| Primary | Progression Free Survival (PFS) | PFS was defined as the time duration (in months) during and after the treatment of disease that a participant lived with the disease but it did not get worse or progressed. Progressive disease as per response evaluation criteria in solid tumors (RECIST) version 1.1 defined as at least a 20 percent (%) increase in the sum of longest dimensions of target lesions, reference to the smallest sum of the longest dimensions recorded since the treatment started, or the appearance of one or more new lesions or increase of at least 5 millimeter (mm) in addition to the relative increase of 20%. | Analysis was performed on all enrolled participants. | Posted | | Median | 95% Confidence Interval | months | | From the start of disease treatment until disease progression or death due to any cause (up to a maximum of 33 months) | | | | ID | Title | Description |
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| OG000 | Metastatic Renal Cell Carcinoma (mRCC) Cohort | Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000NA(NA to NA)Data was not estimable due to less number of participants with events.
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| Primary | Percentage of Participants With Overall Objective Response | Overall objective response was defined as the percentage of participants with best confirmed response (partial response [PR], stable disease [SD] or progressive disease [PD]) recorded from the start of the study treatment until the end of treatment as assessed by RECIST version 1.1. PR defined as a 30% or more decrease in the sum of longest dimensions of the target lesions, taking as reference the baseline sum of longest dimensions. PD defined as at least a 20% increase in the sum of longest dimensions of target lesions, reference to the smallest sum of the longest dimensions recorded since the treatment started, or the appearance of one or more new lesions or increase of at least 5 mm in addition to the relative increase of 20%. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference to the smallest sum diameters while on study. | Analysis was performed on all enrolled participants. | Posted | | Number | | percentage of participants | | Baseline until the maximum of 33 months | | | | ID | Title | Description |
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| OG000 | Metastatic Renal Cell Carcinoma (mRCC) Cohort | Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months. |
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| Primary | Functional Assessment of Cancer Therapy Kidney Symptom Index - 15 (FKSI-15) Score at Baseline | FKSI was used to assess quality of life (QoL) of the participants and consisted of 15 items (lack of energy, side effects, pain, losing weight, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria and sleep). Each of the 15 items was answered on a 5-point Likert scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score = sum of the 15 item scores; total range: 0 - 60; 0 (no symptoms) to 60 (very much); higher score indicated greater presence of symptoms/worse quality of life. | Analysis was performed on all enrolled participants. Here, "overall number of participants analysed", indicates participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Day 1 of Month 1) | | | | ID | Title | Description |
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| OG000 | Metastatic Renal Cell Carcinoma (mRCC) Cohort | Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months. |
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| Primary | Change From Baseline in FKSI-15 Score at Month 3 | FKSI was used to assess QoL of the participants and consisted of 15 items (lack of energy, side effects, pain, losing weight, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria and sleep). Each of the 15 items was answered on a 5-point Likert scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score = sum of the 15 item scores; total range: 0 - 60; 0 (no symptoms) to 60 (very much); higher score indicated greater presence of symptoms/worse quality of life. | Analysis was performed on all enrolled participants. Here, "overall number of participants analysed", indicates participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Day 1 of Month 1), Month 3 | | | | ID | Title | Description |
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| OG000 | Metastatic Renal Cell Carcinoma (mRCC) Cohort | Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months. |
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| Primary | Change From Baseline in FKSI-15 Score at Month 6 | FKSI was used to assess quality of life (QoL) of the participants and consisted of 15 items (lack of energy, side effects, pain, losing weight, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria and sleep). Each of the 15 items was answered on a 5-point Likert scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score = sum of the 15 item scores; total range: 0 - 60; 0 (no symptoms) to 60 (very much); higher score indicated greater presence of symptoms/worse quality of life. | Analysis was performed on all enrolled participants. Here, "overall number of participants analysed", indicates participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Day 1 of Month 1), Month 6 | | | | ID | Title | Description |
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| OG000 | Metastatic Renal Cell Carcinoma (mRCC) Cohort | Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months. |
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| Primary | Change From Baseline in FKSI-15 Score at Month 9 | FKSI was used to assess quality of life (QoL) of the participants and consisted of 15 items (lack of energy, side effects, pain, losing weight, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria and sleep). Each of the 15 items was answered on a 5-point Likert scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score = sum of the 15 item scores; total range: 0 - 60; 0 (no symptoms) to 60 (very much); higher score indicated greater presence of symptoms/worse quality of life. | Analysis was performed on all enrolled participants. Here, "overall number of participants analysed", indicates participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Day 1 of Month 1), Month 9 | | | | ID | Title | Description |
