment Cycles Received 13 cycles	1 Participants
Number of Participants Categorized According to Number of Treatment Cycles Received 14 cycles	2 Participants
Number of Participants Categorized According to Number of Treatment Cycles Received 15 cycles	1 Participants
Number of Participants Categorized According to Number of Treatment Cycles Received 17 cycles	1 Participants
Number of Participants Categorized According to Number of Treatment Cycles Received 19 cycles	1 Participants
Number of Participants Categorized According to Number of Treatment Cycles Received 25 cycles	1 Participants
Number of Participants Categorized According to Number of Treatment Cycles Received 0 cycles	2 Participants
Number of Participants Categorized According to Number of Treatment Cycles Received 1 cycle	10 Participants
Number of Participants Categorized According to Number of Treatment Cycles Received 2 cycles	21 Participants
Number of Participants Categorized According to Number of Treatment Cycles Received 3 cycles	8 Participants
Number of Participants Categorized According to Number of Treatment Cycles Received 4 cycles	12 Participants
Number of Participants Categorized According to Number of Treatment Cycles Received 5 cycles	3 Participants
Number of Participants Categorized According to Number of Treatment Cycles Received 6 cycles	4 Participants
Number of Participants Categorized According to Number of Treatment Cycles Received 7 cycles	9 Participants
Number of Participants Categorized According to Number of Treatment Cycles Received 8 cycles	5 Participants
Number of Participants Categorized According to Number of Treatment Cycles Received 9 cycles	1 Participants
Number of Participants Categorized According to Number of Treatment Cycles Received 10 cycles	4 Participants
Number of Participants Categorized According to Number of Treatment Cycles Received 11 cycles	1 Participants

PRIMARY outcome

Timeframe: From start of treatment with a TKI to tumour progression or death for any reason or till follow-up in case of no event (approximately maximum up to 3.8 years)

Population: Analysis population included all eligible participants who were included in this study.

PFS was defined as the time from the start of treatment with a TKI to tumour progression or death for any reason. Participants who, did not had the event were censored on the date of their final follow-up. Per RECIST v1.1, tumour progression: \>=20% increase in sum of diameter of all measured target lesions, taking as reference smallest sum on study (including baseline measurement) of diameter of all target lesions, sum must also demonstrate an absolute increase of \>=5 mm. Unequivocal progression of existing non target lesions. Appearance of at least 1 new lesion.

Outcome measures

Outcome measures
Measure	Tyrosine Kinase Inhibitor n=111 Participants Participants diagnosed with mRCC who received TKI as first line treatment, prescribed by physician, in real world practice were observed in this study.
Progression-Free Survival (PFS)	9.3 Months Interval 6.2 to 10.9

PRIMARY outcome

Timeframe: From start of treatment with TKI until first documented CR or PR (approximately maximum up to 3.8 years)

Population: Analysis population included all eligible participants who were included in this study.

ORR was defined as the percentage of participants who achieved CR or PR. Per RECIST V1.1, a) CR: disappearance of all lesions; any pathological lymph nodes (target lesions or non-target lesions) must have reduction in short axis to \<10 mm; normalization of tumor marker level for non-TLs; b) PR: \>=30% decrease in sum of diameter of all target lesions, taking as reference baseline sum of diameters.

Outcome measures

Outcome measures
Measure	Tyrosine Kinase Inhibitor n=111 Participants Participants diagnosed with mRCC who received TKI as first line treatment, prescribed by physician, in real world practice were observed in this study.
Objective Response Rate (ORR)	37.8 Percentage of participants

PRIMARY outcome

Timeframe: From day of documented CR or PR to the first day that DP was observed (approximately maximum up to 3.8 years)

Population: Analysis population included all eligible participants who were included in this study. Here 'Overall Number of Participants Analyzed' signifies participants with documented CR or PR.

In participants who achieved CR or PR, DOR was defined as the duration from the documentation date of CR or PR to the first day when DP was observed. Per RECIST V1.1, a) CR: disappearance of all lesions; any pathological lymph nodes (target lesions or non-target lesions must have reduction in short axis to \<10 mm; normalization of tumor marker level for non-target lesions; b) PR: \>=30% decrease in sum of diameter of all target lesions, taking as reference baseline sum of diameters; c) DP: \>=20% increase in sum of diameter of all measured target lesions, taking as reference smallest sum on study (including baseline measurement), sum must also demonstrate an absolute increase of \>=5 mm. Unequivocal progression of existing non TLs. Appearance of at least 1 new lesion.

