Trial Outcomes & Findings for A Study to Describe the Kidney Cancer Patient Population Treatment, and Results in the Hospital District of Southwest Finland. (NCT NCT05363072)
NCT ID: NCT05363072
Last Updated: 2024-10-01
Results Overview
Number of participants according to co-diagnoses 3 years before participant's index were reported in this outcome measure. Index date was defined as the date of treatment initiation for mRCC. Co-diagnoses were based on International Classification of Diseases 10th revision (ICD-10) codes. One participant may have more than one co-diagnoses.
COMPLETED
1112 participants
3 years prior to index date
2024-10-01
Participant Flow
This study included data from adult participants diagnosed with renal cell carcinoma (RCC) recorded in routine clinical practice and available in the medical records of the Hospital District of Southwest Finland (HDSF) data lake from January 2010 to December 2021.
A total of 1112 participants with incident RCC were included in the study. Data was evaluated over 1 month in this retrospective study.
Participant milestones
| Measure |
All Participants With RCC
This study included participants diagnosed with RCC (local or metastatic) whose medical records were available at HDSF data lake irrespective of whether they received treatment. Participants were followed up from first record of RCC (index) until death, moved outside of HDSF or up to 31-Dec-2021.
|
|---|---|
|
Overall Study
STARTED
|
1112
|
|
Overall Study
Treated Metastatic RCC Participants (mRCC)
|
191
|
|
Overall Study
Not Treated Metastatic RCC Participants
|
145
|
|
Overall Study
COMPLETED
|
1112
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Baseline characteristics by cohort
| Measure |
All Participants With RCC
n=1112 Participants
This study included participants diagnosed with RCC (local or metastatic) whose medical records were available at HDSF data lake irrespective of whether they received treatment. Participants were followed up from first record of RCC (index) until death, moved outside of HDSF or up to 31-Dec-2021.
|
|---|---|
|
Age, Continuous
All RCC participants
|
69.3 Years
STANDARD_DEVIATION 12.0 • n=1112 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
|
Age, Continuous
Treated mRCC participants
|
67.7 Years
STANDARD_DEVIATION 8.5 • n=191 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
|
Age, Continuous
Not-treated mRCC participants
|
74.0 Years
STANDARD_DEVIATION 11.7 • n=145 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
|
Sex: Female, Male
All RCC participants · Female
|
418 Participants
n=1112 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
|
Sex: Female, Male
All RCC participants · Male
|
694 Participants
n=1112 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
|
Sex: Female, Male
Treated mRCC participants · Female
|
68 Participants
n=191 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
|
Sex: Female, Male
Treated mRCC participants · Male
|
123 Participants
n=191 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
|
Sex: Female, Male
Not-treated mRCC participants · Female
|
57 Participants
n=145 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
|
Sex: Female, Male
Not-treated mRCC participants · Male
|
88 Participants
n=145 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
PRIMARY outcome
Timeframe: 3 years prior to index datePopulation: All eligible advanced/metastatic RCC participants who initiated treatment for mRCC were included. This analysis was planned only in the treated mRCC participants.
Number of participants according to co-diagnoses 3 years before participant's index were reported in this outcome measure. Index date was defined as the date of treatment initiation for mRCC. Co-diagnoses were based on International Classification of Diseases 10th revision (ICD-10) codes. One participant may have more than one co-diagnoses.
Outcome measures
| Measure |
All Participants With RCC
n=191 Participants
This study included participants diagnosed with RCC (local or metastatic) whose medical records were available at HDSF data lake irrespective of whether they received treatment. Participants were followed up from first record of RCC (index) until death, moved outside of HDSF or up to 31-Dec-2021.
