Trial Outcomes & Findings for Clinical Outcome Of Advanced Renal Cell Carcinoma In Taiwan (NCT NCT02776644)

NCT ID: NCT02776644

Last Updated: 2023-03-16

Results Overview

Treatment durations (in days) of Sunitinib and Pazopanib were calculated from the date of the first prescription to the last dose of Sunitinib and Pazopanib during the 11 year observation period.

• Recruitment status: COMPLETED
• Target enrollment: 1349 participants
• Primary outcome timeframe: during the observation period of 11 years
• Results posted on: 2023-03-16

Participant Flow

Participant milestones

Measure	Sunitinib Participants who were diagnosed with metastatic renal cell carcinoma (RCC), as per the records of Catastrophic illness patient database and National health insurance research database (NHIRD) (from January 2004 to December 2015), and were treated with Sunitinib capsule 12.5 milligram (mg), were included in this study and their data was observed retrospectively.	Pazopanib Participants who were diagnosed with metastatic RCC, as per the records of Catastrophic illness patient database and NHIRD (from January 2004 to December 2014), and were treated with Pazopanib tablets 200 mg, were included in this study and their data was observed retrospectively.
Overall Study STARTED	1223	126
Overall Study COMPLETED	1223	126
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Sunitinib n=1223 Participants Participants who were diagnosed with metastatic renal cell carcinoma (RCC), as per the records of Catastrophic illness patient database and National health insurance research database (NHIRD) (from January 2004 to December 2015), and were treated with Sunitinib capsule 12.5 milligram (mg), were included in this study and their data was observed retrospectively.	Pazopanib n=126 Participants Participants who were diagnosed with metastatic RCC, as per the records of Catastrophic illness patient database and NHIRD (from January 2004 to December 2014), and were treated with Pazopanib tablets 200 mg, were included in this study and their data was observed retrospectively.	Total n=1349 Participants Total of all reporting groups
Age, Continuous	64.14 years STANDARD_DEVIATION 13 • n=1223 Participants	66.45 years STANDARD_DEVIATION 12.95 • n=126 Participants	64.33 years STANDARD_DEVIATION 12.99 • n=1349 Participants
Sex/Gender, Customized Female	318 Participants n=1223 Participants	37 Participants n=126 Participants	355 Participants n=1349 Participants
Sex/Gender, Customized Male	903 Participants n=1223 Participants	89 Participants n=126 Participants	992 Participants n=1349 Participants
Sex/Gender, Customized Unknown	2 Participants n=1223 Participants	0 Participants n=126 Participants	2 Participants n=1349 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Participants by Different Income Levels Low income	279 Participants n=1223 Participants	24 Participants n=126 Participants	303 Participants n=1349 Participants
Participants by Different Income Levels Medium income	351 Participants n=1223 Participants	37 Participants n=126 Participants	388 Participants n=1349 Participants
Participants by Different Income Levels High income	593 Participants n=1223 Participants	65 Participants n=126 Participants	658 Participants n=1349 Participants
Participants With Different Co-Morbid Conditions Hypertension	634 Participants n=1223 Participants	59 Participants n=126 Participants	693 Participants n=1349 Participants
Participants With Different Co-Morbid Conditions Diabetes mellitus	350 Participants n=1223 Participants	39 Participants n=126 Participants	389 Participants n=1349 Participants
Participants With Different Co-Morbid Conditions Dyslipidemia	312 Participants n=1223 Participants	32 Participants n=126 Participants	344 Participants n=1349 Participants
Participants With Different Co-Morbid Conditions Coronary artery disease	188 Participants n=1223 Participants	30 Participants n=126 Participants	218 Participants n=1349 Participants
Participants With Different Co-Morbid Conditions Chronic kidney disease	159 Participants n=1223 Participants	17 Participants n=126 Participants	176 Participants n=1349 Participants
