Trial Outcomes & Findings for Study of Patients With Metastatic and/or Advanced Renal Cell Carcinoma, Treated With Sunitinib/Axitinib. (NCT NCT04033991)
NCT ID: NCT04033991
Last Updated: 2023-04-06
Results Overview
PFS was duration measured from the first date of each treatment line to the date of disease progression (PD), end of treatment date or date of death. Participants who were on treatment were censored on 30 June 2018. If a participant stopped due to toxicity, the earliest date from the date of progression or end of treatment date was assigned. PD per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 was defined as at least a 20 percent (%) increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of one or more new lesions was also considered progression.
COMPLETED
684 participants
From start of treatment to PD, death or end of treatment, whichever occurred first, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years)
2023-04-06
Participant Flow
Data of participants treated with first-line sunitinib and/or second-line axitinib in real world settings for metastatic renal cell carcinoma (mRCC) and/or advanced renal cell carcinoma (aRCC), from 2002 until 30 June 2018, were retrieved from Christie National Health Service (NHS) database. Available data were extracted, curated and analyzed during approximately 1.2 years of this retrospective, observational study.
Participant milestones
| Measure |
Participants With mRCC and/or aRCC
Participants who met the selection criteria, diagnosed with mRCC and/or aRCC, received sunitinib as first-line treatment and/or axitinib as second-line treatment from 2002 till 30 June 2018, according to normal routine healthcare practice in real-world setting, were included in this study. Data of these participants were derived from Christie NHS database.
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|---|---|
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Overall Study
STARTED
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684
|
|
Overall Study
Participants Who Took First-line Sunitinib Therapy
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622
|
|
Overall Study
Participants Who Took Second-line Axitinib Therapy
|
121
|
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Overall Study
Participants Who Took First-line Sunitinib Therapy and Then Second-line Axitinib Therapy
|
59
|
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Overall Study
Participants Who Took Drugs Other Than Sunitinib as First-line and Then Second-line Axitinib Therapy
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62
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|
Overall Study
COMPLETED
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684
|
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Participants With mRCC and/or aRCC
n=684 Participants
Participants who met the selection criteria, diagnosed with mRCC and/or aRCC, received sunitinib as first-line treatment and/or axitinib as second-line treatment from 2002 till 30 June 2018, according to normal routine healthcare practice in real-world setting, were included in this study. Data of these participants were derived from Christie NHS database.
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|---|---|
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Age, Customized
Less than (<) 65 years
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301 Participants
n=684 Participants
|
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Age, Customized
Greater than or equal to (>=) 65 to <75 years
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247 Participants
n=684 Participants
|
|
Age, Customized
>=75 to <84 years
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124 Participants
n=684 Participants
|
|
Age, Customized
Greater than or equal to (>=) 85 years
|
12 Participants
n=684 Participants
|
|
Sex: Female, Male
Female
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234 Participants
n=684 Participants
|
|
Sex: Female, Male
Male
|
450 Participants
n=684 Participants
|
PRIMARY outcome
Timeframe: From start of treatment to PD, death or end of treatment, whichever occurred first, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years)Population: Analysis population included all eligible participants with mRCC and/or aRCC, received sunitinib as first-line treatment and/or axitinib as second-line treatment from 2002 till 30 June 2018.
PFS was duration measured from the first date of each treatment line to the date of disease progression (PD), end of treatment date or date of death. Participants who were on treatment were censored on 30 June 2018. If a participant stopped due to toxicity, the earliest date from the date of progression or end of treatment date was assigned. PD per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 was defined as at least a 20 percent (%) increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of one or more new lesions was also considered progression.
Outcome measures
| Measure |
Participants With mRCC and/or aRCC: First Line Sunitinib Treatment
n=622 Participants
Participants who met the selection criteria, diagnosed with mRCC and/or aRCC, received sunitinib as first-line treatment from 2002 till 30 June 2018, according to normal routine healthcare practice in real-world setting, were included in this reporting arm. Data of these participants were derived from Christie NHS database.
|
Participants With mRCC and/or aRCC: Second Line Axitinib Treatment
n=121 Participants
Participants who met the selection criteria, diagnosed with mRCC and/or aRCC, received axitinib as second-line treatment from 2002 till 30 June 2018, according to normal routine healthcare practice in real-world setting, were included in this reporting arm. Data of these participants were derived from Christie NHS database.
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|---|---|---|
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Progression Free Survival (PFS)
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8.394 Months
Interval 7.556 to 9.889
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6.177 Months
Interval 4.928 to 9.331
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PRIMARY outcome
Timeframe: From start of treatment to PD, death or end of treatment, whichever occurred first, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years)Population: Analysis population included all eligible participants with mRCC and/or aRCC, received sunitinib as first-line treatment and/or axitinib as second-line treatment from 2002 till 30 June 2018. Here "Number Analyzed" signifies number of participants evaluable for specified rows.