Outcome measures

Outcome measures
Measure	Tyrosine Kinase Inhibitor n=42 Participants Participants diagnosed with mRCC who received TKI as first line treatment, prescribed by physician, in real world practice were observed in this study.
Duration of Response (DOR)	11.8 Months Standard Deviation 7.3

PRIMARY outcome

Timeframe: During 9 months

Population: Analysis population included all eligible participants who were included in this study. Here, "Overall Number of Participants Analyzed" signifies participants with fatigue event.

An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per CTCAE version 4, Grade 1= mild AE; Grade 2= moderate AE; Grade 3= severe AE; Grade 4= life-threatening or disabling AE; Grade 5= death related to an AE. In this outcome measure number of participants with fatigue event were classified into following: CTCAE grade 1 to 2 and CTCAE grade 3 to 4.

Outcome measures

Outcome measures
Measure	Tyrosine Kinase Inhibitor n=6 Participants Participants diagnosed with mRCC who received TKI as first line treatment, prescribed by physician, in real world practice were observed in this study.
Number of Participants With Fatigue Event Graded Per Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 Grade 1-2	6 Participants
Number of Participants With Fatigue Event Graded Per Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 Grade 3-4	0 Participants

PRIMARY outcome

Timeframe: During 9 months

Population: Analysis population included all eligible participants who were included in this study. Here, "Overall Number of Participants Analyzed" signifies participants with hand foot syndrome event.

An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per CTCAE version 4, Grade 1= mild AE; Grade 2= moderate AE; Grade 3= severe AE; Grade 4= life-threatening or disabling AE; Grade 5= death related to an AE. In this outcome measure number of participants with hand foot syndrome event were classified into following: CTCAE grade 1 to 2 and CTCAE grade 3 to 4.

Outcome measures

Outcome measures
Measure	Tyrosine Kinase Inhibitor n=32 Participants Participants diagnosed with mRCC who received TKI as first line treatment, prescribed by physician, in real world practice were observed in this study.
Number of Participants With Hand Foot Syndrome Event Graded Per Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 Grade 1-2	30 Participants
Number of Participants With Hand Foot Syndrome Event Graded Per Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 Grade 3-4	2 Participants

PRIMARY outcome

Timeframe: Week 12

Population: Analysis population included all eligible participants who were included in this study. Here, 'Overall Number of Participants Analyzed' signifies participants with HFS event at Week 12.

AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per CTCAE version 4, Grade 1= mild AE; Grade 2= moderate AE; Grade 3= severe AE; Grade 4= life-threatening or disabling AE; Grade 5= death related to an AE. In this outcome measure number of participants with HFS event graded per CTCAE version 4.0 at Week 12 are reported.

Outcome measures

Outcome measures
Measure	Tyrosine Kinase Inhibitor n=19 Participants Participants diagnosed with mRCC who received TKI as first line treatment, prescribed by physician, in real world practice were observed in this study.
Number of Participants With Palmar-Plantar Erythrodysaesthesia (HFS) Event Graded Per CTCAE Version 4.0 at Week 12 Grade 1	11 Participants
Number of Participants With Palmar-Plantar Erythrodysaesthesia (HFS) Event Graded Per CTCAE Version 4.0 at Week 12 Grade 2	7 Participants
Number of Participants With Palmar-Plantar Erythrodysaesthesia (HFS) Event Graded Per CTCAE Version 4.0 at Week 12 Grade 3	1 Participants

PRIMARY outcome

Timeframe: Week 24

Population: Analysis population included all eligible participants who were included in this study. Here, 'Overall Number of Participants Analyzed' signifies participants with HFS event at Week 24.

AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per CTCAE version 4, Grade 1= mild AE; Grade 2= moderate AE; Grade 3= severe AE; Grade 4= life-threatening or disabling AE; Grade 5= death related to an AE. In this outcome measure number of participants with HFS event graded per CTCAE version 4.0 at Week 24 are reported.