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| OG000 | Metastatic Renal Cell Carcinoma (mRCC) Cohort | Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months. |
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| Primary | Change From Baseline in FKSI-15 Score at Last Follow-up | FKSI was used to assess quality of life (QoL) of the participants and consisted of 15 items (lack of energy, side effects, pain, losing weight, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria and sleep). Each of the 15 items was answered on a 5-point Likert scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score = sum of the 15 item scores; total range: 0 - 60; 0 (no symptoms) to 60 (very much); higher score indicated greater presence of symptoms/worse quality of life. | Analysis was performed on all enrolled participants. Here, "overall number of participants analysed", indicates participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Day 1 of Month 1), last follow-up visit (up to 33 months) | | | | ID | Title | Description |
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| OG000 | Metastatic Renal Cell Carcinoma (mRCC) Cohort | Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months. |
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| Primary | EuroQol-5 Dimension-3 Level (EQ5D-3L) Scores at Baseline | EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions. Participants rated 5 aspects of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The mean of the summed score ranged from 1 to 3 with "1" corresponding to no problems and "3" corresponding to severe problems in the 5 dimensions, where higher score indicates more severe problems. Total index EQ-5D-3L summary score is weighted with a range of -0.594 (worst) to 1.0 (best). | Analysis was performed on all enrolled participants. Here, "overall number of participants analysed", indicates participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Day 1 of Month 1) | | | | ID | Title | Description |
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| OG000 | Metastatic Renal Cell Carcinoma (mRCC) Cohort | Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months. |
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| Primary | Change From Baseline in EQ5D-3L Scores at Month 3 | EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions. Participants rated 5 aspects of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The summed score ranged from 1-15 with "1" corresponding to no problems and "15" corresponding to severe problems in the 5 dimensions, where higher score indicates more severe problems. | Analysis was performed on all enrolled participants. Here, "overall number of participants analysed", indicates participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Day 1 of Month 1), Month 3 | | | | ID | Title | Description |
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| OG000 | Metastatic Renal Cell Carcinoma (mRCC) Cohort | Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months. |
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| Primary | Change From Baseline in EQ5D-3L Score at Month 6 | EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions. Participants rated 5 aspects of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The summed score ranged from 1-15 with "1" corresponding to no problems and "15" corresponding to severe problems in the 5 dimensions, where higher score indicates more severe problems. | Analysis was performed on all enrolled participants. Here, "overall number of participants analysed", indicates participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Day 1 of Month 1), Month 6 | | | | ID | Title | Description |
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| OG000 | Metastatic Renal Cell Carcinoma (mRCC) Cohort | Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months. |
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| Primary | Change From Baseline in EQ5D-3L Score at Month 9 | EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions. Participants rated 5 aspects of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The summed score ranged from 1-15 with "1" corresponding to no problems and "15" corresponding to severe problems in the 5 dimensions, where higher score indicates more severe problems. | Analysis was performed on all enrolled participants. Here, "overall number of participants analysed", indicates participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Day 1 of Month 1), Month 9 | | | | ID | Title | Description |
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| OG000 | Metastatic Renal Cell Carcinoma (mRCC) Cohort | Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months. |
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| Primary | Change From Baseline in EQ5D-3L Score at Last Follow-up | EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions. Participants rated 5 aspects of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The summed score ranged from 1-15 with "1" corresponding to no problems and "15" corresponding to severe problems in the 5 dimensions, where higher score indicates more severe problems. | Analysis was performed on all enrolled participants. Here, "overall number of participants analysed", indicates participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Day 1 of Month 1), last follow up visit (up to 33 months) | | | | ID | Title | Description |
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| OG000 | Metastatic Renal Cell Carcinoma (mRCC) Cohort | Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months. |
