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Early termination due to slow enrollment and protocol-defined stopping rule.
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This study will define the safety and efficacy of Everolimus (RAD001) administered daily in patients with glioblastoma multiforme (GBM)
This was a multicenter, open label, randomized study of RAD001 dosed daily in patients with recurrent GBM. The study was conducted with 2 parallel groups of patients. Group 1 was designed to study the biological effects of RAD001 in patients scheduled to undergo salvage surgical resection, and Group 2 was to enroll patients who were not scheduled for surgery. Patients in Group 1 were randomly assigned to one of three pre-surgery treatment groups (0, 5 or 10 mg/day RAD001 for 7 days). All patients in Group 2 were to receive a fixed daily dose of 10 mg/day oral RAD001.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Surgery (Everolimus 10 mg) | Experimental | Participants with recurrent Glioblastoma Multiforme (GBM) not scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus (RAD001) until evidence of disease progression or toxicity. |
|
| Everolimus 10 mg + Surgery | Experimental | Participants scheduled to undergo salvage surgical resection received a daily oral dose of 10 mg Everolimus for 7 days prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity. |
|
| Everolimus 5 mg + Surgery | Experimental | Participants scheduled to undergo salvage surgical resection received a daily oral dose of 5 mg Everolimus for 7 days prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity. |
|
| Everolimus 0 mg + Surgery | Active Comparator | Participants scheduled to undergo salvage surgical resection received no treatment with Everolimus prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Everolimus | Drug | Tablets taken once a day with a full glass of water. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Surgery Group: Percentage Change From the Baseline in S6 Kinase Levels | In the Surgery Group, the primary efficacy assessment was inhibition of Mammalian target of rapamycin (mTOR) as defined as ≥75% S6 phosphorylation. The occurrence of S6 phosphorylation was determined by phosphor-S6 immunohistochemical staining. Tumor cells from the initial surgical resection and from the salvage resection were used for assessments. | Baseline and Day 7-9 (during salvage surgery) |
| No Surgery Group: Best Overall Tumor Response | The best overall tumor response is reported for participants with 1 previous relapse and participants with ≥2 previous relapses according to the following categories: Complete Response, Partial Response, Stable Disease and Progressive Disease. Gadolinium chelate-enhanced Magnetic Resonance Imaging (MRI) was used for tumor analysis. The objective assessment of tumor response was evaluated at each site by the designated pathologist based on the Neuro-Oncology criteria for Tumor Response for Central Nervous System (CNS) tumors. | First day of treatment to study discontinuation (up to 60 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Surgery Group: Blood and Brain Tissue Levels of Everolimus (RAD001) | Baseline and Day 7-9 (Blood samples were collected one day prior to surgery and tissue samples were collected during surgery.) | |
| Surgery Group: Progression-free Survival | Progression-free survival (PFS) was assessed using Gadolinium chelate-enhanced Magnetic Resonance Imaging (MRI) and based on the Neuro-Oncology Criteria for Tumor Response for CNS tumors. PFS was measured from the first day of treatment after surgery to disease progression or death and is derived using the Kaplan-Meier method. |
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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 |
|---|---|---|---|---|---|---|
| UCLA | Los Angeles | California | 90095 | United States | ||
| Northwestern University |
Eligible participants were separated into 2 Groups: Group 1 (Surgery Group) patients were scheduled for salvage surgery and randomly assigned to one of 3 pre-surgery treatment groups: 0, 5 or 10 mg/day Everolimus for 7 days. Group 2 (No Surgery Group) patients were not scheduled for salvage surgery and received 10 mg/day Everolimus.