Outcome measures

Outcome measures
Measure	Tyrosine Kinase Inhibitor n=14 Participants Participants diagnosed with mRCC who received TKI as first line treatment, prescribed by physician, in real world practice were observed in this study.
Number of Participants With Palmar-Plantar Erythrodysaesthesia (HFS) Event Graded Per CTCAE Version 4.0 at Week 24 Grade 1	11 Participants
Number of Participants With Palmar-Plantar Erythrodysaesthesia (HFS) Event Graded Per CTCAE Version 4.0 at Week 24 Grade 2	2 Participants
Number of Participants With Palmar-Plantar Erythrodysaesthesia (HFS) Event Graded Per CTCAE Version 4.0 at Week 24 Grade 3	1 Participants

PRIMARY outcome

Timeframe: Week 36

Population: Analysis population included all eligible participants who were included in this study. Here, 'Overall Number of Participants Analyzed' signifies participants with HFS event at Week 36.

AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per CTCAE version 4, Grade 1= mild AE; Grade 2= moderate AE; Grade 3= severe AE; Grade 4= life-threatening or disabling AE; Grade 5= death related to an AE. In this outcome measure number of participants with HFS event graded per CTCAE version 4.0 at Week 36 are reported.

Outcome measures

Outcome measures
Measure	Tyrosine Kinase Inhibitor n=10 Participants Participants diagnosed with mRCC who received TKI as first line treatment, prescribed by physician, in real world practice were observed in this study.
Number of Participants With Palmar-Plantar Erythrodysaesthesia (HFS) Event Graded Per CTCAE Version 4.0 at Week 36 Grade 1	8 Participants
Number of Participants With Palmar-Plantar Erythrodysaesthesia (HFS) Event Graded Per CTCAE Version 4.0 at Week 36 Grade 2	1 Participants
Number of Participants With Palmar-Plantar Erythrodysaesthesia (HFS) Event Graded Per CTCAE Version 4.0 at Week 36 Grade 3	1 Participants