Participants With Different Co-Morbid Conditions Liver cirrhosis	26 Participants n=1223 Participants	NA Participants n=126 Participants	NA Participants n=1349 Participants
Participants Who Had Received Concomitant-Medications Beta blockers	364 Participants n=1223 Participants	38 Participants n=126 Participants	402 Participants n=1349 Participants
Participants Who Had Received Concomitant-Medications Calcium channel blockers	543 Participants n=1223 Participants	57 Participants n=126 Participants	600 Participants n=1349 Participants
Participants Who Had Received Concomitant-Medications Diuretics	331 Participants n=1223 Participants	38 Participants n=126 Participants	369 Participants n=1349 Participants
Participants Who Had Received Concomitant-Medications Angiotensin-converting enzyme inhibitors	135 Participants n=1223 Participants	11 Participants n=126 Participants	146 Participants n=1349 Participants
Participants Who Had Received Concomitant-Medications Angiotensin receptor blocker	397 Participants n=1223 Participants	40 Participants n=126 Participants	437 Participants n=1349 Participants
Participants Who Had Received Concomitant-Medications Insulin	53 Participants n=1223 Participants	7 Participants n=126 Participants	60 Participants n=1349 Participants
Participants Who Had Received Concomitant-Medications Biguanides	189 Participants n=1223 Participants	22 Participants n=126 Participants	211 Participants n=1349 Participants
Participants Who Had Received Concomitant-Medications Sulfonylurea	186 Participants n=1223 Participants	16 Participants n=126 Participants	202 Participants n=1349 Participants
Participants Who Had Received Concomitant-Medications Glucosidase inhibitors	56 Participants n=1223 Participants	4 Participants n=126 Participants	60 Participants n=1349 Participants
Participants Who Had Received Concomitant-Medications Thiazolidinediones	46 Participants n=1223 Participants	NA Participants n=126 Participants	NA Participants n=1349 Participants
Participants Who Had Received Concomitant-Medications Dipeptidyl peptidase 4 inhibitors	80 Participants n=1223 Participants	19 Participants n=126 Participants	99 Participants n=1349 Participants
Participants Who Had Received Concomitant-Medications Statins	242 Participants n=1223 Participants	27 Participants n=126 Participants	269 Participants n=1349 Participants
Participants Who Had Received Concomitant-Medications Fibrates	56 Participants n=1223 Participants	6 Participants n=126 Participants	62 Participants n=1349 Participants
Participants Who Had Received Concomitant-Medications Bile acid sequestrants and Nicotinic acid	4 Participants n=1223 Participants	NA Participants n=126 Participants	NA Participants n=1349 Participants
Participants Who Had Received Concomitant-Medications Ezetimibe	18 Participants n=1223 Participants	NA Participants n=126 Participants	NA Participants n=1349 Participants
Participants Who Had Received Concomitant-Medications Antiplatelets	352 Participants n=1223 Participants	34 Participants n=126 Participants	386 Participants n=1349 Participants
Participants Who Had Received Concomitant-Medications Anticoagulants	32 Participants n=1223 Participants	NA Participants n=126 Participants	NA Participants n=1349 Participants
Participants Admitted/Visited to Hospital by Type of Hospitals Medical center	865 Participants n=1223 Participants	91 Participants n=126 Participants	956 Participants n=1349 Participants
Participants Admitted/Visited to Hospital by Type of Hospitals Other than medical center	358 Participants n=1223 Participants	35 Participants n=126 Participants	393 Participants n=1349 Participants
Participants Admitted/Visited to the Hospital According to the Geographical Location of Hospitals Capital area hospital	447 Participants n=1223 Participants	40 Participants n=126 Participants	487 Participants n=1349 Participants
Participants Admitted/Visited to the Hospital According to the Geographical Location of Hospitals Non-capital area hospital	776 Participants n=1223 Participants	86 Participants n=126 Participants	862 Participants n=1349 Participants

