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| Name | Class |
|---|---|
| Massachusetts General Hospital | OTHER |
| M.D. Anderson Cancer Center | OTHER |
| MOUNT SINAI HOSPITAL | OTHER |
| Novartis |
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Since thyroid cancer becomes refractory to radioactive iodine, treatment options are very limited. Tyrosine kinase inhibitors such as sorafenib have recently shown promise. This trial seeks to expand treatment options for this disease with a new, oral drug called RAD001. It is an inhibitor of the mTOR pathway and has shown activity in neuroendocrine cancers of the gastrointestinal tract and has been approved for the treatment of metastatic renal cell cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | RAD001 will be administered orally as once daily dose of 10 mg (one 10mg tablet or two 5mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RAD001 | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Median Progression Free Survival | Progression free survival (PFS) is defined as the time from start of treatment to disease progression or death from any cause as estimated by Kaplan Meier methods. Progression is measured using RECIST 1.1 criteria, defined as at least a 20% increase in size in target lesion and/or unequivocal progression of non-target lesions and/or appearance of new lesions. Patients who have not progressed and are alive are censored at the date the patient is known to be progression-free. | Every 2 months for first 24 months, then every 3 months from >24 to 60 months; up to 48 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | The objective response rate is the proportion of participants achieving complete response (CR) or partial response (PR) on treatment based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1) criteria. PR or better is achieved if the following are true: Target Lesions: -At least a 30% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Non-target Lesions: No progression. No appearance new lesions or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase. Bone Lesions: ->50% increase in lesions. -No new lesions. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Glenn Hanna, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Dana-Farber Cancer Institute |
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July 2009 to August 2013
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| ID | Title | Description |
|---|---|---|
| FG000 | RAD001 Group | RAD001 will be administered orally as once daily dose of 10 mg (one 10mg tablet or two 5mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity. RAD001: Taken orally once a day in the morning |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A | RAD001 will be administered orally as once daily dose of 10 mg (one 10mg tablet or two 5mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity. RAD001: Taken orally once a day in the morning |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Median Progression Free Survival | Progression free survival (PFS) is defined as the time from start of treatment to disease progression or death from any cause as estimated by Kaplan Meier methods. Progression is measured using RECIST 1.1 criteria, defined as at least a 20% increase in size in target lesion and/or unequivocal progression of non-target lesions and/or appearance of new lesions. Patients who have not progressed and are alive are censored at the date the patient is known to be progression-free. | Posted | Median | 95% Confidence Interval | months | Every 2 months for first 24 months, then every 3 months from >24 to 60 months; up to 48 months. |
|
Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
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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 | Arm A | RAD001 will be administered orally as once daily dose of 10 mg (one 10mg tablet or two 5mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity. RAD001: Taken orally once a day in the morning |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac-ischemia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Glenn Hanna | Dana-Farber Cancer Institute | 6176323090 | glenn_hanna@dfci.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 28, 2014 | Aug 12, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
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| ID | Term |
|---|---|
| D000068338 | Everolimus |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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Not provided
| INDUSTRY |
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| Every 2 months for first 24 months, then every 3 months from >24 to 60 months; up to 48 months. |
| Median Overall Survival | Overall Survival (OS) is defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive. | Every 2 months for first 24 months, then every 3 months from >24 to 60 months; up to 5 years post study registration. |
| Mean Change in Quality of Life [Medullary Thyroid Cancer Population Only] | The M. D. Anderson Symptom Inventory (MDASI) questionnaire was used to assess quality of life. Questions 1 to 19 were scored. Each of the 19 questions have a response range of 0 - 10, where 0 represents "not present" and 10 represents "as bad as you can imagine". The 19 responses are averaged together to create a mean score, with a lower score indicating a better quality of life. All questionnaire mean scores at each timepoint are averaged together to give a mean score at that timepoint (baseline and week 8) The mean change in quality of life is calculated by subtracting the baseline mean score from the week 8 mean score. | Measured at baseline and then again at cycle 8 (8 months). |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Mt. Sinai Medical Center | New York | New York | 10029 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Adverse Event |
|
| Physician Decision |
|
| Still on protocol treatment/ No documentation to say off protocol treatment |
|
| Lost to Follow-up |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Subtype | Count of Participants | Participants |
|
| Previous Therapies | Count of Participants | Participants |
|
| ECOG Performance Status | Count of Participants | Participants |
|
| Site of Distant Metastasis | Count of Participants | Participants |
|
|
|
|
| Secondary | Objective Response Rate | The objective response rate is the proportion of participants achieving complete response (CR) or partial response (PR) on treatment based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1) criteria. PR or better is achieved if the following are true: Target Lesions: -At least a 30% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Non-target Lesions: No progression. No appearance new lesions or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase. Bone Lesions: ->50% increase in lesions. -No new lesions. | Posted | Number | 95% Confidence Interval | percentage of participants | Every 2 months for first 24 months, then every 3 months from >24 to 60 months; up to 48 months. |
|
|
|
| Secondary | Median Overall Survival | Overall Survival (OS) is defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive. | Posted | Median | 95% Confidence Interval | months | Every 2 months for first 24 months, then every 3 months from >24 to 60 months; up to 5 years post study registration. |
|
|
|
| Secondary | Mean Change in Quality of Life [Medullary Thyroid Cancer Population Only] | The M. D. Anderson Symptom Inventory (MDASI) questionnaire was used to assess quality of life. Questions 1 to 19 were scored. Each of the 19 questions have a response range of 0 - 10, where 0 represents "not present" and 10 represents "as bad as you can imagine". The 19 responses are averaged together to create a mean score, with a lower score indicating a better quality of life. All questionnaire mean scores at each timepoint are averaged together to give a mean score at that timepoint (baseline and week 8) The mean change in quality of life is calculated by subtracting the baseline mean score from the week 8 mean score. | Only 8 of the 10 participants with Medullary Thyroid Cancer filled out both questionnaires (one at baseline and one at cycle 8). | Posted | Mean | Standard Deviation | mean change in score on the MDASI scale | Measured at baseline and then again at cycle 8 (8 months). |
|
|
|
| 3 |
| 50 |
| 36 |
| 50 |
| 50 |
| 50 |
| Hematologic-other | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Diarrhea w/o prior colostomy | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Muco/stomatitis by exam, oral cavity | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Muco/stomatitis (symptom) oral cavity | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| GI-other | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fever w/o neutropenia | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Constitutional, other | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Infection w/ gr3-4 neut, skin | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Infection Gr0-2 neut, lung | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Infection Gr0-2 neut, pharynx | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Infection Gr0-2 neut, upper airway | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Infection-other | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Lymphopenia | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Neutrophils | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Platelets | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Weight loss | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| ALT, SGPT | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Amylase | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Hypercholesterolemia | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Creatinine | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Lipase | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypertriglyceridemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Musculoskeletal/soft tissue-other | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Joint, pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Taste disturbance | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neurologic-other | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Head/headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pleural effusion (non-malignant) | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pneumonitis/pulmonary infiltrates | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pulmonary/Upper Respiratory-other | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hand-foot reaction | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Thrombosis/thrombus/embolism | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pericardial effusion (non-malignant) | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Tootheache | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dysgeunsia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vascular Disorder - Other | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Infection Gr0-2 neut, upper airway | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Infection w/ unk ANC lung | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Infection w/ unk ANC upper airway NOS | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Infection w/ unk ANC urinary tract NOS | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Speech impairment | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hemolysis | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hematologic-other | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Lymphatics-other | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Arrhythmia-other | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Left ventricular systolic dysfunction | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
