Renal Cell Carcinoma
Conditions
Keywords
renal cell carcinoma, sunitinib, pazopanib, temsirolimus, sorafenib, everolimus, interferon alpha, interleukin 2
Brief summary
The clinical outcome of advanced / metastatic renal cell carcinoma has been changed since targeted therapy being widely applied. This study will retrospectively analyse the clinical outcome of advanced renal cell carcinoma captured in Taiwan National Health Insurance Research Database.
Detailed description
Targeted therapy agents have significantly changed the clinical outcome of advanced / metastatic renal cell carcinoma. However, the dosing pattern varied and might result in impact to duration of treatment. In Taiwan, National Health Insurance system has a coverage more than 90% of population and thus can serve as an appropriate database for further analysis on Taiwanese advanced renal cell carcinoma. This study will retrospectively analyse the clinical outcome of advanced renal cell carcinoma captured in Taiwan National Health Insurance Research Database.
Interventions
None listed
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* advanced/metastatic renal cell carcinoma
Exclusion criteria
* N/A
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Sunitinib and Pazopanib Treatment in Participants | during the observation period of 11 years | 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. |
| Cumulative Number of Capsules of Sunitinib and Pazopanib Administered From the Time of Start of Treatment Up to Month 3 | from the time of start of treatment up to Month 3 | 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. |
| Cumulative Number of Capsules of Sunitinib and Pazopanib Administered From Month 3 to Month 6 | Month 3 up to Month 6 | 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. |
| Cumulative Number of Capsules of Sunitinib and Pazopanib Administered From Month 6 to Month 9 | Month 6 up to Month 9 | 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. |
| Cumulative Number of Capsules of Sunitinib and Pazopanib Administered From Month 9 to Month 12 | Month 9 up to Month 12 | 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. |
| Cumulative Number of Capsules of Sunitinib and Pazopanib Administered From the Time of Start of Treatment Up to Month 12 | from the time of start of treatment up to Month 12 | 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. |
| Overall Renal Cell Carcinoma (RCC) Related Direct Medical Cost From the Diagnosis Date to the First Dose of Sunitinib and Pazopanib | from the time of disease diagnosis till the first dose of Sunitinib and Pazopanib | 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. |
| Overall Renal Cell Carcinoma (RCC) Related Direct Medical Cost From the First Dose of the Sunitinib and Pazopanib to the End of Observation Period | From first dose of drug to the end of observation period (up to 11 years) | 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. |
| Overall Survival | from the time of first prescription of Sunitinib or Pazopanib till date of death (during the observation period of 11 years) | Overall survival of participants was defined as time (in days) between date of prescribing treatment (Sunitinib or Pazopanib) till date of death. |
| Number of Participants With Changes in Prescription Patterns of Antihypertensive Medication From the Time of First Dose of Drug at Month 1 | time of first dose of the drug, Month 1 | 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. |
| Number of Participants With Changes in Prescription Patterns of Antihypertensive Medication From the Time of First Dose of Drug at Month 3 | time of first dose of the drug, Month 3 | 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. |
| Number of Participants With Changes in Prescription Patterns of Antihypertensive Medication From the Time of First Dose of Drug at Month 6 | the first dose of the drug, Month 6 | 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. |
| Number of Participants With Changes in Prescription Patterns of Antihypertensive Medication From the Time of First Dose of Drug at Month 12 | the first dose of the medication, Month 12 | 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. |
| Number of Participants Who Received Antihypertensive Medication at Baseline | Baseline (at the beginning of 11 year observation period) | 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. |
| Number of Participants Who Received Antihypertensive Medication From Baseline to Month 1 | Baseline (at the beginning of 11 year observation period) up to Month 1 | 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. |
| Number of Participants Who Received Antihypertensive Medication From Month 1 to Month 3 | Month 1 up to Month 3 since Sunitinib or Pazopanib initiation (during the observation period of 11 years) | 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. |
| Number of Participants Who Received Antihypertensive Medication From Month 3 to Month 6 | Month 3 up to Month 6 since Sunitinib or Pazopanib initiation (during the observation period of 11 years) | 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. |
| Number of Participants Who Received Antihypertensive Medication From Month 6 to Month 12 | Month 6 up to Month 12 since Sunitinib or Pazopanib initiation (during the observation period of 11 years) | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 1,223 |
| 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. | 126 |
| Total | 1,349 |
Baseline characteristics
| Characteristic | Total | Pazopanib | Sunitinib |
|---|---|---|---|
| Age, Continuous | 64.33 years STANDARD_DEVIATION 12.99 | 66.45 years STANDARD_DEVIATION 12.95 | 64.14 years STANDARD_DEVIATION 13 |
| Participants Admitted/Visited to Hospital by Type of Hospitals Medical center | 956 Participants | 91 Participants | 865 Participants |
| Participants Admitted/Visited to Hospital by Type of Hospitals Other than medical center | 393 Participants | 35 Participants | 358 Participants |
| Participants Admitted/Visited to the Hospital According to the Geographical Location of Hospitals Capital area hospital | 487 Participants | 40 Participants | 447 Participants |
| Participants Admitted/Visited to the Hospital According to the Geographical Location of Hospitals Non-capital area hospital | 862 Participants | 86 Participants | 776 Participants |
| Participants by Different Income Levels High income | 658 Participants | 65 Participants | 593 Participants |
| Participants by Different Income Levels Low income | 303 Participants | 24 Participants | 279 Participants |
| Participants by Different Income Levels Medium income | 388 Participants | 37 Participants | 351 Participants |
| Participants Who Had Received Concomitant-Medications Angiotensin-converting enzyme inhibitors | 146 Participants | 11 Participants | 135 Participants |
| Participants Who Had Received Concomitant-Medications Angiotensin receptor blocker | 437 Participants | 40 Participants | 397 Participants |
| Participants Who Had Received Concomitant-Medications Anticoagulants | NA Participants | NA Participants | 32 Participants |
| Participants Who Had Received Concomitant-Medications Antiplatelets | 386 Participants | 34 Participants | 352 Participants |
| Participants Who Had Received Concomitant-Medications Beta blockers | 402 Participants | 38 Participants | 364 Participants |
| Participants Who Had Received Concomitant-Medications Biguanides | 211 Participants | 22 Participants | 189 Participants |
| Participants Who Had Received Concomitant-Medications Bile acid sequestrants and Nicotinic acid | NA Participants | NA Participants | 4 Participants |
| Participants Who Had Received Concomitant-Medications Calcium channel blockers | 600 Participants | 57 Participants | 543 Participants |
| Participants Who Had Received Concomitant-Medications Dipeptidyl peptidase 4 inhibitors | 99 Participants | 19 Participants | 80 Participants |
| Participants Who Had Received Concomitant-Medications Diuretics | 369 Participants | 38 Participants | 331 Participants |
| Participants Who Had Received Concomitant-Medications Ezetimibe | NA Participants | NA Participants | 18 Participants |
| Participants Who Had Received Concomitant-Medications Fibrates | 62 Participants | 6 Participants | 56 Participants |
| Participants Who Had Received Concomitant-Medications Glucosidase inhibitors | 60 Participants | 4 Participants | 56 Participants |
| Participants Who Had Received Concomitant-Medications Insulin | 60 Participants | 7 Participants | 53 Participants |
| Participants Who Had Received Concomitant-Medications Statins | 269 Participants | 27 Participants | 242 Participants |
| Participants Who Had Received Concomitant-Medications Sulfonylurea | 202 Participants | 16 Participants | 186 Participants |
| Participants Who Had Received Concomitant-Medications Thiazolidinediones | NA Participants | NA Participants | 46 Participants |
| Participants With Different Co-Morbid Conditions Chronic kidney disease | 176 Participants | 17 Participants | 159 Participants |
| Participants With Different Co-Morbid Conditions Coronary artery disease | 218 Participants | 30 Participants | 188 Participants |
| Participants With Different Co-Morbid Conditions Diabetes mellitus | 389 Participants | 39 Participants | 350 Participants |
| Participants With Different Co-Morbid Conditions Dyslipidemia | 344 Participants | 32 Participants | 312 Participants |
| Participants With Different Co-Morbid Conditions Hypertension | 693 Participants | 59 Participants | 634 Participants |
| Participants With Different Co-Morbid Conditions Liver cirrhosis | NA Participants | NA Participants | 26 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Sex/Gender, Customized Female | 355 Participants | 37 Participants | 318 Participants |
| Sex/Gender, Customized Male | 992 Participants | 89 Participants | 903 Participants |
| Sex/Gender, Customized Unknown | 2 Participants | 0 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Cumulative Number of Capsules of Sunitinib and Pazopanib Administered From Month 3 to Month 6
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.
Time frame: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sunitinib | Cumulative Number of Capsules of Sunitinib and Pazopanib Administered From Month 3 to Month 6 | 165.0 capsules | Standard Deviation 88.4 |
| Pazopanib | Cumulative Number of Capsules of Sunitinib and Pazopanib Administered From Month 3 to Month 6 | 193.2 capsules | Standard Deviation 118.9 |
Primary
Cumulative Number of Capsules of Sunitinib and Pazopanib Administered From Month 6 to Month 9
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.
Time frame: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sunitinib | Cumulative Number of Capsules of Sunitinib and Pazopanib Administered From Month 6 to Month 9 | 174.9 capsules | Standard Deviation 83.5 |
| Pazopanib | Cumulative Number of Capsules of Sunitinib and Pazopanib Administered From Month 6 to Month 9 | 186.5 capsules | Standard Deviation 111.1 |
Primary
Cumulative Number of Capsules of Sunitinib and Pazopanib Administered From Month 9 to Month 12
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.
Time frame: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sunitinib | Cumulative Number of Capsules of Sunitinib and Pazopanib Administered From Month 9 to Month 12 | 176.5 capsules | Standard Deviation 83.4 |
| Pazopanib | Cumulative Number of Capsules of Sunitinib and Pazopanib Administered From Month 9 to Month 12 | 212.1 capsules | Standard Deviation 109.9 |
Primary
Cumulative Number of Capsules of Sunitinib and Pazopanib Administered From the Time of Start of Treatment Up to Month 12
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.
Time frame: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sunitinib | 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 |
| Pazopanib | Cumulative Number of Capsules of Sunitinib and Pazopanib Administered From the Time of Start of Treatment Up to Month 12 | 438.0 capsules | Standard Deviation 375.1 |
Primary
Cumulative Number of Capsules of Sunitinib and Pazopanib Administered From the Time of Start of Treatment Up to Month 3
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.
Time frame: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sunitinib | 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 |
| Pazopanib | Cumulative Number of Capsules of Sunitinib and Pazopanib Administered From the Time of Start of Treatment Up to Month 3 | 215.1 capsules | Standard Deviation 118.4 |
Primary
Duration of Sunitinib and Pazopanib Treatment in Participants
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.
Time frame: 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).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sunitinib | Duration of Sunitinib and Pazopanib Treatment in Participants | 171 days |
| Pazopanib | Duration of Sunitinib and Pazopanib Treatment in Participants | 114.5 days |
Primary
Number of Participants Who Received Antihypertensive Medication at Baseline
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sunitinib | Number of Participants Who Received Antihypertensive Medication at Baseline | 518 Participants |
| Pazopanib | Number of Participants Who Received Antihypertensive Medication at Baseline | 77 Participants |
Primary
Number of Participants Who Received Antihypertensive Medication From Baseline to Month 1
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sunitinib | Number of Participants Who Received Antihypertensive Medication From Baseline to Month 1 | 66 Participants |
| Pazopanib | Number of Participants Who Received Antihypertensive Medication From Baseline to Month 1 | 5 Participants |
Primary
Number of Participants Who Received Antihypertensive Medication From Month 1 to Month 3
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sunitinib | Number of Participants Who Received Antihypertensive Medication From Month 1 to Month 3 | 30 Participants |
| Pazopanib | Number of Participants Who Received Antihypertensive Medication From Month 1 to Month 3 | 7 Participants |
Primary
Number of Participants Who Received Antihypertensive Medication From Month 3 to Month 6
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sunitinib | Number of Participants Who Received Antihypertensive Medication From Month 3 to Month 6 | 15 Participants |
| Pazopanib | Number of Participants Who Received Antihypertensive Medication From Month 3 to Month 6 | 5 Participants |
Primary
Number of Participants Who Received Antihypertensive Medication From Month 6 to Month 12
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sunitinib | Number of Participants Who Received Antihypertensive Medication From Month 6 to Month 12 | 18 Participants |
| Pazopanib | Number of Participants Who Received Antihypertensive Medication From Month 6 to Month 12 | NA Participants |
Primary
Number of Participants With Changes in Prescription Patterns of Antihypertensive Medication From the Time of First Dose of Drug at Month 1
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sunitinib | 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 |
| Sunitinib | 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 |
| Sunitinib | 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 |
| Sunitinib | 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 |
| Pazopanib | Number of Participants With Changes in Prescription Patterns of Antihypertensive Medication From the Time of First Dose of Drug at Month 1 | Switched | 6 Participants |
| Pazopanib | Number of Participants With Changes in Prescription Patterns of Antihypertensive Medication From the Time of First Dose of Drug at Month 1 | Unchanged | 9 Participants |
| Pazopanib | Number of Participants With Changes in Prescription Patterns of Antihypertensive Medication From the Time of First Dose of Drug at Month 1 | Decreased | 14 Participants |
| Pazopanib | Number of Participants With Changes in Prescription Patterns of Antihypertensive Medication From the Time of First Dose of Drug at Month 1 | Increased | 14 Participants |
Primary
Number of Participants With Changes in Prescription Patterns of Antihypertensive Medication From the Time of First Dose of Drug at Month 12
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sunitinib | 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 |
| Sunitinib | 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 |
| Sunitinib | 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 |
| Sunitinib | 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 |
| Pazopanib | Number of Participants With Changes in Prescription Patterns of Antihypertensive Medication From the Time of First Dose of Drug at Month 12 | Switched | 11 Participants |
| Pazopanib | Number of Participants With Changes in Prescription Patterns of Antihypertensive Medication From the Time of First Dose of Drug at Month 12 | Unchanged | 17 Participants |
| Pazopanib | Number of Participants With Changes in Prescription Patterns of Antihypertensive Medication From the Time of First Dose of Drug at Month 12 | Decreased | 10 Participants |
| Pazopanib | Number of Participants With Changes in Prescription Patterns of Antihypertensive Medication From the Time of First Dose of Drug at Month 12 | Increased | 28 Participants |
Primary
Number of Participants With Changes in Prescription Patterns of Antihypertensive Medication From the Time of First Dose of Drug at Month 3
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sunitinib | 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 |
| Sunitinib | 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 |
| Sunitinib | 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 |
| Sunitinib | 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 |
| Pazopanib | Number of Participants With Changes in Prescription Patterns of Antihypertensive Medication From the Time of First Dose of Drug at Month 3 | Switched | 7 Participants |
| Pazopanib | Number of Participants With Changes in Prescription Patterns of Antihypertensive Medication From the Time of First Dose of Drug at Month 3 | Unchanged | 20 Participants |
| Pazopanib | Number of Participants With Changes in Prescription Patterns of Antihypertensive Medication From the Time of First Dose of Drug at Month 3 | Decreased | 13 Participants |
| Pazopanib | Number of Participants With Changes in Prescription Patterns of Antihypertensive Medication From the Time of First Dose of Drug at Month 3 | Increased | 21 Participants |
Primary
Number of Participants With Changes in Prescription Patterns of Antihypertensive Medication From the Time of First Dose of Drug at Month 6
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sunitinib | 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 |
| Sunitinib | 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 |
| Sunitinib | 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 |
| Sunitinib | 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 |
| Pazopanib | Number of Participants With Changes in Prescription Patterns of Antihypertensive Medication From the Time of First Dose of Drug at Month 6 | Switched | 11 Participants |
| Pazopanib | Number of Participants With Changes in Prescription Patterns of Antihypertensive Medication From the Time of First Dose of Drug at Month 6 | Unchanged | 18 Participants |
| Pazopanib | Number of Participants With Changes in Prescription Patterns of Antihypertensive Medication From the Time of First Dose of Drug at Month 6 | Decreased | 11 Participants |
| Pazopanib | Number of Participants With Changes in Prescription Patterns of Antihypertensive Medication From the Time of First Dose of Drug at Month 6 | Increased | 24 Participants |
Primary
Overall Renal Cell Carcinoma (RCC) Related Direct Medical Cost From the Diagnosis Date to the First Dose of Sunitinib and Pazopanib
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sunitinib | 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 |
| Pazopanib | Overall Renal Cell Carcinoma (RCC) Related Direct Medical Cost From the Diagnosis Date to the First Dose of Sunitinib and Pazopanib | 45,442,288 new Taiwan dollars |
Primary
Overall Renal Cell Carcinoma (RCC) Related Direct Medical Cost From the First Dose of the Sunitinib and Pazopanib to the End of Observation Period
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sunitinib | 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 |
| Pazopanib | Overall Renal Cell Carcinoma (RCC) Related Direct Medical Cost From the First Dose of the Sunitinib and Pazopanib to the End of Observation Period | 78,745,896 new Taiwan dollars |
Primary
Overall Survival
Overall survival of participants was defined as time (in days) between date of prescribing treatment (Sunitinib or Pazopanib) till date of death.
Time frame: 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).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sunitinib | Overall Survival | 490 days |
| Pazopanib | Overall Survival | 416 days |