PRIMARY outcome

Timeframe: during the observation period of 11 years

Population: All Taiwanese participants diagnosed with metastatic RCC during the time period of January 2004 to December 2015 and received treatment (Sunitinib or Pazopanib).

Treatment durations (in days) of Sunitinib and Pazopanib were calculated from the date of the first prescription to the last dose of Sunitinib and Pazopanib during the 11 year observation period.

Outcome measures

Measure	Sunitinib n=1223 Participants Participants who were diagnosed with metastatic renal cell carcinoma (RCC), as per the records of Catastrophic illness patient database and National health insurance research database (NHIRD) (from January 2004 to December 2015), and were treated with Sunitinib capsule 12.5 milligram (mg), were included in this study and their data was observed retrospectively.	Pazopanib n=126 Participants Participants who were diagnosed with metastatic RCC, as per the records of Catastrophic illness patient database and NHIRD (from January 2004 to December 2014), and were treated with Pazopanib tablets 200 mg, were included in this study and their data was observed retrospectively.
Duration of Sunitinib and Pazopanib Treatment in Participants	171 days Interval 1.0 to 2153.0	114.5 days Interval 1.0 to 1219.0

PRIMARY outcome

Timeframe: from the time of start of treatment up to Month 3

Population: All Taiwanese participants diagnosed with metastatic RCC during the time period of January 2004 to December 2015 and received treatment (Sunitinib or Pazopanib).

The cumulative number of Sunitinib and Pazopanib capsules which were given to the participants from the time of start of treatment up to Month 3 were reported here.

Outcome measures

Measure	Sunitinib n=1223 Participants Participants who were diagnosed with metastatic renal cell carcinoma (RCC), as per the records of Catastrophic illness patient database and National health insurance research database (NHIRD) (from January 2004 to December 2015), and were treated with Sunitinib capsule 12.5 milligram (mg), were included in this study and their data was observed retrospectively.	Pazopanib n=126 Participants Participants who were diagnosed with metastatic RCC, as per the records of Catastrophic illness patient database and NHIRD (from January 2004 to December 2014), and were treated with Pazopanib tablets 200 mg, were included in this study and their data was observed retrospectively.
Cumulative Number of Capsules of Sunitinib and Pazopanib Administered From the Time of Start of Treatment Up to Month 3	190.1 capsules Standard Deviation 81.5	215.1 capsules Standard Deviation 118.4

PRIMARY outcome

Timeframe: Month 3 up to Month 6

Population: All Taiwanese participants diagnosed with metastatic RCC during the time period of January 2004 to December 2015 and received treatment (Sunitinib or Pazopanib).

The cumulative number of Sunitinib and Pazopanib capsules which were given to the participants from Month 3 (after the start of treatment) to Month 6 were reported here.

Outcome measures

Measure	Sunitinib n=1223 Participants Participants who were diagnosed with metastatic renal cell carcinoma (RCC), as per the records of Catastrophic illness patient database and National health insurance research database (NHIRD) (from January 2004 to December 2015), and were treated with Sunitinib capsule 12.5 milligram (mg), were included in this study and their data was observed retrospectively.	Pazopanib n=126 Participants Participants who were diagnosed with metastatic RCC, as per the records of Catastrophic illness patient database and NHIRD (from January 2004 to December 2014), and were treated with Pazopanib tablets 200 mg, were included in this study and their data was observed retrospectively.
Cumulative Number of Capsules of Sunitinib and Pazopanib Administered From Month 3 to Month 6	165.0 capsules Standard Deviation 88.4	193.2 capsules Standard Deviation 118.9

PRIMARY outcome

Timeframe: Month 6 up to Month 9

Population: All Taiwanese participants diagnosed with metastatic RCC during the time period of January 2004 to December 2015 and received treatment (Sunitinib or Pazopanib).

The cumulative number of Sunitinib and Pazopanib capsules which were given to the participants from Month 6 (after the start of treatment) to Month 9 were reported here.

Outcome measures

Measure	Sunitinib n=1223 Participants Participants who were diagnosed with metastatic renal cell carcinoma (RCC), as per the records of Catastrophic illness patient database and National health insurance research database (NHIRD) (from January 2004 to December 2015), and were treated with Sunitinib capsule 12.5 milligram (mg), were included in this study and their data was observed retrospectively.	Pazopanib n=126 Participants Participants who were diagnosed with metastatic RCC, as per the records of Catastrophic illness patient database and NHIRD (from January 2004 to December 2014), and were treated with Pazopanib tablets 200 mg, were included in this study and their data was observed retrospectively.
Cumulative Number of Capsules of Sunitinib and Pazopanib Administered From Month 6 to Month 9	174.9 capsules Standard Deviation 83.5	186.5 capsules Standard Deviation 111.1

PRIMARY outcome

Timeframe: Month 9 up to Month 12

Population: All Taiwanese participants diagnosed with metastatic RCC during the time period of January 2004 to December 2015 and received treatment (Sunitinib or Pazopanib).

The cumulative number of Sunitinib and Pazopanib capsules which were given to the participants from Month 9 (after the start of treatment) to Month 12 were reported here.

