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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-003416-23 | EudraCT Number |
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Patients with metastatic renal cell carcinoma (mRCC) who failed first-line therapy with sunitinib or pazopanib was treated with everolimus. Efficacy and safety of everolimus was evaluated in these patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Everolimus | Experimental | Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Everolimus (RAD001) | Drug | Everolimus was used as commercially available formulated tablets of 10 mg strength |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Progression-free Patients by Month 6 | Percentage of progression-free patients by month 6 after starting everolimus treatment. For the purpose of the binomial design of the study, a patient being 'progression-free' will be defined as a patient without disease progression by month 6 whereas a subject with progressive disease by month 6 will not be counted as 'progression-free'. The primary variable was derived from radiologic tumor assessments according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1.) Disease progression was either 1) a 20% increase in the sum of the longest diameter of all target lesions, taking as reference the smallest sum of the longest diameters of all target lesions recorded at or after baseline (minimum absolute increase 5 mm in sum) or 2) the appearance of a new lesion or 3) the unequivocal progression of non-target lesions overall. | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Overall Response Rate (ORR) Treated With Everolimus After Failure of First-line Sunitinib or Pazopanib Therapy at Month 6 | Overall response rate (ORR) is the Percentage of patients with a best overall response of complete response (CR) or partial response (PR) by month 6. ORR was assessed according to RECIST 1.1 criteria. Partial response (PR) required at least a 30% decrease in the sum of the longest diameters of all target lesions, taking as reference the baseline sum of the longest diameters. Complete response (CR) required a disappearance of all target and non-target lesions. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Chemnitz | 09130 | Germany | |||
| Novartis Investigative Site |
Single arm study of everolimus broken down into 2 subgroups for analyses and safety based on failed 1st line therapy (sunitinib or pazopanib) prior to starting study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 1st Line SUN | Patients that failed 1st line therapy Sunitinib (SUN) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent. |
| FG001 | 1st Line PAZ |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Month 6 |
| Progression-Free Survival (PFS) as the Time Interval Between First Intake of Everolimus and First Documented Disease Progression or Death Due to Any Cause at 24 Months | Progression-free survival (PFS) is the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient did not have an event, progression-free survival was censored at the date of last adequate tumor assessment | 24 months |
| Overall Survival (OS) of Patients Treated With Everolimus After Failure of First-line Sunitinib or Pazopanib Therapy up to 48 Months | Overall survival (OS) was defined as the time from date of start of treatment to date of death due to any cause. If a patient was not known to have died, survival will be censored at the date of last contact. | 48 months |
| Duration of Response (DOR) in Patients Treated With Everolimus After Failure of First-line Sunitinib or Pazopanib Therapy up to 48 Months | The duration of overall response (DOR) was defined as the time from the first occurrence of a confirmed Complete Response (CR) or Partial Response (PR) (as per investigator assessment according to RECIST 1.1) until the date of the first documented disease progression or death due to underlying cancer. If a patient did not have an event or received any further anticancer therapy, duration of overall response was censored at the date of last adequate tumor assessment. Duration of response was displayed only for patients whose best overall response was CR or PR. As none of the patients showed any response (CR or PR), DOR could not be calculated | 48 months |
| Dresden |
| 01307 |
| Germany |
| Novartis Investigative Site | Hanover | 30559 | Germany |
| Novartis Investigative Site | Hof | 95028 | Germany |
| Novartis Investigative Site | Kassel | 34125 | Germany |
| Novartis Investigative Site | Langen | 63225 | Germany |
| Novartis Investigative Site | Leipzig | 04357 | Germany |
| Novartis Investigative Site | Magdeburg | 39120 | Germany |
| Novartis Investigative Site | Münster | 48149 | Germany |
| Novartis Investigative Site | Ravensburg | 88214 | Germany |
| Novartis Investigative Site | Velbert | 42551 | Germany |
| Novartis Investigative Site | Wiesbaden | 65191 | Germany |
| Novartis Investigative Site | Wolfsburg | 38440 | Germany |
Patients that failed 1st line therapy Pazopanib (PAZ) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent. |
| Full Analysis Set (FAS) |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Demographic and other baseline data (including disease characteristics) were summarized descriptively for all patients for the FAS. The full analysis set (FAS) consisted of all patients who received at least one dose of everolimus.