PFS: first date of each treatment line to the date of PD, end of treatment date or date of death. Participants who were on treatment were censored on 30 June 2018. If a participant stopped due to toxicity, the earliest date from date of PD or end of treatment date was assigned. MSKCC criteria had 5 risk factors: Karnofsky performance status (KPS) \<80% (ability to perform ordinary tasks, 0 \[dead\] -100 \[normal\]); time from diagnosis to start of systemic therapy \<12 months; hemoglobin \<lower limit of normal (LLN); lactate dehydrogenase 1.5\*upper limit of normal (ULN); corrected serum calcium \>10 milligram per deciliter (mg/dL). Present risk factors were added, and participants were stratified as: favorable (0 factor), intermediate (1-2 factors), poor (\>=3 factors). PD: \>=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of 1 or more new lesions was considered PD.
Outcome measures
| Measure |
Participants With mRCC and/or aRCC: First Line Sunitinib Treatment
n=622 Participants
Participants who met the selection criteria, diagnosed with mRCC and/or aRCC, received sunitinib as first-line treatment from 2002 till 30 June 2018, according to normal routine healthcare practice in real-world setting, were included in this reporting arm. Data of these participants were derived from Christie NHS database.
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Participants With mRCC and/or aRCC: Second Line Axitinib Treatment
n=121 Participants
Participants who met the selection criteria, diagnosed with mRCC and/or aRCC, received axitinib as second-line treatment from 2002 till 30 June 2018, according to normal routine healthcare practice in real-world setting, were included in this reporting arm. Data of these participants were derived from Christie NHS database.
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|---|---|---|
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Progression Free Survival (PFS): Memorial Sloan-Kettering Cancer Center (MSKCC) Stratification
Favorable
|
14.784 Months
Interval 11.729 to 20.008
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12.649 Months
Interval 4.895 to 15.639
|
|
Progression Free Survival (PFS): Memorial Sloan-Kettering Cancer Center (MSKCC) Stratification
Intermediate
|
8.986 Months
Interval 7.589 to 10.021
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8.903 Months
Interval 5.29 to 11.762
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Progression Free Survival (PFS): Memorial Sloan-Kettering Cancer Center (MSKCC) Stratification
Poor
|
2.628 Months
Interval 1.774 to 4.6
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1.610 Months
Interval 0.46 to 2.661
|
|
Progression Free Survival (PFS): Memorial Sloan-Kettering Cancer Center (MSKCC) Stratification
Unknown/missing (no information available)
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NA Months
Median and 95% confidence interval (CI) was not calculated as no information was available for these participants.
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NA Months
Median and 95% CI was not calculated as no information was available for these participants.
|
PRIMARY outcome
Timeframe: From start of treatment to PD, death or end of treatment, whichever occurred first, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years)Population: Analysis population included all eligible participants with mRCC and/or aRCC, received sunitinib as first-line treatment and/or axitinib as second-line treatment from 2002 till 30 June 2018. Here "Number Analyzed" signifies number of participants evaluable for specified rows.
PFS: duration measured from first date of each treatment line to the date of PD, end of treatment date or date of death. Participants who were on treatment were censored on 30 June 2018. If a participant stopped due to toxicity, the earliest date from date of PD or end of treatment date was assigned. IMDC criteria had 6 risk factors: KPS \<80% (ability to perform ordinary tasks, 0 \[dead\] -100 \[normal\]); time from diagnosis to start of systemic therapy \<12 months; corrected serum calcium \>10 mg/dL; neutrophils and platelets \>LLN; hemoglobin \<LLN. Present risk factors were added, and then participants were stratified as: favorable (0 factor), intermediate (1-2 factors), poor (\>=3 factors). PD: \>=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of 1 or more new lesions was also considered PD.
Outcome measures
| Measure |
Participants With mRCC and/or aRCC: First Line Sunitinib Treatment
n=622 Participants
Participants who met the selection criteria, diagnosed with mRCC and/or aRCC, received sunitinib as first-line treatment from 2002 till 30 June 2018, according to normal routine healthcare practice in real-world setting, were included in this reporting arm. Data of these participants were derived from Christie NHS database.
|
Participants With mRCC and/or aRCC: Second Line Axitinib Treatment
n=121 Participants
Participants who met the selection criteria, diagnosed with mRCC and/or aRCC, received axitinib as second-line treatment from 2002 till 30 June 2018, according to normal routine healthcare practice in real-world setting, were included in this reporting arm. Data of these participants were derived from Christie NHS database.
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|---|---|---|
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Progression Free Survival (PFS): International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) Stratification
Favorable
|
13.979 Months
Interval 10.382 to 18.497
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12.649 Months
Interval 5.749 to 15.639
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Progression Free Survival (PFS): International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) Stratification
Intermediate
|
9.955 Months
Interval 8.082 to 12.156
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7.162 Months
Interval 5.158 to 10.842
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Progression Free Survival (PFS): International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) Stratification
Poor
|
5.569 Months
Interval 4.83 to 6.275
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2.990 Months
Interval 1.708 to 5.651
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|
Progression Free Survival (PFS): International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) Stratification
Unknown/missing (no information available)
|
NA Months
Median and 95% CI was not calculated as no information was available for these participants.
|
NA Months
Median and 95% CI was not calculated as no information was available for these participants.
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SECONDARY outcome
Timeframe: From index date until death, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years)Population: Analysis population included all eligible participants with mRCC and/or aRCC, received sunitinib as first-line treatment and/or axitinib as second-line treatment from 2002 till 30 June 2018.