Outcome measures

Measure	Sunitinib n=1223 Participants Participants who were diagnosed with metastatic renal cell carcinoma (RCC), as per the records of Catastrophic illness patient database and National health insurance research database (NHIRD) (from January 2004 to December 2015), and were treated with Sunitinib capsule 12.5 milligram (mg), were included in this study and their data was observed retrospectively.	Pazopanib n=126 Participants Participants who were diagnosed with metastatic RCC, as per the records of Catastrophic illness patient database and NHIRD (from January 2004 to December 2014), and were treated with Pazopanib tablets 200 mg, were included in this study and their data was observed retrospectively.
Cumulative Number of Capsules of Sunitinib and Pazopanib Administered From Month 9 to Month 12	176.5 capsules Standard Deviation 83.4	212.1 capsules Standard Deviation 109.9

PRIMARY outcome

Timeframe: from the time of start of treatment up to Month 12

Population: All Taiwanese participants diagnosed with metastatic RCC during the time period of January 2004 to December 2015 and received treatment (Sunitinib or Pazopanib).

The cumulative number of Sunitinib and Pazopanib capsules which were given to the participants from the time of start of treatment to Month 12 were reported here.

Outcome measures

Measure	Sunitinib n=1223 Participants Participants who were diagnosed with metastatic renal cell carcinoma (RCC), as per the records of Catastrophic illness patient database and National health insurance research database (NHIRD) (from January 2004 to December 2015), and were treated with Sunitinib capsule 12.5 milligram (mg), were included in this study and their data was observed retrospectively.	Pazopanib n=126 Participants Participants who were diagnosed with metastatic RCC, as per the records of Catastrophic illness patient database and NHIRD (from January 2004 to December 2014), and were treated with Pazopanib tablets 200 mg, were included in this study and their data was observed retrospectively.
Cumulative Number of Capsules of Sunitinib and Pazopanib Administered From the Time of Start of Treatment Up to Month 12	435.4 capsules Standard Deviation 326.8	438.0 capsules Standard Deviation 375.1

PRIMARY outcome

Timeframe: from the time of disease diagnosis till the first dose of Sunitinib and Pazopanib

Population: All Taiwanese participants diagnosed with metastatic RCC during the time period of January 2004 to December 2015 and received treatment (Sunitinib or Pazopanib). Overall number of participants analyzed signifies participants who were evaluable for this outcome measure.

Direct medical costs include the cost of the Sunitinib or Pazopanib and all follow-up costs for other medication and health care interventions in ambulatory, inpatient, and nursing care. All specialist and general practitioner care, including emergency care, as well as rehabilitation and physiotherapy.

Outcome measures

Measure	Sunitinib n=1221 Participants Participants who were diagnosed with metastatic renal cell carcinoma (RCC), as per the records of Catastrophic illness patient database and National health insurance research database (NHIRD) (from January 2004 to December 2015), and were treated with Sunitinib capsule 12.5 milligram (mg), were included in this study and their data was observed retrospectively.	Pazopanib n=126 Participants Participants who were diagnosed with metastatic RCC, as per the records of Catastrophic illness patient database and NHIRD (from January 2004 to December 2014), and were treated with Pazopanib tablets 200 mg, were included in this study and their data was observed retrospectively.
Overall Renal Cell Carcinoma (RCC) Related Direct Medical Cost From the Diagnosis Date to the First Dose of Sunitinib and Pazopanib	176,969,380 new Taiwan dollars	45,442,288 new Taiwan dollars

PRIMARY outcome

Timeframe: From first dose of drug to the end of observation period (up to 11 years)

Population: All Taiwanese participants diagnosed with metastatic RCC during the time period of January 2004 to December 2015 and received treatment (Sunitinib or Pazopanib). Overall number of participants analyzed signifies participants who were evaluable for this outcome measure.

Direct medical costs include the cost of the Sunitinib or Pazopanib and all follow-up costs for other medication and health care interventions in ambulatory, inpatient, and nursing care. All specialist and general practitioner care, including emergency care, as well as rehabilitation and physiotherapy.