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| ID | Title | Description |
|---|---|---|
| FG000 | No Surgery (Everolimus 10 mg) | Participants with recurrent Glioblastoma Multiforme (GBM) not scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus (RAD001) until evidence of disease progression or toxicity. |
| FG001 | Everolimus 10 mg + Surgery | Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus for 7 days prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity. |
| FG002 | Everolimus 5 mg + Surgery | Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 5 mg Everolimus for 7 days prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity. |
| FG003 | Everolimus 0 mg + Surgery | Participants scheduled to undergo salvage surgical resection, received no treatment with Everolimus prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | No Surgery (Everolimus 10 mg) | Participants with recurrent Glioblastoma Multiforme (GBM) not scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus (RAD001) until evidence of disease progression or toxicity. |
| BG001 | Everolimus 10 mg + Surgery |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Surgery Group: Percentage Change From the Baseline in S6 Kinase Levels | In the Surgery Group, the primary efficacy assessment was inhibition of Mammalian target of rapamycin (mTOR) as defined as ≥75% S6 phosphorylation. The occurrence of S6 phosphorylation was determined by phosphor-S6 immunohistochemical staining. Tumor cells from the initial surgical resection and from the salvage resection were used for assessments. | Study was terminated due to slow enrollment. | Posted | Number | Percentage change in S6 kinase | Baseline and Day 7-9 (during salvage surgery) |
|
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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 | Everolimus 10 mg + Surgery | Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus for 7 days prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA 10.X | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 10.X | Systematic Assessment |
Due to the early termination of this study, the analysis of some of the planned objectives is not included in this clinical study report.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
Not provided
| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| C535729 | Dyschromatosis symmetrica hereditaria 1 |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| ID | Term |
|---|---|
| D000068338 | Everolimus |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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|
| Surgery | Procedure | Salvage surgical resection |
|
| After surgery (within 96 hours), Weeks 4 and 8 and then every 8 weeks after restarting treatment until study discontinuation (Up to 28 weeks) |
| Surgery Group: Biomarkers Phosphatase and Tensin Homolog (PTEN) and Epidermal Growth Factor Receptor (EGFR) | The secondary efficacy assessment was to evaluate the role of PTEN and EGFR pathway status on phosphor-S6. Tumor cells from the initial surgical resection and from the salvage resection were used for assessments. Immunohistochemistry and Fluorescence in-situ hybridization (FISH) were used to assess PTEN and EGFR pathway status. Study was terminated due to slow enrollment. Analysis was not possible due to insufficient sample size. | After surgery, week 4, week 8 and every 8 weeks thereafter |
| No Surgery Group: Progression Free Survival | Progression-free survival (PFS) was assessed using Gadolinium chelate-enhanced Magnetic Resonance Imaging (MRI) and based on the Neuro-Oncology Criteria for Tumor Response for CNS tumors. PFS is reported for participants with 1 previous relapse and participants with ≥2 previous relapses. PFS was measured from the first day of treatment to disease progression or death and is derived using the Kaplan-Meier method. | First day of treatment to study discontinuation (up to 60 weeks) |
| Surgery Group: Number of Participants With Adverse Events | The number of participants with any adverse event by System Organ Class. Additional information about Adverse Events can be found in the Adverse Event Section. | First day of treatment to study discontinuation (Up to 28 weeks) |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02115 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| Duke University - Preston Robert Tisch Brain Tumor Center | Durham | North Carolina | 27710 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45219 | United States |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | United States |
| Administrative |
|
| Withdrawal by Subject |
|
| Unsatisfactory therapeutic effect |
|
| Lost to Follow-up |
|
| Study drug no longer required |
|
| Death |
|
Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus for 7 days prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity. |
| BG002 | Everolimus 5 mg + Surgery | Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 5 mg Everolimus for 7 days prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity. |
| BG003 | Everolimus 0 mg + Surgery | Participants scheduled to undergo salvage surgical resection, received no treatment with Everolimus prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Everolimus 5 mg + Surgery | Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 5 mg Everolimus for 7 days prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity. |
| OG002 | Everolimus 0 mg + Surgery | Participants scheduled to undergo salvage surgical resection, received no treatment with Everolimus prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity. |