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| Primary | Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease-Related Symptoms (FKSI-DRS) Score at Baseline | FKSI-DRS was used to assess quality of life in participants and consisted of 9 items (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, and hematuria). Each of the 9 items was answered on a 5-point Likert scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI-DRS score = sum of the 9 item scores; total range: 0 - 36; 0 (no symptom) to 36 (very much); higher score indicated greater presence of symptom. | Analysis was performed on all enrolled participants. Here, "overall number of participants analysed", indicates participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Day 1 of Month 1) | | | | ID | Title | Description |
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| OG000 | Metastatic Renal Cell Carcinoma (mRCC) Cohort | Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months. |
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| Primary | Change From Baseline in FKSI-DRS Score at Month 3 | FKSI-DRS was used to assess quality of life in participants and consisted of 9 items (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, and hematuria). Each of the 9 items was answered on a 5-point Likert scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI-DRS score = sum of the 9 item scores; total range: 0 - 36; 0 (no symptom) to 36 (very much); higher score indicated greater presence of symptom. | Analysis was performed on all enrolled participants. Here, "overall number of participants analysed", indicates participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Day 1 of Month 1), Month 3 | | | | ID | Title | Description |
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| OG000 | Metastatic Renal Cell Carcinoma (mRCC) Cohort | Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months. |
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| Primary | Change From Baseline in FKSI-DRS Score at Month 6 | FKSI-DRS was used to assess quality of life in participants and consisted of 9 items (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, and hematuria). Each of the 9 items was answered on a 5-point Likert scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI-DRS score = sum of the 9 item scores; total range: 0 - 36; 0 (no symptom) to 36 (very much); higher score indicated greater presence of symptom. | Analysis was performed on all enrolled participants. Here, "overall number of participants analysed", indicates participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Day 1 of Month 1), Month 6 | | | | ID | Title | Description |
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| OG000 | Metastatic Renal Cell Carcinoma (mRCC) Cohort | Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months. |
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| Primary | Change From Baseline in FKSI-DRS Score at Month 9 | FKSI-DRS was used to assess quality of life in participants and consisted of 9 items (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, and hematuria). Each of the 9 items was answered on a 5-point Likert scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI-DRS score = sum of the 9 item scores; total range: 0 - 36; 0 (no symptom) to 36 (very much); higher score indicated greater presence of symptom. | Analysis was performed on all enrolled participants. Here, "overall number of participants analysed", indicates participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Day 1 of Month 1), Month 9 | | | | ID | Title | Description |
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| OG000 | Metastatic Renal Cell Carcinoma (mRCC) Cohort | Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months. |
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| Primary | Change From Baseline in FKSI-DRS Score at Last Follow-up | FKSI-DRS was used to assess quality of life in participants and consisted of 9 items (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, and hematuria). Each of the 9 items was answered on a 5-point Likert scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI-DRS score = sum of the 9 item scores; total range: 0 - 36; 0 (no symptom) to 36 (very much); higher score indicated greater presence of symptom. | Analysis was performed on all enrolled participants. Here, "overall number of participants analysed", indicates participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Day 1 of Month 1), last follow up visit (up to 33 months) | | | | ID | Title | Description |
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| OG000 | Metastatic Renal Cell Carcinoma (mRCC) Cohort | Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months. |
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| Secondary | Overall Survival | Overall survival was defined as the time from the start of 3rd line treatment until date of death due to any cause. | Analysis was performed on all enrolled participants. | Posted | | Median | Full Range | months | | From the start of 3rd line treatment until death due to any cause (up to a maximum of 33 months) | | | | ID | Title | Description |
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| OG000 | Metastatic Renal Cell Carcinoma (mRCC) Cohort | Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months. |
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| Secondary | Overall Survival at Year 1: Percentage of Participants Who Survived at Year 1 | Overall survival at Year 1 (Month 12) was defined as the time from the start of 3rd line treatment until death or 1 year due to any cause (measured at the end of 12 month follow-up/observation period). Percentage of participants who survived at the completion of 1 year (12 months) period were reported in this outcome measure. | Analysis was performed on all enrolled participants. | Posted | | Number | | percentage of participants | | Baseline until death due to any cause (up to 1 year) | | | | ID | Title | Description |