Outcome measures

Measure	Sunitinib n=1221 Participants Participants who were diagnosed with metastatic renal cell carcinoma (RCC), as per the records of Catastrophic illness patient database and National health insurance research database (NHIRD) (from January 2004 to December 2015), and were treated with Sunitinib capsule 12.5 milligram (mg), were included in this study and their data was observed retrospectively.	Pazopanib n=126 Participants Participants who were diagnosed with metastatic RCC, as per the records of Catastrophic illness patient database and NHIRD (from January 2004 to December 2014), and were treated with Pazopanib tablets 200 mg, were included in this study and their data was observed retrospectively.
Overall Renal Cell Carcinoma (RCC) Related Direct Medical Cost From the First Dose of the Sunitinib and Pazopanib to the End of Observation Period	1,519,649,383 new Taiwan dollars	78,745,896 new Taiwan dollars

PRIMARY outcome

Timeframe: from the time of first prescription of Sunitinib or Pazopanib till date of death (during the observation period of 11 years)

Population: All Taiwanese participants diagnosed with metastatic RCC during the time period of January 2004 to December 2015 and received treatment (Sunitinib or Pazopanib).

Overall survival of participants was defined as time (in days) between date of prescribing treatment (Sunitinib or Pazopanib) till date of death.

Outcome measures

Measure	Sunitinib n=1223 Participants Participants who were diagnosed with metastatic renal cell carcinoma (RCC), as per the records of Catastrophic illness patient database and National health insurance research database (NHIRD) (from January 2004 to December 2015), and were treated with Sunitinib capsule 12.5 milligram (mg), were included in this study and their data was observed retrospectively.	Pazopanib n=126 Participants Participants who were diagnosed with metastatic RCC, as per the records of Catastrophic illness patient database and NHIRD (from January 2004 to December 2014), and were treated with Pazopanib tablets 200 mg, were included in this study and their data was observed retrospectively.
Overall Survival	490 days Interval 443.0 to 536.0	416 days Interval 312.0 to 807.0

PRIMARY outcome

Timeframe: time of first dose of the drug, Month 1

Population: All Taiwanese participants diagnosed with metastatic RCC during the time period of January 2004 to December 2015 and received treatment (Sunitinib or Pazopanib). Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure.

Changes in the prescription patterns of antihypertensive medication were categorized as: 1) Unchanged: no change in the count/number of capsules or class(es) of the antihypertensive medication at Month 1 as compared to the time of first dose, 2) Increased: increase in counts/number of capsules of the ongoing class(es) of the antihypertensive medication at Month 1 as compared to the time of first dose, 3) Decreased: Decrease in the counts/number of capsules of ongoing class(es) of antihypertensive medication at Month 1 as compared to the time of first dose, 4) Switched: shifted to other class(es) of antihypertensive medication without changes in counts of antihypertensive medication at Month 1 as compared to the time of first dose. The number of participants with change in prescription patterns based on the specified categories is reported.

Outcome measures

Measure	Sunitinib n=189 Participants Participants who were diagnosed with metastatic renal cell carcinoma (RCC), as per the records of Catastrophic illness patient database and National health insurance research database (NHIRD) (from January 2004 to December 2015), and were treated with Sunitinib capsule 12.5 milligram (mg), were included in this study and their data was observed retrospectively.	Pazopanib n=43 Participants Participants who were diagnosed with metastatic RCC, as per the records of Catastrophic illness patient database and NHIRD (from January 2004 to December 2014), and were treated with Pazopanib tablets 200 mg, were included in this study and their data was observed retrospectively.
Number of Participants With Changes in Prescription Patterns of Antihypertensive Medication From the Time of First Dose of Drug at Month 1 Switched	35 Participants	6 Participants
Number of Participants With Changes in Prescription Patterns of Antihypertensive Medication From the Time of First Dose of Drug at Month 1 Unchanged	96 Participants	9 Participants
Number of Participants With Changes in Prescription Patterns of Antihypertensive Medication From the Time of First Dose of Drug at Month 1 Increased	85 Participants	14 Participants
Number of Participants With Changes in Prescription Patterns of Antihypertensive Medication From the Time of First Dose of Drug at Month 1 Decreased	63 Participants	14 Participants

PRIMARY outcome

Timeframe: time of first dose of the drug, Month 3

Population: All Taiwanese participants diagnosed with metastatic RCC during the time period of January 2004 to December 2015 and received treatment (Sunitinib or Pazopanib). Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure.