|
| Primary | No Surgery Group: Best Overall Tumor Response | The best overall tumor response is reported for participants with 1 previous relapse and participants with ≥2 previous relapses according to the following categories: Complete Response, Partial Response, Stable Disease and Progressive Disease. Gadolinium chelate-enhanced Magnetic Resonance Imaging (MRI) was used for tumor analysis. The objective assessment of tumor response was evaluated at each site by the designated pathologist based on the Neuro-Oncology criteria for Tumor Response for Central Nervous System (CNS) tumors. | No Surgery Group participants from the Intent-to-treat (ITT) population who received at least one dose of study medication. | Posted | Number | Participants | First day of treatment to study discontinuation (up to 60 weeks) |
|
|
|
| Secondary | Surgery Group: Blood and Brain Tissue Levels of Everolimus (RAD001) | Study was terminated due to slow enrollment. | Posted | Mean | Standard Deviation | Levels | Baseline and Day 7-9 (Blood samples were collected one day prior to surgery and tissue samples were collected during surgery.) |
|
|
| Secondary | Surgery Group: Progression-free Survival | Progression-free survival (PFS) was assessed using Gadolinium chelate-enhanced Magnetic Resonance Imaging (MRI) and based on the Neuro-Oncology Criteria for Tumor Response for CNS tumors. PFS was measured from the first day of treatment after surgery to disease progression or death and is derived using the Kaplan-Meier method. | Results for the Surgery Group only include patients with residual tumor following salvage surgery. | Posted | Median | 95% Confidence Interval | Weeks | After surgery (within 96 hours), Weeks 4 and 8 and then every 8 weeks after restarting treatment until study discontinuation (Up to 28 weeks) |
|
|
|
| Secondary | Surgery Group: Biomarkers Phosphatase and Tensin Homolog (PTEN) and Epidermal Growth Factor Receptor (EGFR) | The secondary efficacy assessment was to evaluate the role of PTEN and EGFR pathway status on phosphor-S6. Tumor cells from the initial surgical resection and from the salvage resection were used for assessments. Immunohistochemistry and Fluorescence in-situ hybridization (FISH) were used to assess PTEN and EGFR pathway status. Study was terminated due to slow enrollment. Analysis was not possible due to insufficient sample size. | Study was terminated due to slow enrollment. | Posted | Mean | Standard Deviation | Levels | After surgery, week 4, week 8 and every 8 weeks thereafter |
|
|
| Secondary | No Surgery Group: Progression Free Survival | Progression-free survival (PFS) was assessed using Gadolinium chelate-enhanced Magnetic Resonance Imaging (MRI) and based on the Neuro-Oncology Criteria for Tumor Response for CNS tumors. PFS is reported for participants with 1 previous relapse and participants with ≥2 previous relapses. PFS was measured from the first day of treatment to disease progression or death and is derived using the Kaplan-Meier method. | No Surgery Group participants from the Intent-to-treat (ITT) population who received at least one dose of study medication. | Posted | Median | 95% Confidence Interval | Weeks | First day of treatment to study discontinuation (up to 60 weeks) |
|
|
|
| Secondary | Surgery Group: Number of Participants With Adverse Events | The number of participants with any adverse event by System Organ Class. Additional information about Adverse Events can be found in the Adverse Event Section. | Surgery Group participants from the Safety population who received at least one dose of study medication. | Posted | Number | Participants | First day of treatment to study discontinuation (Up to 28 weeks) |
|
|
|
| 1 |
| 6 |
| 6 |
| 6 |
| EG001 | Everolimus 5 mg + Surgery | Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 5 mg Everolimus for 7 days prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity. | 1 | 5 | 5 | 5 |
| EG002 | Everolimus 0 mg + Surgery | Participants scheduled to undergo salvage surgical resection, received no treatment with Everolimus prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity. | 2 | 6 | 6 | 6 |
| EG003 | No Surgery (Everolimus 10 mg) | Participants with recurrent Glioblastoma Multiforme (GBM) not scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus (RAD001) until evidence of disease progression or toxicity. | 6 | 24 | 20 | 24 |
| Gait Disturbance | General disorders | MedDRA 10.X | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 10.X | Systematic Assessment |
|
| Bacterial Diarrhoea | Infections and infestations | MedDRA 10.X | Systematic Assessment |
|
| Meningitis | Infections and infestations | MedDRA 10.X | Systematic Assessment |
|
| Perirectal Abscess | Infections and infestations | MedDRA 10.X | Systematic Assessment |
|
| Pneumocystis Jiroveci Pneumonia | Infections and infestations | MedDRA 10.X | Systematic Assessment |
|
| Wound infection Staphylococcal | Infections and infestations | MedDRA 10.X | Systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 10.X | Systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 10.X | Systematic Assessment |
|
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA 10.X | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 10.X | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 10.X | Systematic Assessment |
|
| Neuropathy Peripheral | Nervous system disorders | MedDRA 10.X | Systematic Assessment |
|
| Pneumocephalus | Nervous system disorders | MedDRA 10.X | Systematic Assessment |
|