OS was defined as the time between the index date and the date of death from any cause. Participants who were still alive at the study end date or the last visit date available were censored. Index date: date of initiation of first-line sunitinib therapy and second-line axitinib therapy.
Outcome measures
| Measure |
Participants With mRCC and/or aRCC: First Line Sunitinib Treatment
n=622 Participants
Participants who met the selection criteria, diagnosed with mRCC and/or aRCC, received sunitinib as first-line treatment from 2002 till 30 June 2018, according to normal routine healthcare practice in real-world setting, were included in this reporting arm. Data of these participants were derived from Christie NHS database.
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Participants With mRCC and/or aRCC: Second Line Axitinib Treatment
n=121 Participants
Participants who met the selection criteria, diagnosed with mRCC and/or aRCC, received axitinib as second-line treatment from 2002 till 30 June 2018, according to normal routine healthcare practice in real-world setting, were included in this reporting arm. Data of these participants were derived from Christie NHS database.
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|---|---|---|
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Overall Survival (OS)
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18.333 Months
Interval 15.77 to 20.435
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15.836 Months
Interval 12.025 to 20.37
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SECONDARY outcome
Timeframe: From index date until death, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years)Population: Analysis population included all eligible participants with mRCC and/or aRCC, received sunitinib as first-line treatment and/or axitinib as second-line treatment from 2002 till 30 June 2018. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.
OS was defined as the time between the index date and the date of death from any cause. Participants who were still alive at the study end date or the last visit date available were censored. MSKCC criteria had 5 risk factors: KPS \<80% (ability to perform ordinary tasks, 0 \[dead\] -100 \[normal\]); time from diagnosis to start of systemic therapy \<12 months; hemoglobin \<LLN; lactate dehydrogenase 1.5\* ULN; corrected serum calcium \>10.0 mg/dL. Present risk factors were added, and then participants were stratified in following prognosis group: favorable (0 factor), intermediate (1-2 factors), poor (\>=3 factors), unknown/missing = no information available. Index date: date of initiation of first-line sunitinib therapy and second-line axitinib therapy.
Outcome measures
| Measure |
Participants With mRCC and/or aRCC: First Line Sunitinib Treatment
n=622 Participants
Participants who met the selection criteria, diagnosed with mRCC and/or aRCC, received sunitinib as first-line treatment from 2002 till 30 June 2018, according to normal routine healthcare practice in real-world setting, were included in this reporting arm. Data of these participants were derived from Christie NHS database.
|
Participants With mRCC and/or aRCC: Second Line Axitinib Treatment
n=121 Participants
Participants who met the selection criteria, diagnosed with mRCC and/or aRCC, received axitinib as second-line treatment from 2002 till 30 June 2018, according to normal routine healthcare practice in real-world setting, were included in this reporting arm. Data of these participants were derived from Christie NHS database.
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|---|---|---|
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Overall Survival (OS): Memorial Sloan-Kettering Cancer Center (MSKCC) Stratification
Favorable
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40.246 Months
Interval 30.357 to 47.54
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NA Months
Median and 95% CI was not estimable due to low number of participants with events.
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|
Overall Survival (OS): Memorial Sloan-Kettering Cancer Center (MSKCC) Stratification
Intermediate
|
18.497 Months
Interval 15.934 to 20.468
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16.164 Months
Interval 11.63 to 20.37
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|
Overall Survival (OS): Memorial Sloan-Kettering Cancer Center (MSKCC) Stratification
Poor
|
5.322 Months
Interval 3.614 to 6.998
|
2.694 Months
Interval 1.84 to 8.444
|
|
Overall Survival (OS): Memorial Sloan-Kettering Cancer Center (MSKCC) Stratification
Unknown/missing (no information available)
|
NA Months
Median and 95% CI was not calculated as no information was available for these participants.
|
NA Months
Median and 95% CI was not calculated as no information was available for these participants.
|
SECONDARY outcome
Timeframe: From index date until death, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years)Population: Analysis population included all eligible participants with mRCC and/or aRCC, received sunitinib as first-line treatment and/or axitinib as second-line treatment from 2002 till 30 June 2018. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.
OS was defined as the time between the index date and the date of death from any cause. Participants who were still alive at the study end date or the last visit date available were censored. IMDC criteria had 6 risk factors: KPS \<80% (ability to perform ordinary tasks, 0 \[dead\] -100 \[normal\]); time from diagnosis to start of systemic therapy \<12 months; corrected serum calcium \>10.0 mg/dL; neutrophils and platelets \>LLN and hemoglobin \<LLN. Present risk factors were added, and then participants were stratified in following prognosis group: favorable (0 factor), intermediate (1-2 factors), poor (\>=3 factors), unknown/missing =no information available. Index date: date of initiation of first-line sunitinib therapy and second-line axitinib therapy.