Changes in the prescription patterns of antihypertensive medication were categorized as: 1) Unchanged: no change in the count/number of capsules or class(es) of the antihypertensive medication at Month 3 as compared to the time of first dose, 2) Increased: increase in counts/number of capsules of the ongoing class(es) of the antihypertensive medication at Month 3 as compared to the time of first dose, 3) Decreased: Decrease in the counts/number of capsules of ongoing class(es) of antihypertensive medication at Month 3 as compared to the time of first dose, 4) Switched: shifted to other class(es) of antihypertensive medication without changes in counts of antihypertensive medication at Month 3 as compared to the time of first dose. The number of participants with change in prescription patterns based on the specified categories is reported.

Outcome measures

Measure	Sunitinib n=421 Participants Participants who were diagnosed with metastatic renal cell carcinoma (RCC), as per the records of Catastrophic illness patient database and National health insurance research database (NHIRD) (from January 2004 to December 2015), and were treated with Sunitinib capsule 12.5 milligram (mg), were included in this study and their data was observed retrospectively.	Pazopanib n=61 Participants Participants who were diagnosed with metastatic RCC, as per the records of Catastrophic illness patient database and NHIRD (from January 2004 to December 2014), and were treated with Pazopanib tablets 200 mg, were included in this study and their data was observed retrospectively.
Number of Participants With Changes in Prescription Patterns of Antihypertensive Medication From the Time of First Dose of Drug at Month 3 Unchanged	142 Participants	20 Participants
Number of Participants With Changes in Prescription Patterns of Antihypertensive Medication From the Time of First Dose of Drug at Month 3 Increased	176 Participants	21 Participants
Number of Participants With Changes in Prescription Patterns of Antihypertensive Medication From the Time of First Dose of Drug at Month 3 Decreased	57 Participants	13 Participants
Number of Participants With Changes in Prescription Patterns of Antihypertensive Medication From the Time of First Dose of Drug at Month 3 Switched	46 Participants	7 Participants

PRIMARY outcome

Timeframe: the first dose of the drug, Month 6

Population: All Taiwanese participants diagnosed with metastatic RCC during the time period of January 2004 to December 2015 and received treatment (Sunitinib or Pazopanib). Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure.

Changes in the prescription patterns of antihypertensive medication were categorized as: 1) Unchanged: no change in the count/number of capsules or class(es) of the antihypertensive medication at Month 6 as compared to the time of first dose, 2) Increased: increase in counts/number of capsules of the ongoing class(es) of the antihypertensive medication at Month 6 as compared to the time of first dose, 3) Decreased: Decrease in the counts/number of capsules of ongoing class(es) of antihypertensive medication at Month 6 as compared to the time of first dose, 4) Switched: shifted to other class(es) of antihypertensive medication without changes in counts of antihypertensive medication at Month 6 as compared to the time of first dose. The number of participants with change in prescription patterns based on the specified categories is reported.

Outcome measures

Measure	Sunitinib n=442 Participants Participants who were diagnosed with metastatic renal cell carcinoma (RCC), as per the records of Catastrophic illness patient database and National health insurance research database (NHIRD) (from January 2004 to December 2015), and were treated with Sunitinib capsule 12.5 milligram (mg), were included in this study and their data was observed retrospectively.	Pazopanib n=64 Participants Participants who were diagnosed with metastatic RCC, as per the records of Catastrophic illness patient database and NHIRD (from January 2004 to December 2014), and were treated with Pazopanib tablets 200 mg, were included in this study and their data was observed retrospectively.
Number of Participants With Changes in Prescription Patterns of Antihypertensive Medication From the Time of First Dose of Drug at Month 6 Unchanged	132 Participants	18 Participants
Number of Participants With Changes in Prescription Patterns of Antihypertensive Medication From the Time of First Dose of Drug at Month 6 Increased	213 Participants	24 Participants
Number of Participants With Changes in Prescription Patterns of Antihypertensive Medication From the Time of First Dose of Drug at Month 6 Decreased	54 Participants	11 Participants
Number of Participants With Changes in Prescription Patterns of Antihypertensive Medication From the Time of First Dose of Drug at Month 6 Switched	43 Participants	11 Participants

PRIMARY outcome

Timeframe: the first dose of the medication, Month 12

Population: All Taiwanese participants diagnosed with metastatic RCC during the time period of January 2004 to December 2015 and received treatment (Sunitinib or Pazopanib). Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure.