| intracranial Hypotension | Nervous system disorders | MedDRA 10.X | Systematic Assessment |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 10.X | Systematic Assessment |
|
| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 10.X | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 10.X | Systematic Assessment |
|
| Lymph Node Pain | Blood and lymphatic system disorders | MedDRA 10.X | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 10.X | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 10.X | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 10.X | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 10.X | Systematic Assessment |
|
| Ear Discomfort | Ear and labyrinth disorders | MedDRA 10.X | Systematic Assessment |
|
| Hypoacusis | Ear and labyrinth disorders | MedDRA 10.X | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 10.X | Systematic Assessment |
|
| Cushingoid | Endocrine disorders | MedDRA 10.X | Systematic Assessment |
|
| Vision Blurred | Eye disorders | MedDRA 10.X | Systematic Assessment |
|
| Aphthous Stomatitis | Gastrointestinal disorders | MedDRA 10.X | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 10.X | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.X | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 10.X | Systematic Assessment |
|
| Frequent Bowel Movements | Gastrointestinal disorders | MedDRA 10.X | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 10.X | Systematic Assessment |
|
| Lip Pain | Gastrointestinal disorders | MedDRA 10.X | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 10.X | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 10.X | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 10.X | Systematic Assessment |
|
| Facial Pain | General disorders | MedDRA 10.X | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 10.X | Systematic Assessment |
|
| Irritability | General disorders | MedDRA 10.X | Systematic Assessment |
|
| Localised Oedema | General disorders | MedDRA 10.X | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 10.X | Systematic Assessment |
|
| Oedema Peripheral | General disorders | MedDRA 10.X | Systematic Assessment |
|
| Pain | General disorders | MedDRA 10.X | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 10.X | Systematic Assessment |
|
| Drug Hypersensitivity | Immune system disorders | MedDRA 10.X | Systematic Assessment |
|
| Seasonal Allergy | Immune system disorders | MedDRA 10.X | Systematic Assessment |
|
| Fungal Skin infection | Infections and infestations | MedDRA 10.X | Systematic Assessment |
|
| Gastroenteritis Viral | Infections and infestations | MedDRA 10.X | Systematic Assessment |
|
| Herpes Zoster Oticus | Infections and infestations | MedDRA 10.X | Systematic Assessment |
|
| Oral Candidiasis | Infections and infestations | MedDRA 10.X | Systematic Assessment |
|
| Oral Herpes | Infections and infestations | MedDRA 10.X | Systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA 10.X | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 10.X | Systematic Assessment |
|
| Respiratory Tract infection | Infections and infestations | MedDRA 10.X | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 10.X | Systematic Assessment |
|
| Upper Respiratory Tract infection | Infections and infestations | MedDRA 10.X | Systematic Assessment |
|
| Urinary Tract infection | Infections and infestations | MedDRA 10.X | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 10.X | Systematic Assessment |
|
| Endotracheal intubation Complication | Injury, poisoning and procedural complications | MedDRA 10.X | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 10.X | Systematic Assessment |
|
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA 10.X | Systematic Assessment |
|
| Radiation Necrosis | Injury, poisoning and procedural complications | MedDRA 10.X | Systematic Assessment |
|
| incision Site Pain | Injury, poisoning and procedural complications | MedDRA 10.X | Systematic Assessment |
|
| Alanine Aminotransferase increased | Investigations | MedDRA 10.X | Systematic Assessment |
|
| Aspartate Aminotransferase increased | Investigations | MedDRA 10.X | Systematic Assessment |
|
| Blood Albumin Decreased | Investigations | MedDRA 10.X | Systematic Assessment |
|
| Blood Alkaline Phosphatase increased | Investigations | MedDRA 10.X | Systematic Assessment |
|
| Blood Bicarbonate Decreased | Investigations | MedDRA 10.X | Systematic Assessment |
|
| Blood Cholesterol increased | Investigations | MedDRA 10.X | Systematic Assessment |
|
| Blood Triglycerides increased | Investigations | MedDRA 10.X | Systematic Assessment |
|
| Gamma-Glutamyltransferase increased | Investigations | MedDRA 10.X | Systematic Assessment |
|
| Haemoglobin Decreased | Investigations | MedDRA 10.X | Systematic Assessment |
|
| Heart Rate increased | Investigations | MedDRA 10.X | Systematic Assessment |
|
| Low Density Lipoprotein increased | Investigations | MedDRA 10.X | Systematic Assessment |
|
| Oxygen Saturation Decreased | Investigations | MedDRA 10.X | Systematic Assessment |
|
| Platelet Count Decreased | Investigations | MedDRA 10.X | Systematic Assessment |
|
| Protein Total increased | Investigations | MedDRA 10.X | Systematic Assessment |
|
| Weight Decreased | Investigations | MedDRA 10.X | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA 10.X | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 10.X | Systematic Assessment |
|