Outcome measures
| Measure |
Participants With mRCC and/or aRCC: First Line Sunitinib Treatment
n=622 Participants
Participants who met the selection criteria, diagnosed with mRCC and/or aRCC, received sunitinib as first-line treatment from 2002 till 30 June 2018, according to normal routine healthcare practice in real-world setting, were included in this reporting arm. Data of these participants were derived from Christie NHS database.
|
Participants With mRCC and/or aRCC: Second Line Axitinib Treatment
n=121 Participants
Participants who met the selection criteria, diagnosed with mRCC and/or aRCC, received axitinib as second-line treatment from 2002 till 30 June 2018, according to normal routine healthcare practice in real-world setting, were included in this reporting arm. Data of these participants were derived from Christie NHS database.
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|---|---|---|
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Overall Survival (OS): International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) Stratification
Favorable
|
34.103 Months
Interval 26.382 to 46.127
|
NA Months
Median and 95% CI was not estimable due to low number of participants with events.
|
|
Overall Survival (OS): International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) Stratification
Intermediate
|
20.435 Months
Interval 17.15 to 23.491
|
16.394 Months
Interval 12.287 to 21.947
|
|
Overall Survival (OS): International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) Stratification
Poor
|
9.347 Months
Interval 7.524 to 10.842
|
8.049 Months
Interval 4.764 to 18.168
|
|
Overall Survival (OS): International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) Stratification
Unknown/missing (no information available)
|
NA Months
Median and 95% CI was not calculated as no information was available for these participants.
|
NA Months
Median and 95% CI was not calculated as no information was available for these participants.
|
SECONDARY outcome
Timeframe: Start of treatment till BOR of CR, PR, PD, SD, Surgical CR, or death/initiation of new therapy, whichever occurred first; from 2002 to 30 June 2018, anytime in these 16 years (data retrieved and observed retrospectively for approximately 1.2 years)Population: Analysis population included all eligible participants with mRCC and/or aRCC, received sunitinib as first-line treatment and/or axitinib as second-line treatment from 2002 till 30 June 2018.
BOR was recorded for CR, PR, SD, PD and surgical CR. RECIST v1.1, a) CR: disappearance of target, non-target lesions and normalization of tumor markers. Pathological lymph nodes had short axis measures \<10mm; b) PR: \>=30% decrease in sum of measures (longest diameter for tumor lesions, short axis measure for nodes) of target lesions, taking reference baseline sum of diameters. Non-target lesions must be non-PD; c) PD: \>=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5mm. Appearance of 1 or more new lesions; d) SD: neither shrinkage for CR/PR nor increase for PD taking as reference smallest sum of longest diameters since treatment start; e) Surgical CR: disappearance of target, non-target lesions, normalization of tumor markers, pathological lymph nodes had short axis measuring \<10mm as result of surgery. Alive participants with no events were censored at final study cutoff date.
Outcome measures
| Measure |
Participants With mRCC and/or aRCC: First Line Sunitinib Treatment
n=622 Participants
Participants who met the selection criteria, diagnosed with mRCC and/or aRCC, received sunitinib as first-line treatment from 2002 till 30 June 2018, according to normal routine healthcare practice in real-world setting, were included in this reporting arm. Data of these participants were derived from Christie NHS database.
|
Participants With mRCC and/or aRCC: Second Line Axitinib Treatment
n=121 Participants
Participants who met the selection criteria, diagnosed with mRCC and/or aRCC, received axitinib as second-line treatment from 2002 till 30 June 2018, according to normal routine healthcare practice in real-world setting, were included in this reporting arm. Data of these participants were derived from Christie NHS database.
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|---|---|---|
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Number of Participants With Best Overall Response (BOR) for Complete Response (CR), Partial Response (PR), Stable Disease (SD), PD and Surgical CR as Per RECIST v 1.1
CR
|
19 Participants
|
0 Participants
|
|
Number of Participants With Best Overall Response (BOR) for Complete Response (CR), Partial Response (PR), Stable Disease (SD), PD and Surgical CR as Per RECIST v 1.1
PR
|
127 Participants
|
17 Participants
|
|
Number of Participants With Best Overall Response (BOR) for Complete Response (CR), Partial Response (PR), Stable Disease (SD), PD and Surgical CR as Per RECIST v 1.1
SD
|
252 Participants
|
50 Participants
|
|
Number of Participants With Best Overall Response (BOR) for Complete Response (CR), Partial Response (PR), Stable Disease (SD), PD and Surgical CR as Per RECIST v 1.1
PD
|
145 Participants
|
33 Participants
|
|
Number of Participants With Best Overall Response (BOR) for Complete Response (CR), Partial Response (PR), Stable Disease (SD), PD and Surgical CR as Per RECIST v 1.1
Surgical CR
|
2 Participants
|
0 Participants
|
|
Number of Participants With Best Overall Response (BOR) for Complete Response (CR), Partial Response (PR), Stable Disease (SD), PD and Surgical CR as Per RECIST v 1.1
NA/Missing (no clinical response recorded in data base)
|
77 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: From start of treatment until CR,PR,PD,death/initiation of new therapy, whichever occurred first, from inception of database(2002) until 30 June 2018, anytime in these 16 years (from data retrieved and observed retrospectively for approximately 1.2 years)Population: Analysis population included all eligible participants with mRCC and/or aRCC, received sunitinib as first-line treatment and/or axitinib as second-line treatment from 2002 till 30 June 2018.