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|---|---|
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Number of Participants According to Co-Diagnoses Before Index
Infection
|
139 Participants
|
|
Number of Participants According to Co-Diagnoses Before Index
D41 Neoplasm of uncertain or unknown behavior of urinary organs
|
45 Participants
|
|
Number of Participants According to Co-Diagnoses Before Index
I10 Essential (primary) hypertension
|
41 Participants
|
|
Number of Participants According to Co-Diagnoses Before Index
R91 Abnormal findings on diagnostic imaging of lung
|
26 Participants
|
|
Number of Participants According to Co-Diagnoses Before Index
R31 Unspecified hematuria
|
22 Participants
|
|
Number of Participants According to Co-Diagnoses Before Index
E11 Non-insulin-dependent diabetes mellitus
|
17 Participants
|
|
Number of Participants According to Co-Diagnoses Before Index
E78 Disorders of lipoprotein metabolism and other lipidaemias
|
16 Participants
|
|
Number of Participants According to Co-Diagnoses Before Index
I48 Atrial fibrillation and flutter
|
14 Participants
|
|
Number of Participants According to Co-Diagnoses Before Index
G47 Sleep disorders
|
13 Participants
|
|
Number of Participants According to Co-Diagnoses Before Index
I26 Pulmonary embolism
|
12 Participants
|
|
Number of Participants According to Co-Diagnoses Before Index
H25 Senile cataract
|
11 Participants
|
|
Number of Participants According to Co-Diagnoses Before Index
J18 Pneumonia, organism unspecified
|
11 Participants
|
|
Number of Participants According to Co-Diagnoses Before Index
N40 Hyperplasia of prostate
|
11 Participants
|
|
Number of Participants According to Co-Diagnoses Before Index
R07 Pain in throat and chest
|
11 Participants
|
|
Number of Participants According to Co-Diagnoses Before Index
R10 Abdominal and pelvic pain
|
11 Participants
|
|
Number of Participants According to Co-Diagnoses Before Index
M17 Gonarthrosis [arthrosis of knee]
|
10 Participants
|
PRIMARY outcome
Timeframe: Up to 3 years after index datePopulation: All eligible advanced/metastatic RCC participants who initiated treatment for mRCC were included. This analysis was planned only in the treated mRCC participants.
Number of participants according to co-diagnoses up to 3 years after participant's index were reported in this outcome measure. Index date was defined as the date of treatment initiation for mRCC. Co-diagnoses were based on ICD-10 codes. One participant may have more than one co-diagnoses.
Outcome measures
| Measure |
All Participants With RCC
n=191 Participants
This study included participants diagnosed with RCC (local or metastatic) whose medical records were available at HDSF data lake irrespective of whether they received treatment. Participants were followed up from first record of RCC (index) until death, moved outside of HDSF or up to 31-Dec-2021.
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|---|---|
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Number of Participants According to Co-Diagnoses After Index
R53 Malaise and fatigue
|
12 Participants
|
|
Number of Participants According to Co-Diagnoses After Index
G47 Sleep disorders
|
11 Participants
|
|
Number of Participants According to Co-Diagnoses After Index
R91 Abnormal findings on diagnostic imaging of lung
|
10 Participants
|
|
Number of Participants According to Co-Diagnoses After Index
Infection
|
144 Participants
|
|
Number of Participants According to Co-Diagnoses After Index
I10 Essential (primary) hypertension
|
32 Participants
|
|
Number of Participants According to Co-Diagnoses After Index
J18 Pneumonia, organism unspecified
|
28 Participants
|
|
Number of Participants According to Co-Diagnoses After Index
R50 Fever of other and unknown origin
|
28 Participants
|
|
Number of Participants According to Co-Diagnoses After Index
E11 Non-insulin-dependent diabetes mellitus
|
15 Participants
|
|
Number of Participants According to Co-Diagnoses After Index
R10 Abdominal and pelvic pain
|
15 Participants
|
|
Number of Participants According to Co-Diagnoses After Index
D41 Neoplasm of uncertain or unknown behavior of urinary organs
|
14 Participants
|
|
Number of Participants According to Co-Diagnoses After Index
F43 Reaction to severe stress, and adjustment disorders
|
14 Participants
|
|
Number of Participants According to Co-Diagnoses After Index
E87 Other disorders of fluid, electrolyte and acid-base balance
|
13 Participants
|
|
Number of Participants According to Co-Diagnoses After Index
M54 Dorsalgia
|
12 Participants
|
|
Number of Participants According to Co-Diagnoses After Index
R31 Unspecified hematuria
|
12 Participants
|
|
Number of Participants According to Co-Diagnoses After Index
R06 Abnormalities of breathing
|
12 Participants
|
PRIMARY outcome
Timeframe: At indexPopulation: All eligible participants were included. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
BMI of participants at index was reported in this outcome measure. Index date was defined as the date of treatment initiation for mRCC.
Outcome measures
| Measure |
All Participants With RCC
n=1112 Participants
This study included participants diagnosed with RCC (local or metastatic) whose medical records were available at HDSF data lake irrespective of whether they received treatment. Participants were followed up from first record of RCC (index) until death, moved outside of HDSF or up to 31-Dec-2021.
