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This is a non-interventional, multicenter study to evaluate efficacy and safety of intravenous bevacizumab (Avastin) in combination with interferon alpha-2a immunotherapy for first-line treatment in participants with advanced and/or metastatic renal cell cancer (mRCC) in daily routine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Advanced and/or Metastatic RCC participants | Participants with mRCC who are being treated with bevacizumab at the recommended dose of 10 milligram per kilogram (mg/kg) of body weight once every 2 weeks as an intravenous infusion, in combination with interferon alpha-2a at the recommended starting dose of 9 million international units (MIU) 3 times a week until disease progression will be observed. No diagnostic or therapeutic interventions will be given other than used in normal daily routine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab will be administered at the recommended dose of 10 mg/kg of body weight once every 2 weeks as an intravenous infusion until disease progression. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Best Overall Tumor Response | Tumor response was assessed as one of the following: Complete response (CR): disappearance of all target lesions and all pathological lymph nodes below 10 millimeter (mm). Partial response (PR): At least a 30 percent (%) decrease in the sum of diameters of target lesions. Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions. | Baseline until progression or intolerable toxicity, whichever occurred first, assessed up to 6 years |
| Percentage of Participants With Disease Control | Disease control was defined as having achieved CR, PR, and/or SD during the course of the observation. CR: disappearance of all target lesions and all pathological lymph nodes below 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions. | Baseline until progression or intolerable toxicity, whichever occurred first, assessed up to 6 years |
| Progression-free Survival (PFS) Time | PFS time is defined as time between start of therapy and progression or death. Kaplan-Meier estimate was used for evaluation. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions. | Baseline until progression or intolerable toxicity or death, whichever occurred first, assessed up to 6 years |
| Overall Survival (OS) Time | OS time is defined as time between start of therapy and date of death. Kaplan-Meier estimate was used for evaluation. |
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Inclusion Criteria:
Exclusion Criteria:
-
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Participants with advanced and/or metastatic renal cell cancer
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Freiburg im Breisgau | 79106 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30711970 | Derived | Schultze-Seemann W, Schulz H, Tschechne B, Hackl M. Bevacizumab plus IFN-alpha-2a in First-line Treatment of Patients With Advanced or Metastatic Renal Cell Carcinoma: A Prospective German Non-interventional Study. Anticancer Res. 2019 Feb;39(2):875-882. doi: 10.21873/anticanres.13188. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Advanced and/or Metastatic RCC Participants | Participants with metastatic renal cell cancer (mRCC) who were treated with bevacizumab at the recommended dose of 10 milligram per kilogram (mg/kg) of body weight once every 2 weeks as an intravenous infusion, in combination with interferon alpha-2a at the recommended starting dose of 9 million international units (MIU) 3 times a week until disease progression were observed. No diagnostic or therapeutic interventions were given other than used in normal daily routine. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety set included all participants who have received at least once one dose of bevacizumab.
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| ID | Title | Description |
|---|---|---|
| BG000 | Advanced and/or Metastatic RCC Participants | Participants with metastatic renal cell cancer (mRCC) who were treated with bevacizumab at the recommended dose of 10 milligram per kilogram (mg/kg) of body weight once every 2 weeks as an intravenous infusion, in combination with interferon alpha-2a at the recommended starting dose of 9 million international units (MIU) 3 times a week until disease progression were observed. No diagnostic or therapeutic interventions were given other than used in normal daily routine. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Participants With Best Overall Tumor Response | Tumor response was assessed as one of the following: Complete response (CR): disappearance of all target lesions and all pathological lymph nodes below 10 millimeter (mm). Partial response (PR): At least a 30 percent (%) decrease in the sum of diameters of target lesions. Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions. | Full analysis set (FAS) included all participants who received at least one dose of study medication and have at least one post dose efficacy assessment, following the intention-to-treat principle. 'Number of participants analyzed' indicate participants with non-missing tumor response data. | Posted | Number | percentage of participants | Baseline until progression or intolerable toxicity, whichever occurred first, assessed up to 6 years |
|
Baseline up to 6 years
Safety set
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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 | Advanced and/or Metastatic RCC Participants | Participants with metastatic renal cell cancer (mRCC) who were treated with bevacizumab at the recommended dose of 10 milligram per kilogram (mg/kg) of body weight once every 2 weeks as an intravenous infusion, in combination with interferon alpha-2a at the recommended starting dose of 9 million international units (MIU) 3 times a week until disease progression were observed. No diagnostic or therapeutic interventions were given other than used in normal daily routine. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebral haemorrhage | Nervous system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-LaRoche | 800-821-8590 | genentech@druginfo.com |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D000077190 | Interferon alpha-2 |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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Not provided
|
| Interferon alpha-2a | Drug | Interferon alpha-2a will be administered at the recommended starting dose of 9 MIU 3 times a week until disease progression. |
|
| Baseline until progression or intolerable toxicity or death, whichever occurred first, assessed up to 6 years |