ORR was defined as the percentage of participants who achieved a BOR of CR or PR as per RECIST v1.1. CR was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures \<10 mm. PR was defined as at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference baseline sum of diameters. Non-target lesions must be non-PD. PD was defined as at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was considered progression. Alive participants who did not have event were censored at final study cutoff date.
Outcome measures
| Measure |
Participants With mRCC and/or aRCC: First Line Sunitinib Treatment
n=622 Participants
Participants who met the selection criteria, diagnosed with mRCC and/or aRCC, received sunitinib as first-line treatment from 2002 till 30 June 2018, according to normal routine healthcare practice in real-world setting, were included in this reporting arm. Data of these participants were derived from Christie NHS database.
|
Participants With mRCC and/or aRCC: Second Line Axitinib Treatment
n=121 Participants
Participants who met the selection criteria, diagnosed with mRCC and/or aRCC, received axitinib as second-line treatment from 2002 till 30 June 2018, according to normal routine healthcare practice in real-world setting, were included in this reporting arm. Data of these participants were derived from Christie NHS database.
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|---|---|---|
|
Objective Response Rate (ORR)
|
23.5 Percentage of participants
Interval 20.2 to 27.0
|
14.0 Percentage of participants
Interval 8.4 to 21.5
|
SECONDARY outcome
Timeframe: From date of first documented CR/PR until PD/death/initiation of new therapy, whichever occurred first, from inception of database(2002) until 30 June 2018, anytime in these 16years (data retrieved and observed retrospectively for approximately 1.2 years)Population: Analysis population included all eligible participants with mRCC and/or aRCC, received sunitinib as first-line treatment and/or axitinib as second-line treatment from 2002 till 30 June 2018. Required information for this outcome measure was not present in Christie NHS database. Hence, data could not be collected and analyzed for this outcome measure.
DOR was defined as the time between the date of the first documented confirmed response (PR or CR) and the date of the first documented progression or death due to any cause. Alive participants who did not have event were censored at final study cutoff date. As per RECIST v1.1: CR was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes short axis measures \<10 mm. PR was defined as at least 30% decrease in sum of measures (tumor lesions- longest diameter and nodes- short axis) of target lesions, taking as reference baseline sum of diameters. PD was defined as at least 20% increase in sum of diameters of measured lesions taking as references smallest sum of diameters recorded on study (including baseline) and an absolute increase of \>=5 mm or appearance of at least 1 new lesion.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From start of the treatment until end of treatment, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years)Population: Analysis population included all eligible participants with mRCC and/or aRCC, received sunitinib as first-line treatment and/or axitinib as second-line treatment from 2002 till 30 June 2018.
TTD was defined as the time between initiation of treatment to the end of treatment for any reason including PD, death, and lost-to follow up. Participants were censored on the study end date or at last office visit date without clinical or radiographic evidence of PD, whichever occurred first.
Outcome measures
| Measure |
Participants With mRCC and/or aRCC: First Line Sunitinib Treatment
n=622 Participants
Participants who met the selection criteria, diagnosed with mRCC and/or aRCC, received sunitinib as first-line treatment from 2002 till 30 June 2018, according to normal routine healthcare practice in real-world setting, were included in this reporting arm. Data of these participants were derived from Christie NHS database.
|
Participants With mRCC and/or aRCC: Second Line Axitinib Treatment
n=121 Participants
Participants who met the selection criteria, diagnosed with mRCC and/or aRCC, received axitinib as second-line treatment from 2002 till 30 June 2018, according to normal routine healthcare practice in real-world setting, were included in this reporting arm. Data of these participants were derived from Christie NHS database.
|
|---|---|---|
|
Time to Treatment Discontinuation (TTD)
|
8.509 Months
Interval 7.589 to 9.889
|
6.899 Months
Interval 5.158 to 9.528
|
SECONDARY outcome
Timeframe: From start of the treatment until end of treatment, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years)Population: Analysis population included all eligible participants with mRCC and/or aRCC, received sunitinib as first-line treatment and/or axitinib as second-line treatment from 2002 till 30 June 2018. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.
TTD was defined as the time between initiation of treatment to the end of treatment for any reason including PD, death, and lost-to follow up. Participants were censored on the study end date or at last office visit date without clinical or radiographic evidence of PD, whichever occurred first. MSKCC criteria had following 5 risk factors: KPS \<80% (ability to perform ordinary tasks, 0 \[dead\] -100 \[normal\]); time from diagnosis to start of systemic therapy \<12 months; hemoglobin \<LLN; lactate dehydrogenase 1.5\*ULN; corrected serum calcium \>10.0 mg/dL. Present risk factors were added, and then participants were stratified in following prognosis group: favorable (0 factor), intermediate (1-2 factors), poor (\>=3 factors), unknown/missing = no information available.