Adverse Events

Sunitinib

Serious events: 23 serious events

Other events: 82 other events

Deaths: 17 deaths

Pazopanib

Serious events: 5 serious events

Other events: 6 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

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

Measure	Sunitinib n=100 participants at risk Participants diagnosed with mRCC who received either 4/2 regimen or 2/1 regimen of 50 mg or 37.5 mg or 25 mg dose of Sunitinib as first line treatment, prescribed by physician, in real world practice were observed in this study. "2/1" regimen meant 14 days on drug and 7 days without drug. "4/2" regimen meant 28 days on drug and 14 days without drug.	Pazopanib n=11 participants at risk Participants diagnosed with mRCC who received 800 mg of Pazopanib per 24 hours continuously as first line treatment, prescribed by physician, in real world practice were observed in this study.
Hepatobiliary disorders Hepatotoxicity	0.00% 0/100 • From start of treatment till end of treatment (approximately maximum up to 3.8 years) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Analysis population included all eligible participants whose data was collected and analyzed in this study.	9.1% 1/11 • From start of treatment till end of treatment (approximately maximum up to 3.8 years) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Analysis population included all eligible participants whose data was collected and analyzed in this study.
Renal and urinary disorders Renal failure	1.0% 1/100 • From start of treatment till end of treatment (approximately maximum up to 3.8 years) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Analysis population included all eligible participants whose data was collected and analyzed in this study.	9.1% 1/11 • From start of treatment till end of treatment (approximately maximum up to 3.8 years) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Analysis population included all eligible participants whose data was collected and analyzed in this study.
Cardiac disorders Cardiotoxicity	1.0% 1/100 • From start of treatment till end of treatment (approximately maximum up to 3.8 years) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Analysis population included all eligible participants whose data was collected and analyzed in this study.	0.00% 0/11 • From start of treatment till end of treatment (approximately maximum up to 3.8 years) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Analysis population included all eligible participants whose data was collected and analyzed in this study.
Blood and lymphatic system disorders Neutropenia	6.0% 6/100 • From start of treatment till end of treatment (approximately maximum up to 3.8 years) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Analysis population included all eligible participants whose data was collected and analyzed in this study.	0.00% 0/11 • From start of treatment till end of treatment (approximately maximum up to 3.8 years) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Analysis population included all eligible participants whose data was collected and analyzed in this study.
Blood and lymphatic system disorders Thrombocytopenia	5.0% 5/100 • From start of treatment till end of treatment (approximately maximum up to 3.8 years) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Analysis population included all eligible participants whose data was collected and analyzed in this study.	0.00% 0/11 • From start of treatment till end of treatment (approximately maximum up to 3.8 years) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Analysis population included all eligible participants whose data was collected and analyzed in this study.
Gastrointestinal disorders Diarrhoea	1.0% 1/100 • From start of treatment till end of treatment (approximately maximum up to 3.8 years) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Analysis population included all eligible participants whose data was collected and analyzed in this study.	9.1% 1/11 • From start of treatment till end of treatment (approximately maximum up to 3.8 years) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Analysis population included all eligible participants whose data was collected and analyzed in this study.
Gastrointestinal disorders Oral mucosal disorder	1.0% 1/100 • From start of treatment till end of treatment (approximately maximum up to 3.8 years) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Analysis population included all eligible participants whose data was collected and analyzed in this study.	0.00% 0/11 • From start of treatment till end of treatment (approximately maximum up to 3.8 years) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Analysis population included all eligible participants whose data was collected and analyzed in this study.
Gastrointestinal disorders Vomiting	1.0% 1/100 • From start of treatment till end of treatment (approximately maximum up to 3.8 years) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Analysis population included all eligible participants whose data was collected and analyzed in this study.	0.00% 0/11 • From start of treatment till end of treatment (approximately maximum up to 3.8 years) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Analysis population included all eligible participants whose data was collected and analyzed in this study.
General disorders Asthenia	2.0% 2/100 • From start of treatment till end of treatment (approximately maximum up to 3.8 years) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Analysis population included all eligible participants whose data was collected and analyzed in this study.	9.1% 1/11 • From start of treatment till end of treatment (approximately maximum up to 3.8 years) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Analysis population included all eligible participants whose data was collected and analyzed in this study.
General disorders Mucosal inflammation	2.0% 2/100 • From start of treatment till end of treatment (approximately maximum up to 3.8 years) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Analysis population included all eligible participants whose data was collected and analyzed in this study.	0.00% 0/11 • From start of treatment till end of treatment (approximately maximum up to 3.8 years) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Analysis population included all eligible participants whose data was collected and analyzed in this study.
Hepatobiliary disorders Cholecystitis	1.0% 1/100 • From start of treatment till end of treatment (approximately maximum up to 3.8 years) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Analysis population included all eligible participants whose data was collected and analyzed in this study.	0.00% 0/11 • From start of treatment till end of treatment (approximately maximum up to 3.8 years) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Analysis population included all eligible participants whose data was collected and analyzed in this study.
Nervous system disorders Dysgeusia	0.00% 0/100 • From start of treatment till end of treatment (approximately maximum up to 3.8 years) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Analysis population included all eligible participants whose data was collected and analyzed in this study.	9.1% 1/11 • From start of treatment till end of treatment (approximately maximum up to 3.8 years) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Analysis population included all eligible participants whose data was collected and analyzed in this study.
Respiratory, thoracic and mediastinal disorders Pneumothorax	1.0% 1/100 • From start of treatment till end of treatment (approximately maximum up to 3.8 years) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Analysis population included all eligible participants whose data was collected and analyzed in this study.	0.00% 0/11 • From start of treatment till end of treatment (approximately maximum up to 3.8 years) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Analysis population included all eligible participants whose data was collected and analyzed in this study.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	2.0% 2/100 • From start of treatment till end of treatment (approximately maximum up to 3.8 years) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Analysis population included all eligible participants whose data was collected and analyzed in this study.	0.00% 0/11 • From start of treatment till end of treatment (approximately maximum up to 3.8 years) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Analysis population included all eligible participants whose data was collected and analyzed in this study.
Skin and subcutaneous tissue disorders Skin toxicity	1.0% 1/100 • From start of treatment till end of treatment (approximately maximum up to 3.8 years) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Analysis population included all eligible participants whose data was collected and analyzed in this study.	0.00% 0/11 • From start of treatment till end of treatment (approximately maximum up to 3.8 years) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Analysis population included all eligible participants whose data was collected and analyzed in this study.
Vascular disorders Hypertension	2.0% 2/100 • From start of treatment till end of treatment (approximately maximum up to 3.8 years) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Analysis population included all eligible participants whose data was collected and analyzed in this study.	0.00% 0/11 • From start of treatment till end of treatment (approximately maximum up to 3.8 years) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Analysis population included all eligible participants whose data was collected and analyzed in this study.