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 10.X | Systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 10.X | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 10.X | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 10.X | Systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 10.X | Systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 10.X | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 10.X | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 10.X | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 10.X | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 10.X | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 10.X | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 10.X | Systematic Assessment |
|
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA 10.X | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.X | Systematic Assessment |
|
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA 10.X | Systematic Assessment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.X | Systematic Assessment |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA 10.X | Systematic Assessment |
|
| Pain in Jaw | Musculoskeletal and connective tissue disorders | MedDRA 10.X | Systematic Assessment |
|
| Amnesia | Nervous system disorders | MedDRA 10.X | Systematic Assessment |
|
| Aphasia | Nervous system disorders | MedDRA 10.X | Systematic Assessment |
|
| Ataxia | Nervous system disorders | MedDRA 10.X | Systematic Assessment |
|
| Brain Oedema | Nervous system disorders | MedDRA 10.X | Systematic Assessment |
|
| Cognitive Disorder | Nervous system disorders | MedDRA 10.X | Systematic Assessment |
|
| Depressed Level of Consciousness | Nervous system disorders | MedDRA 10.X | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 10.X | Systematic Assessment |
|
| Facial Palsy | Nervous system disorders | MedDRA 10.X | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 10.X | Systematic Assessment |
|
| Hemianopia | Nervous system disorders | MedDRA 10.X | Systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MedDRA 10.X | Systematic Assessment |
|
| Hypogeusia | Nervous system disorders | MedDRA 10.X | Systematic Assessment |
|
| Memory Impairment | Nervous system disorders | MedDRA 10.X | Systematic Assessment |
|
| Mental Impairment | Nervous system disorders | MedDRA 10.X | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 10.X | Systematic Assessment |
|
| Peripheral Motor Neuropathy | Nervous system disorders | MedDRA 10.X | Systematic Assessment |
|
| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA 10.X | Systematic Assessment |
|
| Sinus Headache | Nervous system disorders | MedDRA 10.X | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 10.X | Systematic Assessment |
|
| Speech Disorder | Nervous system disorders | MedDRA 10.X | Systematic Assessment |
|
| Visual Field Defect | Nervous system disorders | MedDRA 10.X | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 10.X | Systematic Assessment |
|
| Confusional State | Psychiatric disorders | MedDRA 10.X | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 10.X | Systematic Assessment |
|
| Hallucination | Psychiatric disorders | MedDRA 10.X | Systematic Assessment |
|
| insomnia | Psychiatric disorders | MedDRA 10.X | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 10.X | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA 10.X | Systematic Assessment |
|
| incontinence | Renal and urinary disorders | MedDRA 10.X | Systematic Assessment |
|
| Sexual Dysfunction | Reproductive system and breast disorders | MedDRA 10.X | Systematic Assessment |
|
| Allergic Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.X | Systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 10.X | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.X | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.X | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 10.X | Systematic Assessment |
|
| Pain of Skin | Skin and subcutaneous tissue disorders | MedDRA 10.X | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 10.X | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.X | Systematic Assessment |
|
| Rash Erythematous | Skin and subcutaneous tissue disorders | MedDRA 10.X | Systematic Assessment |
|
| Rash Maculo-Papular | Skin and subcutaneous tissue disorders | MedDRA 10.X | Systematic Assessment |
|
| Rash Papular | Skin and subcutaneous tissue disorders | MedDRA 10.X | Systematic Assessment |
|
| increased Tendency To Bruise | Skin and subcutaneous tissue disorders | MedDRA 10.X | Systematic Assessment |
|
| Tooth Extraction | Surgical and medical procedures | MedDRA 10.X | Systematic Assessment |
|
| Deep Vein Thrombosis | Vascular disorders | MedDRA 10.X | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 10.X | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 10.X | 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 the publication of the trial results in their entirety.
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| Partial response |
|
| Stable disease |
|
| Progressive disease |
|
|
| General disorders & administration site conditions |
|
| Metabolism and nutrition disorders |
|
| Blood and lymphatic system disorders |
|
| Infections and infestations |
|
| Psychiatric disorders |
|
| Skin and subcutaneous tissue disorders |
|
| Investigations |
|
| Injury, poisoning, and procedural complications |
|
| Musculoskeletal and connective tissue disorders |
|
| Respiratory, thoracic and mediastinal disorders |
|
| Renal and urinary disorders |
|
| Vascular disorders |
|
| Immune system disorders |
|
| Eye disorders |
|
| Ear and labyrinth disorders |
|
| Reproductive system and breast disorders |
|
| Cardiac disorders |
|
| Endocrine disorders |
|
| Surgical and medical procedures |
|
| Neoplasms benign, malignant and unspecified |
|