Outcome measures
| Measure |
Participants With mRCC and/or aRCC: First Line Sunitinib Treatment
n=622 Participants
Participants who met the selection criteria, diagnosed with mRCC and/or aRCC, received sunitinib as first-line treatment from 2002 till 30 June 2018, according to normal routine healthcare practice in real-world setting, were included in this reporting arm. Data of these participants were derived from Christie NHS database.
|
Participants With mRCC and/or aRCC: Second Line Axitinib Treatment
n=121 Participants
Participants who met the selection criteria, diagnosed with mRCC and/or aRCC, received axitinib as second-line treatment from 2002 till 30 June 2018, according to normal routine healthcare practice in real-world setting, were included in this reporting arm. Data of these participants were derived from Christie NHS database.
|
|---|---|---|
|
Time to Treatment Discontinuation (TTD): Memorial Sloan-Kettering Cancer Center (MSKCC) Stratification
Favorable
|
15.836 Months
Interval 11.959 to 20.961
|
12.649 Months
Interval 4.895 to 16.099
|
|
Time to Treatment Discontinuation (TTD): Memorial Sloan-Kettering Cancer Center (MSKCC) Stratification
Intermediate
|
9.051 Months
Interval 7.589 to 10.119
|
8.903 Months
Interval 5.552 to 12.222
|
|
Time to Treatment Discontinuation (TTD): Memorial Sloan-Kettering Cancer Center (MSKCC) Stratification
Poor
|
2.760 Months
Interval 1.807 to 4.6
|
1.610 Months
Interval 0.69 to 2.924
|
|
Time to Treatment Discontinuation (TTD): Memorial Sloan-Kettering Cancer Center (MSKCC) Stratification
Unknown/missing (no information available)
|
NA Months
Median and 95% CI was not calculated as no information was available for these participants.
|
NA Months
Median and 95% CI was not calculated as no information was available for these participants.
|
SECONDARY outcome
Timeframe: From start of the treatment until end of treatment, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years)Population: Analysis population included all eligible participants with mRCC and/or aRCC, received sunitinib as first-line treatment and/or axitinib as second-line treatment from 2002 till 30 June 2018. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.
TTD was defined as the time between initiation of treatment to the end of treatment for any reason including PD, death, and lost-to follow up. Participants were censored on the study end date or at last office visit date without clinical or radiographic evidence of PD, whichever occurred first. IMDC criteria had following 6 risk factors: KPS \<80% (ability to perform ordinary tasks, 0 \[dead\] -100 \[normal\]); time from diagnosis to start of systemic therapy \<12 months; corrected serum calcium \>10.0 mg/dL; neutrophils and platelets \>LLN and hemoglobin \<LLN. Present risk factors were added, and then participants were stratified in following prognosis group: favorable (0 factor), intermediate (1-2 factors), poor (\>=3 factors), unknown/missing =no information available.
Outcome measures
| Measure |
Participants With mRCC and/or aRCC: First Line Sunitinib Treatment
n=622 Participants
Participants who met the selection criteria, diagnosed with mRCC and/or aRCC, received sunitinib as first-line treatment from 2002 till 30 June 2018, according to normal routine healthcare practice in real-world setting, were included in this reporting arm. Data of these participants were derived from Christie NHS database.
|
Participants With mRCC and/or aRCC: Second Line Axitinib Treatment
n=121 Participants
Participants who met the selection criteria, diagnosed with mRCC and/or aRCC, received axitinib as second-line treatment from 2002 till 30 June 2018, according to normal routine healthcare practice in real-world setting, were included in this reporting arm. Data of these participants were derived from Christie NHS database.
|
|---|---|---|
|
Time to Treatment Discontinuation (TTD): International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) Stratification
Favorable
|
15.129 Months
Interval 10.809 to 20.731
|
12.649 Months
Interval 6.012 to 16.099
|
|
Time to Treatment Discontinuation (TTD): International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) Stratification
Intermediate
|
9.988 Months
Interval 8.082 to 12.189
|
7.359 Months
Interval 5.158 to 10.842
|
|
Time to Treatment Discontinuation (TTD): International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) Stratification
Poor
|
5.651 Months
Interval 4.83 to 6.472
|
3.680 Months
Interval 1.906 to 7.162
|
|
Time to Treatment Discontinuation (TTD): International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) Stratification
Unknown/missing (no information available)
|
NA Months
Median and 95% CI was not calculated as no information was available for these participants.
|
NA Months
Median and 95% CI was not calculated as no information was available for these participants.
|
SECONDARY outcome
Timeframe: 6 months from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years)Population: Analysis population included all eligible participants with mRCC and/or aRCC, received sunitinib as first-line treatment and/or axitinib as second-line treatment from 2002 till 30 June 2018. Required information for this outcome measure was not present in Christie NHS database. Hence, data could not be collected and analyzed for this outcome measure.
DRR was determined as the percentage of participants with objective response (CR or PR) with a duration of at least 6 months. As per RECIST v1.1: CR was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes short axis measures \<10 mm. PR was defined as at least 30% decrease in sum of measures (tumor lesions- longest diameter and nodes- short axis) of target lesions, taking as reference baseline sum of diameters.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (data retrieved and observed retrospectively for approximately 1.2 years)Population: Analysis population included all eligible participants with mRCC and/or aRCC, received sunitinib as first-line treatment and/or axitinib as second-line treatment from 2002 till 30 June 2018.