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|---|---|
|
Body Mass Index (BMI)
All RCC participants
|
27.3 Kilogram per meter square
Standard Deviation 5.3
|
|
Body Mass Index (BMI)
Treated mRCC participants
|
25.1 Kilogram per meter square
Standard Deviation 4.3
|
|
Body Mass Index (BMI)
Not-treated mRCC participants
|
26.5 Kilogram per meter square
Standard Deviation 5.9
|
PRIMARY outcome
Timeframe: Up to maximum of 12 years (retrospective data collection of 1 month)Population: All eligible advanced/metastatic RCC participants who initiated treatment for mRCC were included.
The number of outpatient visits and emergency room (ER) visits per patient year for all contacts, disease-specific contacts and other contacts were reported in this outcome measure. All contacts included disease specific contacts and other contacts. Per patient year was defined as total sum of events divided by the total sum of follow-up length of the participants.
Outcome measures
| Measure |
All Participants With RCC
n=191 Participants
This study included participants diagnosed with RCC (local or metastatic) whose medical records were available at HDSF data lake irrespective of whether they received treatment. Participants were followed up from first record of RCC (index) until death, moved outside of HDSF or up to 31-Dec-2021.
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|---|---|
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Mean Outpatient Visits and Emergent Room Visits Per Patient Year
ER visits: All contacts
|
0.28 Visits per patient year
Interval 0.19 to 0.38
|
|
Mean Outpatient Visits and Emergent Room Visits Per Patient Year
Outpatient visits: All contacts
|
29.37 Visits per patient year
Interval 26.46 to 32.64
|
|
Mean Outpatient Visits and Emergent Room Visits Per Patient Year
Outpatient visits: Disease-specific
|
19.29 Visits per patient year
Interval 17.36 to 21.52
|
|
Mean Outpatient Visits and Emergent Room Visits Per Patient Year
Outpatient visits: Other contacts
|
10.07 Visits per patient year
Interval 8.13 to 12.3
|
|
Mean Outpatient Visits and Emergent Room Visits Per Patient Year
ER visits: Disease-specific
|
0.15 Visits per patient year
Interval 0.09 to 0.21
|
|
Mean Outpatient Visits and Emergent Room Visits Per Patient Year
ER visits: Other contacts
|
0.14 Visits per patient year
Interval 0.08 to 0.2
|
PRIMARY outcome
Timeframe: Up to maximum of 12 years (retrospective data collection of 1 month)Population: All eligible advanced/metastatic RCC participants who initiated treatment for mRCC were included.
The number of hospitalization visits per patient year for all contacts, disease-specific contacts and other contacts were reported in this outcome measure. All contacts included disease specific contacts and other contacts. Per patient year was defined as total sum of events divided by the total sum of follow-up length of the participants.
Outcome measures
| Measure |
All Participants With RCC
n=191 Participants
This study included participants diagnosed with RCC (local or metastatic) whose medical records were available at HDSF data lake irrespective of whether they received treatment. Participants were followed up from first record of RCC (index) until death, moved outside of HDSF or up to 31-Dec-2021.
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|---|---|
|
Mean Number of Hospitalizations Per Patient Year
All contacts
|
1.25 Hospitalizations per patient year
Interval 1.02 to 1.53
|
|
Mean Number of Hospitalizations Per Patient Year
Disease-specific
|
0.55 Hospitalizations per patient year
Interval 0.43 to 0.7
|
|
Mean Number of Hospitalizations Per Patient Year
Other contacts
|
0.7 Hospitalizations per patient year
Interval 0.56 to 0.87
|
PRIMARY outcome
Timeframe: Up to maximum of 12 years (retrospective data collection of 1 month)Population: All eligible advanced/metastatic RCC participants who initiated treatment for mRCC were included.
Number of procedures and surgeries per patient year were reported in this outcome measure. Per patient year was defined as total sum of events divided by the total sum of follow-up length of the participants.
Outcome measures
| Measure |
All Participants With RCC
n=191 Participants
This study included participants diagnosed with RCC (local or metastatic) whose medical records were available at HDSF data lake irrespective of whether they received treatment. Participants were followed up from first record of RCC (index) until death, moved outside of HDSF or up to 31-Dec-2021.
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|---|---|
|
Mean Number of Procedures and Surgeries Per Patient Year
Procedure: All contacts
|
10.82 Events per patient year
Interval 9.5 to 12.42
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|
Mean Number of Procedures and Surgeries Per Patient Year
Surgeries: All contacts
|
0.77 Events per patient year
Interval 0.58 to 0.98
|
PRIMARY outcome
Timeframe: From initiation of treatment until death, moved outside of HDSF or end of study (maximum up to 12 years)Population: All eligible advanced/metastatic RCC participants who initiated treatment for mRCC were included.