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| ID | Title | Description |
|---|---|---|
| BG000 | 1st Line SUN | Patients that failed 1st line therapy Sunitinib (SUN) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent. |
| BG001 | 1st Line PAZ | Patients that failed 1st line therapy Pazopanib (PAZ) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent. |
| 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 |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Percentage of Progression-free Patients by Month 6 | Percentage of progression-free patients by month 6 after starting everolimus treatment. For the purpose of the binomial design of the study, a patient being 'progression-free' will be defined as a patient without disease progression by month 6 whereas a subject with progressive disease by month 6 will not be counted as 'progression-free'. The primary variable was derived from radiologic tumor assessments according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1.) Disease progression was either 1) a 20% increase in the sum of the longest diameter of all target lesions, taking as reference the smallest sum of the longest diameters of all target lesions recorded at or after baseline (minimum absolute increase 5 mm in sum) or 2) the appearance of a new lesion or 3) the unequivocal progression of non-target lesions overall. | Full Analysis Set (FAS) consisted of all patients who received at least one dose of everolimus. | Posted | Number | Percentage of participants | Month 6 |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With Overall Response Rate (ORR) Treated With Everolimus After Failure of First-line Sunitinib or Pazopanib Therapy at Month 6 | Overall response rate (ORR) is the Percentage of patients with a best overall response of complete response (CR) or partial response (PR) by month 6. ORR was assessed according to RECIST 1.1 criteria. Partial response (PR) required at least a 30% decrease in the sum of the longest diameters of all target lesions, taking as reference the baseline sum of the longest diameters. Complete response (CR) required a disappearance of all target and non-target lesions. | Full Analysis Set (FAS) consisted of all patients who received at least one dose of everolimus. | Posted | Number | percentage of participants | Month 6 |
| |||||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) as the Time Interval Between First Intake of Everolimus and First Documented Disease Progression or Death Due to Any Cause at 24 Months | Progression-free survival (PFS) is the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient did not have an event, progression-free survival was censored at the date of last adequate tumor assessment | Full Analysis Set (FAS) consisted of all patients who received at least one dose of everolimus. | Posted | Median | 80% Confidence Interval | months | 24 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) of Patients Treated With Everolimus After Failure of First-line Sunitinib or Pazopanib Therapy up to 48 Months | Overall survival (OS) was defined as the time from date of start of treatment to date of death due to any cause. If a patient was not known to have died, survival will be censored at the date of last contact. | Full Analysis Set (FAS) consisted of all patients who received at least one dose of everolimus. | Posted | Median | 80% Confidence Interval | months | 48 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) in Patients Treated With Everolimus After Failure of First-line Sunitinib or Pazopanib Therapy up to 48 Months | The duration of overall response (DOR) was defined as the time from the first occurrence of a confirmed Complete Response (CR) or Partial Response (PR) (as per investigator assessment according to RECIST 1.1) until the date of the first documented disease progression or death due to underlying cancer. If a patient did not have an event or received any further anticancer therapy, duration of overall response was censored at the date of last adequate tumor assessment. Duration of response was displayed only for patients whose best overall response was CR or PR. As none of the patients showed any response (CR or PR), DOR could not be calculated | Duration of response was displayed only for patients whose best overall response was CR or PR. As none of the patients showed any response (CR or PR), DOR could not be calculated | Posted | 48 months |
|
Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
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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 | 1st Line SUN | Patients that failed 1st line therapy Sunitinib (SUN) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent. | 6 | 16 | 15 | 16 | ||
| EG001 | 1st Line PAZ | Patients that failed 1st line therapy Pazopanib (PAZ) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent. | 8 | 13 | 13 | 13 | ||
| EG002 | Everolimus All Patients | Everolimus - All Patients that failed 1st line SUN and 1st Line PAZ and was on Everolimus 10mg orally once daily | 14 | 29 | 28 | 29 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| ATRIOVENTRICULAR BLOCK COMPLETE | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| PERICARDIAL EFFUSION | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| ENTEROCUTANEOUS FISTULA | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| ABDOMINAL ABSCESS | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| ENDOCARDITIS | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| GASTROINTESTINAL INFECTION | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| HYPOALBUMINAEMIA | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| FLANK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| MALIGNANT NEOPLASM PROGRESSION | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| DEMENTIA | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| POLYURIA | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| RENAL FAILURE | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| HAEMORRHAGIC DIATHESIS | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| CARDIAC FAILURE | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| RIGHT