|
| Middle ear, pain | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dry eye syndrome | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Ocular surface disease | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vision-blurred | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vision-photophobia | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Tearing | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Ocular-other | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Chelitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Ascites (non-malignant) | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Diarrhea w/o prior colostomy | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Distention/bloating, abdominal | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hemorrhoids | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Incontinence, anal | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Muco/stomatitis by exam, oral cavity | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Muco/stomatitis (symptom) oral cavity | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Salivary | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Ulcer, gastric | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| GI-other | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anus, hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Oral cavity, hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rectum, hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Abdomen, pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dental/teeth/peridontal, pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Oral cavity, pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Oral gums, pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fever w/o neutropenia | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Constitutional, other | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Edema head and neck | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Edema limb | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Chest/thoracic pain NOS | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Face, pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain NOS | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain-other | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Flu-like syndrome | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Syndromes-other | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hepatic-other | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Liver, pain | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Allergic reaction | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Allergy-other | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Infection w/ gr3-4 neut, lung | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Infection Gr0-2 neut, dental-tooth | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Infection Gr0-2 neut, eye NOS | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Infection Gr0-2 neut, lung | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Infection Gr0-2 neut, middle ear | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Infection Gr0-2 neut, oral cavity | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Infection Gr0-2 neut, salivary | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Infection Gr0-2 neut, sinus | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Infection Gr0-2 neut, skin | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Infection Gr0-2 neut, ungual | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Infection Gr0-2 neut, urinary tract | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Infection w/ unk ANC sinus | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Infection-other | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Wound - non-infectious | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Leukocytes | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Lymphopenia | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Neutrophils | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Platelets | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Weight gain | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Weight loss | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Coagulation-other | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Alkaline phosphatase | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| ALT, SGPT | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Amylase | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| AST, SGOT | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Hypercholesterolemia | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Creatinine | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Lipase | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Metabolic/Laboratory-other | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Pancreatic glucose intolerance | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Alkalosis | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypernatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypertriglyceridemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nonneuropathic lower extr muscle weak | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nonneuropathic upper extr muscle weak | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Musculoskeletal/soft tissue-other | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Back, pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Bone, pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Chest wall, pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Extremity-limb, pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Joint, pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Muscle, pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neck, pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Taste disturbance | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neuropathy CN VIII hearing + balance | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neuropathy-motor | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neuropathy-sensory | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Tremor | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Neurologic-other | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Head/headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neuropathic, pain | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Confusion | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Libido | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary hemorrhage NOS | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Bladder, pain | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urethra, pain | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cystitis | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Incontinence urinary | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Obstruction-bladder | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Obstruction-ureteral | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary frequency/urgency | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urine color | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Renal/GU-other | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pelvic, pain | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Scrotum, pain | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Testicle, pain | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sexual/Reproductive function-Other | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nose, hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pleura, pain | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Throat/pharynx/larynx, pain | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Bronchospasm, wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Edema, larynx | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fistula trachea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nasal cavity/paranasal sinus reaction | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pleural effusion (non-malignant) | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pneumonitis/pulmonary infiltrates | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Voice changes/dysarthria | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pulmonary/Upper Respiratory-other | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sweating | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypopigmentation | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Induration/fibrosis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nail changes | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pruritus/itching | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rash: acne/acneiform | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hand-foot reaction | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Ulceration | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Skin-other | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Skin, pain | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Flushing | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hot flashes | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hemorrhage-other | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dermal change lymphedema | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Thrombosis/thrombus/embolism | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vascular-Other (Specify) | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D004700 |
| Endocrine System Diseases |
| D013959 | Thyroid Diseases |