Outcome measures
| Measure |
Participants With mRCC and/or aRCC: First Line Sunitinib Treatment
n=622 Participants
Participants who met the selection criteria, diagnosed with mRCC and/or aRCC, received sunitinib as first-line treatment from 2002 till 30 June 2018, according to normal routine healthcare practice in real-world setting, were included in this reporting arm. Data of these participants were derived from Christie NHS database.
|
Participants With mRCC and/or aRCC: Second Line Axitinib Treatment
n=121 Participants
Participants who met the selection criteria, diagnosed with mRCC and/or aRCC, received axitinib as second-line treatment from 2002 till 30 June 2018, according to normal routine healthcare practice in real-world setting, were included in this reporting arm. Data of these participants were derived from Christie NHS database.
|
|---|---|---|
|
Number of Participants Who Started Systemic Therapy Within 1 Year of Diagnosis
|
367 Participants
|
63 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (data retrieved and observed retrospectively for approximately 1.2 years)Population: Analysis population included all eligible participants with mRCC and/or aRCC, received sunitinib as first-line treatment and/or axitinib as second-line treatment from 2002 till 30 June 2018.
KPS: used for rating participant activities of daily living on scale from 0-100, higher score = participant is better able to carry out daily activities. Score range: 100 = normal no complaints; no disease evidence, 90 = able to carry normal activity; minor signs/symptoms of disease, 80 = normal activity with effort; some signs/symptoms, 70 = cares for self; unable to carry on normal activity, 60 = requires occasional assistance, but able to care for most personal needs, 50 = requires considerable assistance and frequent medical care, 40 = disabled; requires special care, assistance, 30 = severely disabled; hospital admission is indicated although death not imminent, 20 = very sick; hospital admission necessary, 10 = moribund; fatal processes progressing rapidly and 0 = dead. The lower the score the worse is survival for most serious illnesses. Here, number of participants with KPS \<80% were reported.
Outcome measures
| Measure |
Participants With mRCC and/or aRCC: First Line Sunitinib Treatment
n=622 Participants
Participants who met the selection criteria, diagnosed with mRCC and/or aRCC, received sunitinib as first-line treatment from 2002 till 30 June 2018, according to normal routine healthcare practice in real-world setting, were included in this reporting arm. Data of these participants were derived from Christie NHS database.
|
Participants With mRCC and/or aRCC: Second Line Axitinib Treatment
n=121 Participants
Participants who met the selection criteria, diagnosed with mRCC and/or aRCC, received axitinib as second-line treatment from 2002 till 30 June 2018, according to normal routine healthcare practice in real-world setting, were included in this reporting arm. Data of these participants were derived from Christie NHS database.
|
|---|---|---|
|
Number of Participants With Karnofsky Performance Status (KPS) Less Than 80 Percent (%)
|
89 Participants
|
28 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (data retrieved and observed retrospectively for approximately 1.2 years)Population: Analysis population included all eligible participants with mRCC and/or aRCC, received sunitinib as first-line treatment and/or axitinib as second-line treatment from 2002 till 30 June 2018.
In this outcome measure number of participants with hemoglobin less than LLN were reported. For male participants LLN was 130 grams per liter and for female participants LLN was 115 grams per liter.
Outcome measures
| Measure |
Participants With mRCC and/or aRCC: First Line Sunitinib Treatment
n=622 Participants
Participants who met the selection criteria, diagnosed with mRCC and/or aRCC, received sunitinib as first-line treatment from 2002 till 30 June 2018, according to normal routine healthcare practice in real-world setting, were included in this reporting arm. Data of these participants were derived from Christie NHS database.
|
Participants With mRCC and/or aRCC: Second Line Axitinib Treatment
n=121 Participants
Participants who met the selection criteria, diagnosed with mRCC and/or aRCC, received axitinib as second-line treatment from 2002 till 30 June 2018, according to normal routine healthcare practice in real-world setting, were included in this reporting arm. Data of these participants were derived from Christie NHS database.
|
|---|---|---|
|
Number of Participants With Hemoglobin Less Than Lower Limit of Normal (LLN)
|
322 Participants
|
72 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (data retrieved and observed retrospectively for approximately 1.2 years)Population: Analysis population included all eligible participants with mRCC and/or aRCC, received sunitinib as first-line treatment and/or axitinib as second-line treatment from 2002 till 30 June 2018.
Number of participants with serum calcium \>ULN (3.00 millimole per liter \[mmol/L\]), neutrophils \>ULN (7.5 \*10\^9/L), platelets \>ULN (400 \*10\^9/L), lactate dehydrogenase \>1.5\*ULN were reported in this outcome measure.