Number of participants receiving each treatment per treatment line were reported in this outcome measure.
Outcome measures
| Measure |
All Participants With RCC
n=191 Participants
This study included participants diagnosed with RCC (local or metastatic) whose medical records were available at HDSF data lake irrespective of whether they received treatment. Participants were followed up from first record of RCC (index) until death, moved outside of HDSF or up to 31-Dec-2021.
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|---|---|
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Number of Participants According to Treatment
1st line: Cabozantinib
|
25 Participants
|
|
Number of Participants According to Treatment
1st line: Ipilimumab, Nivolumab
|
8 Participants
|
|
Number of Participants According to Treatment
1st line: Other
|
5 Participants
|
|
Number of Participants According to Treatment
1st line: Pazopanib
|
24 Participants
|
|
Number of Participants According to Treatment
1st line: Sunitinib
|
129 Participants
|
|
Number of Participants According to Treatment
2nd line: Axitinib
|
21 Participants
|
|
Number of Participants According to Treatment
2nd line: Cabozantinib
|
24 Participants
|
|
Number of Participants According to Treatment
2nd line: Everolimus
|
15 Participants
|
|
Number of Participants According to Treatment
2nd line: Nivolumab
|
12 Participants
|
|
Number of Participants According to Treatment
2nd line: Other
|
0 Participants
|
|
Number of Participants According to Treatment
2nd line: Pazopanib
|
22 Participants
|
|
Number of Participants According to Treatment
2nd line: Sorafenib
|
9 Participants
|
|
Number of Participants According to Treatment
2nd line: Sunitinib
|
6 Participants
|
|
Number of Participants According to Treatment
3rd line: Axitinib
|
6 Participants
|
|
Number of Participants According to Treatment
3rd line: Cabozantinib
|
8 Participants
|
|
Number of Participants According to Treatment
3rd line: Everolimus
|
19 Participants
|
|
Number of Participants According to Treatment
3rd line: Nivolumab
|
5 Participants
|
|
Number of Participants According to Treatment
3rd line: Pazopanib
|
10 Participants
|
|
Number of Participants According to Treatment
3rd line: Sunitinib
|
7 Participants
|
PRIMARY outcome
Timeframe: Anytime between January 2010 to December 2017 (maximum up to 8 years)Population: All eligible advanced/metastatic RCC participants who initiated treatment for mRCC were included.
Number of participants according to treatment per treatment line between 2010 to 2017 were reported in this outcome measure.
Outcome measures
| Measure |
All Participants With RCC
n=191 Participants
This study included participants diagnosed with RCC (local or metastatic) whose medical records were available at HDSF data lake irrespective of whether they received treatment. Participants were followed up from first record of RCC (index) until death, moved outside of HDSF or up to 31-Dec-2021.
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|---|---|
|
Number of Participants According to Treatment Per Treatment Line Between 2010 to 2017
1st line: Other
|
0 Participants
|
|
Number of Participants According to Treatment Per Treatment Line Between 2010 to 2017
1st line: Pazopanib
|
19 Participants
|
|
Number of Participants According to Treatment Per Treatment Line Between 2010 to 2017
1st line: Sunitinib
|
86 Participants
|
|
Number of Participants According to Treatment Per Treatment Line Between 2010 to 2017
2nd line: Axitinib
|
18 Participants
|
|
Number of Participants According to Treatment Per Treatment Line Between 2010 to 2017
2nd line: Cabozantinib
|
5 Participants
|
|
Number of Participants According to Treatment Per Treatment Line Between 2010 to 2017
2nd line: Everolimus
|
12 Participants
|
|
Number of Participants According to Treatment Per Treatment Line Between 2010 to 2017
2nd line: Other
|
0 Participants
|
|
Number of Participants According to Treatment Per Treatment Line Between 2010 to 2017
2nd line: Pazopanib
|
18 Participants
|
|
Number of Participants According to Treatment Per Treatment Line Between 2010 to 2017
2nd line: Sorafenib
|
9 Participants
|
|
Number of Participants According to Treatment Per Treatment Line Between 2010 to 2017
3rd line: Axitinib
|
6 Participants
|
|
Number of Participants According to Treatment Per Treatment Line Between 2010 to 2017
3rd line: Everolimus
|
12 Participants
|
|
Number of Participants According to Treatment Per Treatment Line Between 2010 to 2017
3rd line: Other
|
5 Participants
|
|
Number of Participants According to Treatment Per Treatment Line Between 2010 to 2017
3rd line: Pazopanib
|
9 Participants
|
|
Number of Participants According to Treatment Per Treatment Line Between 2010 to 2017
3rd line: Sunitinib
|
5 Participants
|
PRIMARY outcome
Timeframe: Anytime between January 2018 to December 2021 (maximum up to 4 years)Population: All eligible advanced/metastatic RCC participants who initiated treatment for mRCC were included.
Number of participants according to treatment per treatment line between 2018 to 2021 were reported in this outcome measure.
Outcome measures
| Measure |
All Participants With RCC
n=191 Participants
This study included participants diagnosed with RCC (local or metastatic) whose medical records were available at HDSF data lake irrespective of whether they received treatment. Participants were followed up from first record of RCC (index) until death, moved outside of HDSF or up to 31-Dec-2021.
|
|---|---|
|
Number of Participants According to Treatment Per Treatment Line Between 2018 to 2021
1st line: Cabozantinib
|
25 Participants
|
|
Number of Participants According to Treatment Per Treatment Line Between 2018 to 2021
1st line: Ipilimumab, Nivolumab
|
8 Participants
|
|
Number of Participants According to Treatment Per Treatment Line Between 2018 to 2021
1st line: Other
|
0 Participants
|
|
Number of Participants According to Treatment Per Treatment Line Between 2018 to 2021
1st line: Pazopanib
|
5 Participants
|
|
Number of Participants According to Treatment Per Treatment Line Between 2018 to 2021
1st line: Sunitinib
|
43 Participants
|
|
Number of Participants According to Treatment Per Treatment Line Between 2018 to 2021
2nd line: Cabozantinib
|
19 Participants
|
|
Number of Participants According to Treatment Per Treatment Line Between 2018 to 2021
2nd line: Nivolumab
|
10 Participants
|
|
Number of Participants According to Treatment Per Treatment Line Between 2018 to 2021
2nd line: Other
|
16 Participants
|
|
Number of Participants According to Treatment Per Treatment Line Between 2018 to 2021
3rd line: Cabozantinib
|
5 Participants
|
|
Number of Participants According to Treatment Per Treatment Line Between 2018 to 2021
3rd line: Everolimus
|
7 Participants
|
|
Number of Participants According to Treatment Per Treatment Line Between 2018 to 2021
3rd line: Other
|
6 Participants
|
PRIMARY outcome
Timeframe: Up to maximum of 12 years (retrospective data collection of 1 month)Population: All eligible advanced/metastatic RCC participants who initiated treatment for mRCC were included.
Number of laboratory days per patient year were reported in this outcome measure. Per patient year was defined as total sum of events divided by the total sum of follow-up length of the participants.
Outcome measures
| Measure |
All Participants With RCC
n=191 Participants
This study included participants diagnosed with RCC (local or metastatic) whose medical records were available at HDSF data lake irrespective of whether they received treatment. Participants were followed up from first record of RCC (index) until death, moved outside of HDSF or up to 31-Dec-2021.
|
|---|---|
|
Mean Number of Laboratory Days Per Patient Year
|
21.85 Days per patient year
Interval 19.95 to 24.04
|
PRIMARY outcome
Timeframe: Up to maximum of 12 years (retrospective data collection of 1 month)Population: All eligible advanced/metastatic RCC participants who initiated treatment for mRCC were included. Here, 'Number Analyzed' signifies participants evaluable for the specified rows.
Number of laboratory days per patient year stratified by IMDC risk category were reported in this outcome measure. IMDC risk category included Score 0= favorable risk, no missing values allowed; Score 1-2= intermediate risk, total score=1: maximum 1 risk factor can have missing value, total score=2: no missing values allowed; Score 3-6= poor risk, maximum 3 risk factors allowed to have missing values; Unknown risk= when none of the above risk categories could be assigned. Per patient year was defined as total sum of events divided by the total sum of follow-up length of the participants.
Outcome measures
| Measure |
All Participants With RCC
n=191 Participants
This study included participants diagnosed with RCC (local or metastatic) whose medical records were available at HDSF data lake irrespective of whether they received treatment. Participants were followed up from first record of RCC (index) until death, moved outside of HDSF or up to 31-Dec-2021.
|
|---|---|
|
Mean Number of Laboratory Days Per Patient Year Stratified by International Metastatic Database Consortium (IMDC) Risk Category
IMDC 0
|
21.46 Days per patient year
Interval 18.22 to 25.05
|
|
Mean Number of Laboratory Days Per Patient Year Stratified by International Metastatic Database Consortium (IMDC) Risk Category
IMDC 1-2
|
20.26 Days per patient year
Interval 17.92 to 23.13
|
|
Mean Number of Laboratory Days Per Patient Year Stratified by International Metastatic Database Consortium (IMDC) Risk Category
IMDC 3+
|
28.26 Days per patient year
Interval 22.75 to 34.54
|
|
Mean Number of Laboratory Days Per Patient Year Stratified by International Metastatic Database Consortium (IMDC) Risk Category
IMDC Unknown
|
19.71 Days per patient year
Interval 16.22 to 26.77
|
PRIMARY outcome
Timeframe: At indexPopulation: All eligible advanced/metastatic RCC participants who initiated treatment for mRCC were included.
KPS:used for rating activities of daily living on 11-step scale from 0-100,higher score=participant better able to carry daily activities.Score: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 normal activity,60=required occasional assistance,able to care for personal needs,50=required considerable assistance \& frequent medical care,40=disabled;required special care/assistance,30=severely disabled;hospital admission indicated;20=very sick;hospital admission necessary,10=moribund \& 0=dead.IMDC risk category:0=favorable risk,no missing values allowed;1-2=intermediate risk,total score=1:max 1 risk factor could have missing value,total score=2:no missing values allowed;3-6=poor risk,max 3 risk factors allowed to have missing values; Unknown=none of the above risk categories could be assigned.Index date=date of treatment initiation for mRCC.
Outcome measures
| Measure |
All Participants With RCC
n=191 Participants
This study included participants diagnosed with RCC (local or metastatic) whose medical records were available at HDSF data lake irrespective of whether they received treatment. Participants were followed up from first record of RCC (index) until death, moved outside of HDSF or up to 31-Dec-2021.
|
|---|---|
|
Number of Participants Classified According to Karnofsky Performance Status (KPS) Stratified by IMDC Risk Category
KPS: 10-40; IMDC 0
|
0 Participants
|
|
Number of Participants Classified According to Karnofsky Performance Status (KPS) Stratified by IMDC Risk Category
KPS: 10-40; IMDC 1-2
|
0 Participants
|
|
Number of Participants Classified According to Karnofsky Performance Status (KPS) Stratified by IMDC Risk Category
KPS: 10-40; IMDC 3+
|
8 Participants
|
|
Number of Participants Classified According to Karnofsky Performance Status (KPS) Stratified by IMDC Risk Category
KPS: 10-40; IMDC unknown
|
0 Participants
|
|
Number of Participants Classified According to Karnofsky Performance Status (KPS) Stratified by IMDC Risk Category
KPS: 50-60; IMDC 0
|
0 Participants
|
|
Number of Participants Classified According to Karnofsky Performance Status (KPS) Stratified by IMDC Risk Category
KPS: 50-60; IMDC 1-2
|
17 Participants
|
|
Number of Participants Classified According to Karnofsky Performance Status (KPS) Stratified by IMDC Risk Category
KPS: 50-60; IMDC 3+
|
29 Participants
|
|
Number of Participants Classified According to Karnofsky Performance Status (KPS) Stratified by IMDC Risk Category
KPS: 50-60; IMDC unknown
|
5 Participants
|
|
Number of Participants Classified According to Karnofsky Performance Status (KPS) Stratified by IMDC Risk Category
KPS: 70-80; IMDC 0
|
10 Participants
|
|
Number of Participants Classified According to Karnofsky Performance Status (KPS) Stratified by IMDC Risk Category
KPS: 70-80; IMDC 1-2
|
48 Participants
|
|
Number of Participants Classified According to Karnofsky Performance Status (KPS) Stratified by IMDC Risk Category
KPS: 70-80; IMDC 3+
|
34 Participants
|
|
Number of Participants Classified According to Karnofsky Performance Status (KPS) Stratified by IMDC Risk Category
KPS: 70-80; IMDC unknown
|
10 Participants
|
|
Number of Participants Classified According to Karnofsky Performance Status (KPS) Stratified by IMDC Risk Category
KPS: 90-100; IMDC 0
|
0 Participants
|
|
Number of Participants Classified According to Karnofsky Performance Status (KPS) Stratified by IMDC Risk Category
KPS: 90-100; IMDC 1-2
|
10 Participants
|
|
Number of Participants Classified According to Karnofsky Performance Status (KPS) Stratified by IMDC Risk Category
KPS: 90-100; IMDC 3+
|
0 Participants
|
|
Number of Participants Classified According to Karnofsky Performance Status (KPS) Stratified by IMDC Risk Category
KPS: 90-100; IMDC unknown
|
0 Participants
|
|
Number of Participants Classified According to Karnofsky Performance Status (KPS) Stratified by IMDC Risk Category
Missing; IMDC 0
|
0 Participants
|
|
Number of Participants Classified According to Karnofsky Performance Status (KPS) Stratified by IMDC Risk Category
Missing; IMDC 1-2
|
0 Participants
|
|
Number of Participants Classified According to Karnofsky Performance Status (KPS) Stratified by IMDC Risk Category
Missing; IMDC 3+
|
0 Participants
|
|
Number of Participants Classified According to Karnofsky Performance Status (KPS) Stratified by IMDC Risk Category
Missing; IMDC unknown
|
0 Participants
|
PRIMARY outcome
Timeframe: At indexPopulation: All eligible participants were included. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Number of participants classified according to PAD were reported in this outcome measure. Histology included chromophobe renal cell carcinoma, clear cell renal cell carcinoma, oncocytoma renal cell carcinoma, papillary renal cell carcinoma, other (chromophobe, oncocytoma, and papillary renal cell carcinoma included if not reported separately) and missing. Index date was defined as the date of treatment initiation for mRCC.
Outcome measures
| Measure |
All Participants With RCC
n=1112 Participants
This study included participants diagnosed with RCC (local or metastatic) whose medical records were available at HDSF data lake irrespective of whether they received treatment. Participants were followed up from first record of RCC (index) until death, moved outside of HDSF or up to 31-Dec-2021.
|
|---|---|
|
Number of Participants Classified According to Pathological Diagnosis (PAD) Histology
RCC participants: Chromophobe renal cell carcinoma
|
41 Participants
|
|
Number of Participants Classified According to Pathological Diagnosis (PAD) Histology
RCC participants: Clear cell renal cell carcinoma
|
597 Participants
|
|
Number of Participants Classified According to Pathological Diagnosis (PAD) Histology
RCC participants: Oncocytoma renal cell carcinoma
|
27 Participants
|
|
Number of Participants Classified According to Pathological Diagnosis (PAD) Histology
RCC participants: Papillary renal cell carcinoma
|
105 Participants
|
|
Number of Participants Classified According to Pathological Diagnosis (PAD) Histology
RCC participants: Other
|
0 Participants
|
|
Number of Participants Classified According to Pathological Diagnosis (PAD) Histology
RCC participants: Missing
|
342 Participants
|
|
Number of Participants Classified According to Pathological Diagnosis (PAD) Histology
Treated mRCC participants: Chromophobe renal cell carcinoma
|
0 Participants
|
|
Number of Participants Classified According to Pathological Diagnosis (PAD) Histology
Treated mRCC participants: Clear cell renal cell carcinoma
|
115 Participants
|
|
Number of Participants Classified According to Pathological Diagnosis (PAD) Histology
Treated mRCC participants: Oncocytoma renal cell carcinoma
|
0 Participants
|
|
Number of Participants Classified According to Pathological Diagnosis (PAD) Histology
Treated mRCC participants: Papillary renal cell carcinoma
|
0 Participants
|
|
Number of Participants Classified According to Pathological Diagnosis (PAD) Histology
Treated mRCC participants: Other
|
11 Participants
|
|
Number of Participants Classified According to Pathological Diagnosis (PAD) Histology
Treated mRCC participants: Missing
|
65 Participants
|
|
Number of Participants Classified According to Pathological Diagnosis (PAD) Histology
Non-treated mRCC participants: Chromophobe renal cell carcinoma
|
0 Participants
|
|
Number of Participants Classified According to Pathological Diagnosis (PAD) Histology
Non-treated mRCC participants: Clear cell renal cell carcinoma
|
65 Participants
|
|
Number of Participants Classified According to Pathological Diagnosis (PAD) Histology
Non-treated mRCC participants: Oncocytoma renal cell carcinoma
|
0 Participants
|
|
Number of Participants Classified According to Pathological Diagnosis (PAD) Histology
Non-treated mRCC participants: Papillary renal cell carcinoma
|
0 Participants
|
|
Number of Participants Classified According to Pathological Diagnosis (PAD) Histology
Non-treated mRCC participants: Other
|
8 Participants
|
|
Number of Participants Classified According to Pathological Diagnosis (PAD) Histology
Non-treated mRCC participants: Missing
|
72 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From index until death due to any cause or end of study (maximum up to 12 years)Population: All eligible advanced/metastatic RCC participants who initiated treatment for mRCC were included. Here, 'Number Analyzed' signifies participants evaluable for the specified rows.