| Cumulative Dose of Immunotherapy (Interferon Alpha-2a) in Daily Routine | Up to 52 weeks |
| Death from other cause |
|
| Refusal of treatment / poor cooperation |
|
| Administrative reasons |
|
| Lost to Follow-up |
|
| Enrolled, not treated |
|
| Other |
|
| years |
|
| Sex/Gender, Customized | Number | participants |
|
| OG000 | Advanced and/or Metastatic RCC Participants | Participants with metastatic renal cell cancer (mRCC) who were treated with bevacizumab at the recommended dose of 10 milligram per kilogram (mg/kg) of body weight once every 2 weeks as an intravenous infusion, in combination with interferon alpha-2a at the recommended starting dose of 9 million international units (MIU) 3 times a week until disease progression were observed. No diagnostic or therapeutic interventions were given other than used in normal daily routine. |
|
|
| Primary | Percentage of Participants With Disease Control | Disease control was defined as having achieved CR, PR, and/or SD during the course of the observation. CR: disappearance of all target lesions and all pathological lymph nodes below 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions. | FAS. 'Number of participants analyzed' indicate participants who were evaluable for this measure. | Posted | Number | percentage of participants | Baseline until progression or intolerable toxicity, whichever occurred first, assessed up to 6 years |
|
|
|
| Primary | Progression-free Survival (PFS) Time | PFS time is defined as time between start of therapy and progression or death. Kaplan-Meier estimate was used for evaluation. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions. | FAS | Posted | Median | 95% Confidence Interval | months | Baseline until progression or intolerable toxicity or death, whichever occurred first, assessed up to 6 years |
|
|
|
| Primary | Overall Survival (OS) Time | OS time is defined as time between start of therapy and date of death. Kaplan-Meier estimate was used for evaluation. | FAS | Posted | Median | 95% Confidence Interval | months | Baseline until progression or intolerable toxicity or death, whichever occurred first, assessed up to 6 years |
|
|
|
| Primary | Cumulative Dose of Immunotherapy (Interferon Alpha-2a) in Daily Routine | FAS. Data were not analyzed for this outcome measure as therapy doses and pattern were not recorded numerically. | Posted | Up to 52 weeks |
|
|
| 72 |
| 359 |
| 325 |
| 359 |
| Posterior reversible encephalopathy syndrome | Nervous system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Death | General disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Gastrointestinal perforation | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Peritonitis | Infections and infestations | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Cerebral atrophy | Nervous system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Dementia | Nervous system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Ischaemic cerebral infarction | Nervous system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Leukoencephalopathy | Nervous system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Orthostatic intolerance | Nervous system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Paraplegia | Nervous system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Senile dementia | Nervous system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Sensory loss | Nervous system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Visual field defect | Nervous system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Impaired healing | General disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Multi-organ failure | General disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Angiodysplasia | Vascular disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Arterial thrombosis | Vascular disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Venous thrombosis | Vascular disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Diarrhoea haemorrhagic | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Diverticular perforation | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Large intestinal haemorrhage | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Large intestine perforation | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Rectal tenesmus | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Haemorrhagic diathesis | Blood and lymphatic system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Metastases to abdominal wall | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Abscess intestinal | Infections and infestations | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Infection | Infections and infestations | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Meningitis viral | Infections and infestations | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Rash pustular | Infections and infestations | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Hallucination | Psychiatric disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Aortic valve sclerosis | Cardiac disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Bundle branch block left | Cardiac disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Cardiomyopathy | Cardiac disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Congestive cardiomyopathy | Cardiac disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Mitral valve incompetence | Cardiac disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Tricuspid valve incompetence | Cardiac disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Bladder pain | Renal and urinary disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Bladder tamponade | Renal and urinary disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Nephrotic syndrome | Renal and urinary disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Blood glucose abnormal | Investigations | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Amaurosis | Eye disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Retinal exudates | Eye disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Retinal haemorrhage | Eye disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Liver injury | Hepatobiliary disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Spinal pain | General disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA Version 15.1 | Non-systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| D009369 | Neoplasms |
| D007680 | Kidney 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 |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D016898 | Interferon-alpha |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D001685 | Biological Factors |