Outcome measures
| Measure |
Participants With mRCC and/or aRCC: First Line Sunitinib Treatment
n=622 Participants
Participants who met the selection criteria, diagnosed with mRCC and/or aRCC, received sunitinib as first-line treatment from 2002 till 30 June 2018, according to normal routine healthcare practice in real-world setting, were included in this reporting arm. Data of these participants were derived from Christie NHS database.
|
Participants With mRCC and/or aRCC: Second Line Axitinib Treatment
n=121 Participants
Participants who met the selection criteria, diagnosed with mRCC and/or aRCC, received axitinib as second-line treatment from 2002 till 30 June 2018, according to normal routine healthcare practice in real-world setting, were included in this reporting arm. Data of these participants were derived from Christie NHS database.
|
|---|---|---|
|
Number of Participants With Serum Calcium >Upper Limit of Normal (ULN), Neutrophil >ULN, Platelets >ULN and Lactate Dehydrogenase >1.5*ULN
Serum Calcium >ULN
|
45 Participants
|
7 Participants
|
|
Number of Participants With Serum Calcium >Upper Limit of Normal (ULN), Neutrophil >ULN, Platelets >ULN and Lactate Dehydrogenase >1.5*ULN
Neutrophil >ULN
|
132 Participants
|
11 Participants
|
|
Number of Participants With Serum Calcium >Upper Limit of Normal (ULN), Neutrophil >ULN, Platelets >ULN and Lactate Dehydrogenase >1.5*ULN
Platelets >ULN
|
181 Participants
|
28 Participants
|
|
Number of Participants With Serum Calcium >Upper Limit of Normal (ULN), Neutrophil >ULN, Platelets >ULN and Lactate Dehydrogenase >1.5*ULN
Lactate Dehydrogenase >1.5*ULN
|
368 Participants
|
67 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (data retrieved and observed retrospectively for approximately 1.2 years)Population: Analysis population included all eligible participants with mRCC and/or aRCC, received sunitinib as first-line treatment and/or axitinib as second-line treatment from 2002 till 30 June 2018.
The four-tiered Fuhrman grading evaluates nuclear size, nuclear shape and presence of nucleolar prominence. Grade 1: small (=10 micrometer \[mcm\]) nuclear diameter, round/uniform nuclear shape and absent/inconspicuous nucleoli; Grade 2: large (=15 mcm) nuclear diameter, irregular outline nuclear shape and visible at \*400 magnification nucleoli; Grade 3: larger (=20 mcm) nuclear diameter, obvious irregular outline nuclear shape and visible and prominent at \*100 magnification nucleoli; Grade 4: grade 3 plus bizarre multilobed nuclei +/- spindle cells.
Outcome measures
| Measure |
Participants With mRCC and/or aRCC: First Line Sunitinib Treatment
n=622 Participants
Participants who met the selection criteria, diagnosed with mRCC and/or aRCC, received sunitinib as first-line treatment from 2002 till 30 June 2018, according to normal routine healthcare practice in real-world setting, were included in this reporting arm. Data of these participants were derived from Christie NHS database.
|
Participants With mRCC and/or aRCC: Second Line Axitinib Treatment
n=121 Participants
Participants who met the selection criteria, diagnosed with mRCC and/or aRCC, received axitinib as second-line treatment from 2002 till 30 June 2018, according to normal routine healthcare practice in real-world setting, were included in this reporting arm. Data of these participants were derived from Christie NHS database.
|
|---|---|---|
|
Number of Participants Per Tumor Fuhrman Grades
1
|
8 Participants
|
0 Participants
|
|
Number of Participants Per Tumor Fuhrman Grades
2
|
113 Participants
|
21 Participants
|
|
Number of Participants Per Tumor Fuhrman Grades
3
|
141 Participants
|
34 Participants
|
|
Number of Participants Per Tumor Fuhrman Grades
4
|
137 Participants
|
38 Participants
|
|
Number of Participants Per Tumor Fuhrman Grades
Missing (no information available)
|
223 Participants
|
28 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (data retrieved and observed retrospectively for approximately 1.2 years)Population: Analysis population included all eligible participants with mRCC and/or aRCC, received sunitinib as first-line treatment and/or axitinib as second-line treatment from 2002 till 30 June 2018.
In this outcome measure, number of participants were classified according to tumor subtype as clear cell, non-clear cell and unknown/missing.
Outcome measures
| Measure |
Participants With mRCC and/or aRCC: First Line Sunitinib Treatment
n=622 Participants
Participants who met the selection criteria, diagnosed with mRCC and/or aRCC, received sunitinib as first-line treatment from 2002 till 30 June 2018, according to normal routine healthcare practice in real-world setting, were included in this reporting arm. Data of these participants were derived from Christie NHS database.
|
Participants With mRCC and/or aRCC: Second Line Axitinib Treatment
n=121 Participants
Participants who met the selection criteria, diagnosed with mRCC and/or aRCC, received axitinib as second-line treatment from 2002 till 30 June 2018, according to normal routine healthcare practice in real-world setting, were included in this reporting arm. Data of these participants were derived from Christie NHS database.
|
|---|---|---|
|
Number of Participants With Tumor Subtype
Clear cell
|
484 Participants
|
102 Participants
|
|
Number of Participants With Tumor Subtype
Non-clear cell
|
54 Participants
|
7 Participants
|
|
Number of Participants With Tumor Subtype
Unknown/missing (no information available)
|
84 Participants
|
12 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From start of treatment until death, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years)Population: Minimum criteria for reporting an AE (i.e. identifiable participant, identifiable reporter, a suspect product, and event) could not met, hence, adverse events were not collected and reported.
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study treatment.
Outcome measures
Outcome data not reported
Adverse Events
Participants With mRCC and/or aRCC: First Line Sunitinib Treatment
Participants With mRCC and/or aRCC: Second Line Axitinib Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER