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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-000708-10 | EudraCT Number |
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The main purpose of this study was to assess the progression-free survival (PFS) based on local investigator assessment of pazopanib in participants with advanced and/or metastatic renal cell carcinoma (mRCC) following prior treatment with immune checkpoint inhibitors (ICI).
This was a multi-center, open-label, single-arm Phase II study to determine the efficacy, tolerability, safety and quality of life of treatment with pazopanib in subjects with advanced and/or metastatic renal cell carcinoma (RCC) following prior treatment with immune checkpoint inhibitors (ICI).
Subjects could have received prior systemic therapy with an ICI (monotherapy or combination) as 1st or 2nd line RCC treatment. However, they must not have received pazopanib previously. In this study, pazopanib could be administered in the 2nd or 3rd line setting. The therapeutic line for individual subjects was assigned at the time of screening.
Subjects received 800 mg of pazopanib daily until disease progression, unacceptable toxicity, death, pregnancy, start of a new anti-neoplastic therapy, discontinuation at the discretion of the investigator or patient, lost to follow-up or end of study, whichever came first.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pazopanib- 2nd line treatment | Experimental | Participants received pazopanib as 2nd line treatment |
|
| Pazopanib- 3rd line treatment | Experimental | Participants received pazopanib as 3rd line treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pazopanib | Drug | Participants received 800mg of pazopanib once daily orally. Pazopanib was supplied as aqueous film-coated tablets containing 200 mg or 400 mg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | PFS is defined as the time from the start date of pazopanib treatment to the date of the first documented progression or death due to any cause. PFS was assessed via local review according to RECIST 1.1. PFS was censored at the date of the last adequate tumor assessment if no PFS event (disease progression or death due to any cause) was observed prior to the analysis cut-off date. The PFS distribution was estimated using the Kaplan-Meier method. | Date of first treatment to date of progression or death up to approximately 38 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) Based on Local Investigator Assessment According to RECIST v1.1 | ORR is defined as the percentage of participants with best overall response of confirmed complete response (CR) or partial response (PR) based on local investigator's assessment according to RECIST v1.1. The 95% confidence intervals (CIs) were computed using Clopper and Pearson method. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| A Plain Language Trial Summary is available on novctrd.com | View source |
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Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.
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A total of 87 participants were screened of which 62 participants were enrolled in the this study to receive study treatment.
The study was conducted across 22 centers in 11 countries
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| ID | Title | Description |
|---|---|---|
| FG000 | Pazopanib- 2nd Line | Participants received pazopanib as 2nd line treatment |
| FG001 | Pazopanib- 3rd Line | Participants received pazopanib as 3rd line treatment |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 14, 2020 | Jul 15, 2022 |
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| Up to approximately 38 months |
| Clinical Benefit Rate (CBR) Based on Local Investigator Assessment According to RECIST v1.1. | CBR is defined as the percentage of participants with a best overall response of CR or PR or an overall lesion response of stable disease (SD) or Non-CR/Non-PD lasting ≥ 24 weeks based on local investigator's assessment according to RECIST v1.1. The 95% confidence intervals (CIs) were computed using Clopper and Pearson method. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease. | Up to approximately 38 months |
| Overall Survival (OS) | OS is defined as the time from the first administration of study treatment until death due to any cause. If a participant was not known to have died, survival was censored at the date of last known date patient alive. The OS distribution was estimated using the Kaplan-Meier method. | From date of first treatment to date of death, up to approximately 44 months |
| Duration of Response (DOR) Based on Local Investigators Assessment According to RECIST v1.1 | DOR is defined as the time from the date of first documented response (confirmed CR or PR according to RECIST v1.1 based on local Investigators review of tumor assessment data) to the date of tumor progression, or death due to underlying cancer, whichever comes first. If a patient not had an event, duration was censored at the date of last adequate tumor assessment. The DOR distribution was calculated using the Kaplan-Meier method. | From the date of first documented response (confirmed CR or PR) to the date of tumor progression, up to approximately 36 months |
| Change From Baseline in Functional Assessment of Cancer Therapy- Kidney Symptom (FKSI-DRS) Score | FKSI-DRS is a 9-item questionnaire specifically designed to evaluate symptoms that are directly attributable to kidney cancer and includes patient's symptoms in the past seven days such as lack of energy, pain, bone-pain, shortness of breath, fatigue, blood in urine, etc. Each item is scored on a 5-point scale (0=not at all to 4=very much). FKSI-DRS total score ranged from 0 (no symptoms) to 36 (most severe symptoms) with a higher score indicating greater presence of kidney cancer symptoms. The baseline is defined as the last FKSI-DRS assessment on or prior to first day of treatment. A negative change from baseline indicates improvement in kidney cancer symptom status. | Baseline, Day 1 of Cycle 2, 3, 4, 5, 6, 7, 9, 11, 13, 16 and every 3rd cycle thereafter until end of treatment, and end of treatment, assessed up to approximately 38 months. Cycle=28 days |
| Change From Baseline in EuroQoL 5-level Instrument Visual Analogue Scale (EQ-5L-5D VAS) Score | EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). The EQ-5L-5D VAS records the respondent's self-rated health on a vertical VAS, ranging from 0 (worst imaginable health state) to 100 (best imaginable health state), with higher scores indicating higher health-related quality of life. The baseline is defined as the last EQ-5L-5D assessment on or prior to first day of treatment. A positive change from baseline indicates improvement in the heath state. | Baseline, Day 1 of Cycle 2, 3, 4, 5, 6, 7, 9, 11, 13, 16 and every 3rd cycle thereafter until end of treatment, and end of treatment, assessed up to approximately 38 months. Cycle=28 days |
| Caba |
| Buenos Aires |
| C1280AEB |
| Argentina |
| Novartis Investigative Site | Graz | 8036 | Austria |
| Novartis Investigative Site | Salzburg | 5020 | Austria |
| Novartis Investigative Site | Vienna | A-1090 | Austria |
| Novartis Investigative Site | Calgary | Alberta | T2N 4N2 | Canada |
| Novartis Investigative Site | Temuco | Araucania | 4810469 | Chile |
| Novartis Investigative Site | Santiago | 8420383 | Chile |
| Novartis Investigative Site | Brno | Czech Republic | 656 53 | Czechia |
| Novartis Investigative Site | Olomouc | CZE | 775 20 | Czechia |
| Novartis Investigative Site | Paris | 75015 | France |
| Novartis Investigative Site | Strasbourg | F 67098 | France |
| Novartis Investigative Site | Valenciennes | 59300 | France |
| Novartis Investigative Site | Hanover | 30625 | Germany |
| Novartis Investigative Site | Jena | 07740 | Germany |
| Novartis Investigative Site | Tübingen | 72076 | Germany |
| Novartis Investigative Site | Budapest | H 1122 | Hungary |
| Novartis Investigative Site | Seville | Andalusia | 41013 | Spain |
| Novartis Investigative Site | Madrid | 28041 | Spain |
| Novartis Investigative Site | London | NW3 2QG | United Kingdom |
| Novartis Investigative Site | Manchester | M20 2BX | United Kingdom |
| Novartis Investigative Site | Preston | PR2 9HT | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pazopanib- 2nd Line | Participants received pazopanib as 2nd line treatment |
| BG001 | Pazopanib- 3rd Line | Participants received pazopanib as 3rd line treatment |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression Free Survival (PFS) | PFS is defined as the time from the start date of pazopanib treatment to the date of the first documented progression or death due to any cause. PFS was assessed via local review according to RECIST 1.1. PFS was censored at the date of the last adequate tumor assessment if no PFS event (disease progression or death due to any cause) was observed prior to the analysis cut-off date. The PFS distribution was estimated using the Kaplan-Meier method. | Full Analysis Set (FAS): all subjects to whom study treatment has been assigned and who received at least one dose of pazopanib. | Posted | Median | 95% Confidence Interval | Months | Date of first treatment to date of progression or death up to approximately 38 months |
|
|
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| Secondary | Overall Response Rate (ORR) Based on Local Investigator Assessment According to RECIST v1.1 | ORR is defined as the percentage of participants with best overall response of confirmed complete response (CR) or partial response (PR) based on local investigator's assessment according to RECIST v1.1. The 95% confidence intervals (CIs) were computed using Clopper and Pearson method. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. | Full Analysis Set (FAS): All participants to whom study treatment was assigned and who received at least one dose of pazopanib. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to approximately 38 months |
| |||||||||||||||||||||||||||||||||
| Secondary | Clinical Benefit Rate (CBR) Based on Local Investigator Assessment According to RECIST v1.1. | CBR is defined as the percentage of participants with a best overall response of CR or PR or an overall lesion response of stable disease (SD) or Non-CR/Non-PD lasting ≥ 24 weeks based on local investigator's assessment according to RECIST v1.1. The 95% confidence intervals (CIs) were computed using Clopper and Pearson method. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease. | Full Analysis Set (FAS): All participants to whom study treatment was assigned and who received at least one dose of pazopanib. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to approximately 38 months |
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| Secondary | Overall Survival (OS) | OS is defined as the time from the first administration of study treatment until death due to any cause. If a participant was not known to have died, survival was censored at the date of last known date patient alive. The OS distribution was estimated using the Kaplan-Meier method. | Full Analysis Set (FAS): All participants to whom study treatment was assigned and who received at least one dose of pazopanib | Posted | Median | 95% Confidence Interval | Months | From date of first treatment to date of death, up to approximately 44 months |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) Based on Local Investigators Assessment According to RECIST v1.1 | DOR is defined as the time from the date of first documented response (confirmed CR or PR according to RECIST v1.1 based on local Investigators review of tumor assessment data) to the date of tumor progression, or death due to underlying cancer, whichever comes first. If a patient not had an event, duration was censored at the date of last adequate tumor assessment. The DOR distribution was calculated using the Kaplan-Meier method. | Participants in the Full Analysis Set (FAS) for whom best overall response is complete response (CR) or partial response (PR) | Posted | Median | 95% Confidence Interval | Months | From the date of first documented response (confirmed CR or PR) to the date of tumor progression, up to approximately 36 months |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Functional Assessment of Cancer Therapy- Kidney Symptom (FKSI-DRS) Score | FKSI-DRS is a 9-item questionnaire specifically designed to evaluate symptoms that are directly attributable to kidney cancer and includes patient's symptoms in the past seven days such as lack of energy, pain, bone-pain, shortness of breath, fatigue, blood in urine, etc. Each item is scored on a 5-point scale (0=not at all to 4=very much). FKSI-DRS total score ranged from 0 (no symptoms) to 36 (most severe symptoms) with a higher score indicating greater presence of kidney cancer symptoms. The baseline is defined as the last FKSI-DRS assessment on or prior to first day of treatment. A negative change from baseline indicates improvement in kidney cancer symptom status. | Full Analysis Set (FAS): All participants to whom study treatment was assigned and who received at least one dose of pazopanib. Number analyzed indicates participants with data available for analyses at the given timepoint. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Day 1 of Cycle 2, 3, 4, 5, 6, 7, 9, 11, 13, 16 and every 3rd cycle thereafter until end of treatment, and end of treatment, assessed up to approximately 38 months. Cycle=28 days |
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| Secondary | Change From Baseline in EuroQoL 5-level Instrument Visual Analogue Scale (EQ-5L-5D VAS) Score | EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). The EQ-5L-5D VAS records the respondent's self-rated health on a vertical VAS, ranging from 0 (worst imaginable health state) to 100 (best imaginable health state), with higher scores indicating higher health-related quality of life. The baseline is defined as the last EQ-5L-5D assessment on or prior to first day of treatment. A positive change from baseline indicates improvement in the heath state. | Full Analysis Set (FAS): All participants to whom study treatment was assigned and who received at least one dose of pazopanib. Number analyzed indicates participants with data available for analyses at the given timepoint. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Day 1 of Cycle 2, 3, 4, 5, 6, 7, 9, 11, 13, 16 and every 3rd cycle thereafter until end of treatment, and end of treatment, assessed up to approximately 38 months. Cycle=28 days |
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| Post-Hoc | All Collected Deaths | On-treatment deaths were collected from first dose of study medication to 30 days after the last dose of study medication, for a maximum duration of approximately 38 months. Post-treatment survival follow-up deaths were collected from day 31 after last dose of study medication to end of study, up to approximately 44 months. All deaths refer to the sum of on-treatment deaths and post-treatment survival follow-up deaths. | Participants who received at least one dose of pazopanib | Posted | Count of Participants | Participants | On-treatment deaths: Up to approximately 38 months. Post-treatment survival follow-up deaths: Up to approximately 44 months |
|
Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pazopanib- 2nd Line (On-Treatment) | AEs during on-treatment period (up to 30 days post-treatment) | 5 | 47 | 21 | 47 | 46 | 47 |
| EG001 | Pazopanib- 3rd Line (On-Treatment) | AEs collected during on-treatment period (up to 30 days post- treatment) | 1 | 15 | 9 | 15 | 14 | 15 |
| EG002 | Pazopanib- 2nd Line (Post-treatment Survival Follow-up) | Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period | 22 | 35 | 0 | 0 | 0 | 0 |
| EG003 | Pazopanib- 3rd Line (Post-treatment Survival Follow-up) | Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period | 10 | 13 | 0 | 0 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (24.0) | Systematic Assessment |
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| Drug-induced liver injury | Hepatobiliary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Immune system disorder | Immune system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Bronchitis viral | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Meningitis bacterial | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Wound haemorrhage | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hydrothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pemphigoid | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Vasculitis | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Serum ferritin increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Troponin T increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pharyngeal erythema | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study director | Novartis Pharmaceuticals | +1 862-778-8300 | novartis.email@novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 11, 2020 | Jul 15, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C516667 | pazopanib |
Not provided
Not provided
Not provided
| Male |
|
| Asian |
|
| Other |
|
| Unknown |
|
|
|
All participants who received pazopanib as 2nd or 3rd line treatment |
|
|
|
|
|
| OG002 | All Participants | All participants who received pazopanib as 2nd or 3rd line treatment |
|
|
| OG002 | All Participants | All participants who received pazopanib as 2nd or 3rd line treatment |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|