Changes in the prescription patterns of antihypertensive medication were categorized as: 1) Unchanged: no change in the count/number of capsules or class(es) of the antihypertensive medication at Month 12 as compared to the time of first dose, 2) Increased: increase in counts/number of capsules of the ongoing class(es) of the antihypertensive medication at Month 12 as compared to the time of first dose, 3) Decreased: Decrease in the counts/number of capsules of ongoing class(es) of antihypertensive medication at Month 12 as compared to the time of first dose, 4) Switched: shifted to other class(es) of antihypertensive medication without changes in counts of antihypertensive medication at Month 12 as compared to the time of first dose. The number of participants with change in prescription patterns based on the specified categories is reported.

Outcome measures

Measure	Sunitinib n=446 Participants Participants who were diagnosed with metastatic renal cell carcinoma (RCC), as per the records of Catastrophic illness patient database and National health insurance research database (NHIRD) (from January 2004 to December 2015), and were treated with Sunitinib capsule 12.5 milligram (mg), were included in this study and their data was observed retrospectively.	Pazopanib n=66 Participants Participants who were diagnosed with metastatic RCC, as per the records of Catastrophic illness patient database and NHIRD (from January 2004 to December 2014), and were treated with Pazopanib tablets 200 mg, were included in this study and their data was observed retrospectively.
Number of Participants With Changes in Prescription Patterns of Antihypertensive Medication From the Time of First Dose of Drug at Month 12 Unchanged	104 Participants	17 Participants
Number of Participants With Changes in Prescription Patterns of Antihypertensive Medication From the Time of First Dose of Drug at Month 12 Increased	262 Participants	28 Participants
Number of Participants With Changes in Prescription Patterns of Antihypertensive Medication From the Time of First Dose of Drug at Month 12 Decreased	47 Participants	10 Participants
Number of Participants With Changes in Prescription Patterns of Antihypertensive Medication From the Time of First Dose of Drug at Month 12 Switched	33 Participants	11 Participants

PRIMARY outcome

Timeframe: Baseline (at the beginning of 11 year observation period)

Population: All Taiwanese participants diagnosed with metastatic RCC during the time period of January 2004 to December 2015 and received treatment (Sunitinib or Pazopanib). Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure.

To calculate number of patient receiving antihypertensive prescriptions at baseline for each TKI users and classify the patterns of changes into unchanged, switched, increased and decreased. Shifting to other class(es) of antihypertensive agents without changes in counts of antihypertensive medication is defined as being switched.

Outcome measures

Measure	Sunitinib n=657 Participants Participants who were diagnosed with metastatic renal cell carcinoma (RCC), as per the records of Catastrophic illness patient database and National health insurance research database (NHIRD) (from January 2004 to December 2015), and were treated with Sunitinib capsule 12.5 milligram (mg), were included in this study and their data was observed retrospectively.	Pazopanib n=94 Participants Participants who were diagnosed with metastatic RCC, as per the records of Catastrophic illness patient database and NHIRD (from January 2004 to December 2014), and were treated with Pazopanib tablets 200 mg, were included in this study and their data was observed retrospectively.
Number of Participants Who Received Antihypertensive Medication at Baseline	518 Participants	77 Participants

PRIMARY outcome

Timeframe: Baseline (at the beginning of 11 year observation period) up to Month 1

Population: All Taiwanese participants diagnosed with metastatic RCC during the time period of January 2004 to December 2015 and received treatment (Sunitinib or Pazopanib). Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure.

To calculate number of patient receiving antihypertensive prescriptions at Month 1 for each TKI users and classify the patterns of changes into unchanged, switched, increased and decreased. Shifting to other class(es) of antihypertensive agents without changes in counts of antihypertensive medication is defined as being switched.

Outcome measures

Measure	Sunitinib n=657 Participants Participants who were diagnosed with metastatic renal cell carcinoma (RCC), as per the records of Catastrophic illness patient database and National health insurance research database (NHIRD) (from January 2004 to December 2015), and were treated with Sunitinib capsule 12.5 milligram (mg), were included in this study and their data was observed retrospectively.	Pazopanib n=94 Participants Participants who were diagnosed with metastatic RCC, as per the records of Catastrophic illness patient database and NHIRD (from January 2004 to December 2014), and were treated with Pazopanib tablets 200 mg, were included in this study and their data was observed retrospectively.
Number of Participants Who Received Antihypertensive Medication From Baseline to Month 1	66 Participants	5 Participants

PRIMARY outcome

Timeframe: Month 1 up to Month 3 since Sunitinib or Pazopanib initiation (during the observation period of 11 years)

Population: All Taiwanese participants diagnosed with metastatic RCC during the time period of January 2004 to December 2015 and received treatment (Sunitinib or Pazopanib). Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure.

To calculate number of patient receiving antihypertensive prescriptions from Month 1 to Month 3 for each TKI users and classify the patterns of changes into unchanged, switched, increased and decreased. Shifting to other class(es) of antihypertensive agents without changes in counts of antihypertensive medication is defined as being switched.

Outcome measures

Measure	Sunitinib n=657 Participants Participants who were diagnosed with metastatic renal cell carcinoma (RCC), as per the records of Catastrophic illness patient database and National health insurance research database (NHIRD) (from January 2004 to December 2015), and were treated with Sunitinib capsule 12.5 milligram (mg), were included in this study and their data was observed retrospectively.	Pazopanib n=94 Participants Participants who were diagnosed with metastatic RCC, as per the records of Catastrophic illness patient database and NHIRD (from January 2004 to December 2014), and were treated with Pazopanib tablets 200 mg, were included in this study and their data was observed retrospectively.
Number of Participants Who Received Antihypertensive Medication From Month 1 to Month 3	30 Participants	7 Participants

PRIMARY outcome

Timeframe: Month 3 up to Month 6 since Sunitinib or Pazopanib initiation (during the observation period of 11 years)

Population: All Taiwanese participants diagnosed with metastatic RCC during the time period of January 2004 to December 2015 and received treatment (Sunitinib or Pazopanib). Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure.

To calculate number of patient receiving antihypertensive prescriptions from Month 3 to Month 6 for each TKI users and classify the patterns of changes into unchanged, switched, increased and decreased. Shifting to other class(es) of antihypertensive agents without changes in counts of antihypertensive medication is defined as being switched.

Outcome measures

Measure	Sunitinib n=657 Participants Participants who were diagnosed with metastatic renal cell carcinoma (RCC), as per the records of Catastrophic illness patient database and National health insurance research database (NHIRD) (from January 2004 to December 2015), and were treated with Sunitinib capsule 12.5 milligram (mg), were included in this study and their data was observed retrospectively.	Pazopanib n=94 Participants Participants who were diagnosed with metastatic RCC, as per the records of Catastrophic illness patient database and NHIRD (from January 2004 to December 2014), and were treated with Pazopanib tablets 200 mg, were included in this study and their data was observed retrospectively.
Number of Participants Who Received Antihypertensive Medication From Month 3 to Month 6	15 Participants	5 Participants

PRIMARY outcome

Timeframe: Month 6 up to Month 12 since Sunitinib or Pazopanib initiation (during the observation period of 11 years)

Population: All Taiwanese participants diagnosed with metastatic RCC during the time period of January 2004 to December 2015 and received treatment (Sunitinib or Pazopanib). Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure.

To calculate number of patient receiving antihypertensive prescriptions from Month 6 to Month 12 for each TKI users and classify the patterns of changes into unchanged, switched, increased and decreased. Shifting to other class(es) of antihypertensive agents without changes in counts of antihypertensive medication is defined as being switched.

Outcome measures

Measure	Sunitinib n=657 Participants Participants who were diagnosed with metastatic renal cell carcinoma (RCC), as per the records of Catastrophic illness patient database and National health insurance research database (NHIRD) (from January 2004 to December 2015), and were treated with Sunitinib capsule 12.5 milligram (mg), were included in this study and their data was observed retrospectively.	Pazopanib n=94 Participants Participants who were diagnosed with metastatic RCC, as per the records of Catastrophic illness patient database and NHIRD (from January 2004 to December 2014), and were treated with Pazopanib tablets 200 mg, were included in this study and their data was observed retrospectively.
Number of Participants Who Received Antihypertensive Medication From Month 6 to Month 12	18 Participants	NA Participants Due to NHIRD regulation, data cannot be reported if sample size \<=3.

Adverse Events

Sunitinib

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pazopanib

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

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