Overall Survival was defined as the time from index (start of each treatment line) until death due to any cause or end of study. Overall survival according to treatment lines (1, 2 or 3) was presented in this outcome measure.
Outcome measures
| Measure |
All Participants With RCC
n=191 Participants
This study included participants diagnosed with RCC (local or metastatic) whose medical records were available at HDSF data lake irrespective of whether they received treatment. Participants were followed up from first record of RCC (index) until death, moved outside of HDSF or up to 31-Dec-2021.
|
|---|---|
|
Overall Survival
Treatment line 1
|
21.4 Months
Interval 15.4 to 25.2
|
|
Overall Survival
Treatment line 2
|
14.9 Months
Interval 9.6 to 19.6
|
|
Overall Survival
Treatment line 3
|
13.8 Months
Interval 8.7 to 21.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From start of current treatment to date of next line treatment or death or end of study (maximum up to 12 years)Population: All eligible advanced/metastatic RCC participants who initiated treatment for mRCC were included. Here, 'Number Analyzed' signifies participants evaluable for the specified rows.
Time to next treatment (TTNT) was defined as the interval between the start of current treatment and the start of the next-line treatment or death or end of study. Kaplan-Meier method was used for analysis. TTNT according to treatment lines were presented in this outcome measure.
Outcome measures
| Measure |
All Participants With RCC
n=191 Participants
This study included participants diagnosed with RCC (local or metastatic) whose medical records were available at HDSF data lake irrespective of whether they received treatment. Participants were followed up from first record of RCC (index) until death, moved outside of HDSF or up to 31-Dec-2021.
|
|---|---|
|
Time to Next Treatment (TTNT)
Treatment line 1
|
9.3 Months
Interval 7.5 to 11.1
|
|
Time to Next Treatment (TTNT)
Treatment line 2
|
7.7 Months
Interval 3.9 to 12.3
|
|
Time to Next Treatment (TTNT)
Treatment line 3
|
7.3 Months
Interval 5.1 to 8.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At indexPopulation: All eligible advanced/metastatic RCC participants who initiated treatment for mRCC were included.
Number of participants classified according to IMDC risk group status at initiation of treatment were reported in this outcome measure. IMDC risk category included score 0= favorable risk, no missing values allowed; score 1-2= Intermediate risk, total score=1: maximum 1 risk factor can have missing value, total score=2: no missing values allowed; Score 3-6= Poor risk, maximum 3 risk factors allowed to have missing values; Unknown risk= when none of the above risk categories could be assigned. Index date was defined as the date of treatment initiation for mRCC.
Outcome measures
| Measure |
All Participants With RCC
n=191 Participants
This study included participants diagnosed with RCC (local or metastatic) whose medical records were available at HDSF data lake irrespective of whether they received treatment. Participants were followed up from first record of RCC (index) until death, moved outside of HDSF or up to 31-Dec-2021.
|
|---|---|
|
Number of Participants Classified According to IMDC Risk Group Status at Initiation of Treatment
IMDC 0
|
15 Participants
|
|
Number of Participants Classified According to IMDC Risk Group Status at Initiation of Treatment
IMDC 1-2
|
81 Participants
|
|
Number of Participants Classified According to IMDC Risk Group Status at Initiation of Treatment
IMDC 3+
|
74 Participants
|
|
Number of Participants Classified According to IMDC Risk Group Status at Initiation of Treatment
IMDC Unknown
|
21 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to maximum of 12 years (retrospective data collection of 1 month)Population: All eligible advanced/metastatic RCC participants who initiated treatment for mRCC were included.
Absolute costs associated with healthcare resource utilization for all contacts, disease-specific contacts and other contacts was reported in this outcome measure. All contacts included ER visits, hospitalizations, and outpatient contacts.
Outcome measures
| Measure |
All Participants With RCC
n=191 Participants
This study included participants diagnosed with RCC (local or metastatic) whose medical records were available at HDSF data lake irrespective of whether they received treatment. Participants were followed up from first record of RCC (index) until death, moved outside of HDSF or up to 31-Dec-2021.
|
|---|---|
|
Mean Absolute Costs Associated With Healthcare Resource Utilization
All contacts
|
15,473.75 Euros per patient year
|
|
Mean Absolute Costs Associated With Healthcare Resource Utilization
Disease-specific contacts
|
9,114.95 Euros per patient year
|
|
Mean Absolute Costs Associated With Healthcare Resource Utilization
Other contacts
|
6,358.79 Euros per patient year
|
Adverse Events
Treated mRCC Participants
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