Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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. | during the observation period of 11 years |
| 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. | from the time of start of treatment up to Month 3 |
| 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. | Month 3 up to Month 6 |
| 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. | Month 6 up to Month 9 |
| 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. | Month 9 up to Month 12 |
| Cumulative Number of Capsules of Sunitinib and Pazopanib Administered From the Time of Start of Treatment Up to Month 12 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
advanced/metastatic renal cell carcnioma
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
Not provided
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All Taiwanese participants diagnosed with metastatic RCC during the time period of January 2004 to December 2015 and received treatment (Sunitinib or Pazopanib).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All Taiwanese participants diagnosed with metastatic RCC during the time period of January 2004 to December 2015 and received treatment (Sunitinib or Pazopanib). | Posted | Median | Full Range | days | during the observation period of 11 years |
|
Not provided
Due to the non-interventional nature of this study, adverse events (AEs) were not collected for this study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Prioritization of outcome measures as primary and secondary was based on the study team's discretion.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 31, 2016 | Dec 24, 2018 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
Not provided
Not provided
Not provided
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. |
| from the time of start of treatment up to Month 12 |
| 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. | from the time of disease diagnosis till the first dose of Sunitinib and 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 | 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. | From first dose of drug to the end of observation period (up to 11 years) |
| Overall Survival | Overall survival of participants was defined as time (in days) between date of prescribing treatment (Sunitinib or Pazopanib) till date of death. | from the time of first prescription of Sunitinib or Pazopanib till date of death (during the observation period of 11 years) |
| 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 of first dose of the drug, Month 1 |
| 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 of first dose of the drug, Month 3 |
| 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. | the first dose of the drug, Month 6 |
| 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. | the first dose of the medication, Month 12 |
| 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. | Baseline (at the beginning of 11 year observation period) |
| 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. | Baseline (at the beginning of 11 year observation period) up to Month 1 |
| 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. | Month 1 up to Month 3 since Sunitinib or Pazopanib initiation (during the observation period of 11 years) |
| 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. | Month 3 up to Month 6 since Sunitinib or Pazopanib initiation (during the observation period of 11 years) |
| 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. | Month 6 up to Month 12 since Sunitinib or Pazopanib initiation (during the observation period of 11 years) |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Participants by Different Income Levels | Income levels of the participants were divided into three categories, 1) Low income, which included all the participants with income less the 15,000 new Taiwan dollars per month, 2) Median income, which included all the participants with income 15,000-24,999 new Taiwan dollars per month, 3) High income, which included all the participants with income more than 25,000 new Taiwan dollars per month. | Count of Participants | Participants |
|
| Participants With Different Co-Morbid Conditions | Co-morbid conditions included all diseases (hypertension, diabetes mellitus, dyslipidemia, coronary artery disease, chronic kidney disease, and liver cirrhosis) other than metastatic RCC, from which the participants were suffering during the observation period. A participant could have more than one co-morbid condition. Here, NHIRD in the comment field signifies to National Health Insurance Research Database. | Count of Participants | Participants |
|
| Participants Who Had Received Concomitant-Medications | Concomitant-medications were the medications that the study participants had taken along with Sunitinib or Pazopanib. Participants could have received more than one concomitant medication. | Count of Participants | Participants |
|
| Participants Admitted/Visited to Hospital by Type of Hospitals | Medical center was defined by Taiwan Food and Drug Administration as hospitals accredited with medical training, research, high-tech equipment, and ability to support other hospital nearby. | Count of Participants | Participants |
|
| Participants Admitted/Visited to the Hospital According to the Geographical Location of Hospitals | Geographical location of hospitals included capital area and non-capital area. Capital area hospitals includes the hospitals that were located at national capital and non-capital area hospitals includes the hospitals that were located outside of national capital. | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
| 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. | All Taiwanese participants diagnosed with metastatic RCC during the time period of January 2004 to December 2015 and received treatment (Sunitinib or Pazopanib). | Posted | Mean | Standard Deviation | capsules | from the time of start of treatment up to Month 3 |
|
|
|
| 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. | All Taiwanese participants diagnosed with metastatic RCC during the time period of January 2004 to December 2015 and received treatment (Sunitinib or Pazopanib). | Posted | Mean | Standard Deviation | capsules | Month 3 up to Month 6 |
|
|
|
| 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. | All Taiwanese participants diagnosed with metastatic RCC during the time period of January 2004 to December 2015 and received treatment (Sunitinib or Pazopanib). | Posted | Mean | Standard Deviation | capsules | Month 6 up to Month 9 |
|
|
|
| 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. | All Taiwanese participants diagnosed with metastatic RCC during the time period of January 2004 to December 2015 and received treatment (Sunitinib or Pazopanib). | Posted | Mean | Standard Deviation | capsules | Month 9 up to Month 12 |
|
|
|
| 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. | All Taiwanese participants diagnosed with metastatic RCC during the time period of January 2004 to December 2015 and received treatment (Sunitinib or Pazopanib). | Posted | Mean | Standard Deviation | capsules | from the time of start of treatment up to Month 12 |
|
|
|
| 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. | 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. | Posted | Number | new Taiwan dollars | from the time of disease diagnosis till the first dose of Sunitinib and Pazopanib |
|
|
|
| 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. | 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. | Posted | Number | new Taiwan dollars | From first dose of drug to the end of observation period (up to 11 years) |
|
|
|
| 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. | All Taiwanese participants diagnosed with metastatic RCC during the time period of January 2004 to December 2015 and received treatment (Sunitinib or Pazopanib). | Posted | Median | 95% Confidence Interval | days | from the time of first prescription of Sunitinib or Pazopanib till date of death (during the observation period of 11 years) |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | time of first dose of the drug, Month 1 |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | time of first dose of the drug, Month 3 |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | the first dose of the drug, Month 6 |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | the first dose of the medication, Month 12 |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Baseline (at the beginning of 11 year observation period) |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Baseline (at the beginning of 11 year observation period) up to Month 1 |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Month 1 up to Month 3 since Sunitinib or Pazopanib initiation (during the observation period of 11 years) |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Month 3 up to Month 6 since Sunitinib or Pazopanib initiation (during the observation period of 11 years) |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Month 6 up to Month 12 since Sunitinib or Pazopanib initiation (during the observation period of 11 years) |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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.
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| Unknown |
|
| Decreased |
|
| Switched |
|
| Decreased |
|
| Switched |
|
| Decreased |
|
| Switched |
|
| Decreased |
|
| Switched |
|