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| OG000 | Metastatic Renal Cell Carcinoma (mRCC) Cohort | Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months. |
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| Secondary | Time to Treatment Failure | Time to treatment failure was defined as the time from the start of treatment to the date of disease progression or date of permanent discontinuation. PD as per RECIST version 1.1 was defined as at least a 20% increase in the sum of longest dimensions of target lesions, reference to the smallest sum of the longest dimensions recorded since the treatment started, or the appearance of one or more new lesions or increase of at least 5 mm in addition to the relative increase of 20%. | Analysis was performed on all enrolled participants. Here, "overall number of participants analysed", indicates participants evaluable for this outcome measure. | Posted | | Median | Full Range | months | | Baseline until disease progression or discontinuation, due to any cause (up to 33 months) | | | | ID | Title | Description |
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| OG000 | Metastatic Renal Cell Carcinoma (mRCC) Cohort | Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months. |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received disease treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant and jeopardized the participants or required treatment to prevent other AE outcomes for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment emergent AEs were events which occurred between start of disease treatment and up to Month 12 follow-up visit, that were absent before treatment or that worsened relative to pre-treatment state. AEs included both non-SAE and SAEs. | Analysis was performed on all enrolled participants. | Posted | | Count of Participants | | Participants | | Baseline up to 12 months | | | | ID | Title | Description |
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| OG000 | Metastatic Renal Cell Carcinoma (mRCC) Cohort | Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months. |
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| Secondary | Number of Participants With Grade 3 or Higher Severe Adverse Events (AEs) Based on NCI CTCAE Version 4.03 | An AE was any untoward medical occurrence in a participant who received disease treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant and jeopardized the participants or required treatment to prevent other AE outcomes for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs were graded according to the National Cancer Institute- Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 and coded using the Medical Dictionary for Regulatory Activities (MedDRA) as Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe, Grade 4: Life threatening, Grade 5: Death related to AE. AEs included both SAEs and non-SAEs. | Analysis was performed on all enrolled participants. | Posted | | Count of Participants | | Participants | | Baseline up to 12 months | | | | ID | Title | Description |
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| OG000 | Metastatic Renal Cell Carcinoma (mRCC) Cohort | Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months. |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (AEs) During Third Line Targeted Treatment | An AE was any untoward medical occurrence in a participant who received disease treatment without regard to possibility of causal relationship. Treatment emergent AEs during third line targeted treatment were events which occurred between first dose of third line targeted treatment and up to Month 12 follow-up visit, that were absent before treatment or that worsened relative to pre-treatment state. | Analysis was performed on all enrolled participants. | Posted | | Count of Participants | | Participants | | Baseline up to 12 months | | | | ID | Title | Description |
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| OG000 | Metastatic Renal Cell Carcinoma (mRCC) Cohort | Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months. |
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| Secondary | Number of Participants With Dose Modifications of Third-Line Treatment Due to Adverse Events | Number of participants that required dose modifications of third line treatment due to AEs were reported in this outcome measure. Dose modification was categorized as escalation (increase in dose), delay or interruptions (change in dose time or skipping any dose), reduction (decrease in dose). | Analysis was performed on all enrolled participants. Here, "Number analyzed, indicates participants evaluable for specified category". | Posted | | Count of Participants | | Participants | | Baseline up to Month 3, 6, 9 and 12 | | | | ID | Title | Description |
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| OG000 | Metastatic Renal Cell Carcinoma (mRCC) Cohort | Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months. |
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| Secondary | Correlation Coefficient Between Efficacy and Dose Modifications Due to AEs | | Analysis was performed on all enrolled participants. | Posted | | Number | | Correlation coefficient | | Baseline up to Month 12 follow-up visit | | | | ID | Title | Description |
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| OG000 | Metastatic Renal Cell Carcinoma (mRCC) Cohort | Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months. |
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| Secondary | Correlation Coefficient Between Efficacy and High Blood Pressure (>150 / 90 Millimeter of Mercury ) | | Analysis was performed on all enrolled participants. | Posted | | Number | | Correlation coefficient | | Baseline up to Month 12 follow-up visit | | | | ID | Title | Description |
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| OG000 | Metastatic Renal Cell Carcinoma (mRCC) Cohort | Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months. |
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