VENTRICULAR FAILURE | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| TACHYCARDIA | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| EYELID OEDEMA | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| ABDOMINAL PAIN LOWER | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| APHTHOUS ULCER | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| ASCITES | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| DRY MOUTH | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| DYSPHAGIA | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| FLATULENCE | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| LIP ULCERATION | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| ORAL DISCOMFORT | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| ORAL PAIN | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| SALIVARY HYPERSECRETION | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| CHILLS | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| FACE OEDEMA | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| FEELING COLD | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| CANDIDA INFECTION | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| CONJUNCTIVITIS | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| PERITONITIS | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| PHARYNGITIS | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| RHINITIS | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| URINARY TRACT INFECTION STAPHYLOCOCCAL | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| BLOOD ALKALINE PHOSPHATASE INCREASED | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| BLOOD CHLORIDE DECREASED | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| BLOOD CHLORIDE INCREASED | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| BLOOD LACTATE DEHYDROGENASE INCREASED | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| BLOOD PHOSPHORUS DECREASED | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| CLOSTRIDIUM TEST POSITIVE | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| GLUCOSE URINE PRESENT | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| HAEMATOCRIT DECREASED | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| HIGH DENSITY LIPOPROTEIN DECREASED | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| LOW DENSITY LIPOPROTEIN INCREASED | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| NEUTROPHIL COUNT INCREASED | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| PLATELET COUNT INCREASED | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| RED BLOOD CELL COUNT DECREASED | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| CACHEXIA | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| HYPERTRIGLYCERIDAEMIA | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| HYPERURICAEMIA | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| HYPOALBUMINAEMIA | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| HYPOCALCAEMIA | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| HYPOCHLORAEMIA | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| HYPOPHOSPHATAEMIA | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| PROTEIN DEFICIENCY | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| FLANK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| GROIN PAIN | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| JOINT EFFUSION | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| OSTEOCHONDROSIS | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| OSTEONECROSIS OF JAW | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| TUMOUR PAIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| AGEUSIA | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| DYSGEUSIA | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| HYPOAESTHESIA | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| HYPOGEUSIA | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| NEURALGIA | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| ORTHOSTATIC INTOLERANCE | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| POLYNEUROPATHY | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| TREMOR | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| APATHY | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| RESTLESSNESS | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| SLEEP DISORDER | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| INCONTINENCE | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| NEPHROSCLEROSIS | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| PROTEINURIA | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| RENAL FAILURE | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| GENITAL TRACT INFLAMMATION | Reproductive system and breast disorders | MedDRA (18.0) | Systematic Assessment |
| |
| PELVIC PAIN | Reproductive system and breast disorders | MedDRA (18.0) | Systematic Assessment |
| |
| ALVEOLITIS | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| DYSPNOEA AT REST | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| NASAL INFLAMMATION | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| PAINFUL RESPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| PULMONARY FIBROSIS | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| TACHYPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| DECUBITUS ULCER | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| ECZEMA | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| ONYCHOCLASIS | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| BLOOD PRESSURE FLUCTUATION | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
| |
| PERIPHERAL COLDNESS | Vascular disorders | MedDRA (18.0) | 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 (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
| 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 |
|---|---|
| D000068338 | Everolimus |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Male |
|
| Units | Counts |
|---|---|
| Participants |
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| Counts |
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| Participants |
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