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| ID | Type | Description | Link |
|---|---|---|---|
| P01CA081403 | U.S. NIH Grant/Contract | View source | |
| N2001-02 | Other Identifier | NANT Consortium |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Radioactive drugs, such as iodine I 131 metaiodobenzylguanidine, may carry radiation directly to tumor cells and not harm normal cells. Drugs used in chemotherapy, such as carboplatin, etoposide, and melphalan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. An autologous peripheral stem cell or bone marrow transplant may be able to replace blood-forming cells that were destroyed by chemotherapy and radiation therapy. Giving iodine I 131 metaiodobenzylguanidine and combination chemotherapy with an autologous peripheral stem cell or bone marrow transplant may allow more chemotherapy to be given so that more tumor cells are killed. Giving radiation therapy after an autologous peripheral stem cell or bone marrow transplant may kill any remaining tumor cells.
PURPOSE: This phase II trial is studying how well giving iodine I 131 metaiodobenzylguanidine together with combination chemotherapy and radiation therapy works in treating patients who are undergoing an autologous peripheral stem cell or bone marrow transplant for relapsed or refractory neuroblastoma.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to risk (poor-risk group [mixed or no response to induction therapy or progression during or after induction therapy] vs good-risk group [partial response after 4 courses of induction therapy]) and kidney function at study entry (glomerular filtration rate [GFR] ≥ 100 mL/min vs GFR 60-99 mL/min)
After completion of study treatment, patients are followed for 2 years and then periodically thereafter.
PROJECTED ACCRUAL: Approximately 50 patients (40 low-risk patients and 8-10 high-risk patients) will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All the patients enrolled in the study | Experimental | This is a single arm study. The following description applies to all the patients who are enrolled in the study: On Day -21, patients receive 131I-MIBG infusion. On Day -7, Day -6, Day -5, patients receive Carboplatin, Etoposide, Melphalan. On Day -4, patients receive Carboplatin, Etoposide. On Day -3, Day -2, Day -1, patients rest. On Day 0, patients receive peripheral blood stem cell infusion. Dosing of Carboplatin, Etoposide and Melphalan is based upon whole body dosimetry (cGy) estimates. Filgrastim 5 micrograms/kg/day S.C. or IV will be given daily beginning on Day 0. Local radiation therapy is to be given to previously non-irradiated primary and metastatic sites of disease. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Filgrastim | Biological | Filgrastim 5 micrograms/kg/day S.C. or IV will be given daily beginning on Day 0. The first dose should begin four hours after the stem cell infusion is completed. Filgrastim will continue daily until the ANC >=1500/uL for three consecutive days. |
| Measure | Description | Time Frame |
|---|---|---|
| Response (Complete Response, Very Good Partial Response, and Partial Response) at 60-days Post Stem Cell Infusion | Tumor response based on evaluation performed on day 60 or at the time of disease progression/recurrence or start of another treatment - whichever comes first. Such evaluations will include 123I-MIBG scan, CT/MRI, urine catecholamine measurement, and bone marrow analysis (for those with marrow disease at study entry). | Response assessed 60 days post stem cell infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Event-free Survival (EFS) at 3 Years | EFS will be measured from start of treatment until progression, death or start of another treatment - whichever comes first. We report the estimated probability of EFS at 3 years. | 3 years since start of treatment |
| Engraftment DLT |
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DISEASE CHARACTERISTICS:
Diagnosis of relapsed or refractory neuroblastoma
Histologically confirmed and/or demonstration of tumor cells in bone marrow with elevated urinary catecholamine metabolites
High-risk neuroblastoma must meet one of the following:
Measurable disease, defined as at least one metaiodobenzylguanidine (MIBG)-avid target lesion determined by diagnostic MIBG scan within 6 weeks of study entry (tumor sites that have received local irradiation within 3 months of study entry are not considered target lesions)
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Glomerular filtration rate or creatinine clearance ≥ 60 ml/min
Creatinine ≤ 1.5 times normal for age as follows:
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
No prior myeloablative transplantation
More than 3 weeks since prior biologic therapy
Chemotherapy
Radiotherapy
See Disease Characteristics
At least 6 weeks since prior radiotherapy (6 months for craniospinal or whole lung radiotherapy)
No prior total body irradiation
No prior iodine I 131 MIBG (^131I-MIBG)
No prior total abdominal or whole liver radiotherapy
No prior local radiotherapy, including any of the following:
Other
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| Name | Affiliation | Role |
|---|---|---|
| Gregory Yanik, MD | University of Michigan Rogel Cancer Center | Study Chair |
| Katherine K. Matthay, MD | University of California, San Francisco | Principal Investigator |
| John M. Maris, MD | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Childrens Hospital Los Angeles | Los Angeles | California | 90027-0700 | United States | ||
| Lucile Packard Children's Hospital at Stanford University Medical Center |
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Opened to accrual on 12/10/04 & closed to accrual on 07/21/10; suspended 6 times for amendments. Opened at 12 NANT institutions.
1st patient started on treatment on 03/11/05. 50 patients enrolled; all eligible & evaluable for toxicity. 49 patients were evaluable for response.
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| ID | Title | Description |
|---|---|---|
| FG000 | Poor Risk Patients | Poor risk patients are those who experienced a Minor response (MR) or No Response (NR) to induction therapy or progressive disease (PD) during or following induction. |
| FG001 | Good Risk Patients |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Carboplatin | Drug | The carboplatin will be administered as a continuous IV infusion Day - 7 through Day - 4, with dosing based upon pretreatment GFR levels. The carboplatin should be diluted to a concentration of 0.3 mg/ml in D5W 0.45NS and infused concomitantly with etoposide through the same central venous catheter using a "Y" connector; a controlled rate infusion pump is used for each arm of the "Y". |
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| Etoposide | Drug | The etoposide shall be administered day -7 through day -4 via continuous intravenous infusion over 96 hours. For patients with a corrected GFR >= 100 ml/min/1.72 m^2, a dose of 300 mg/m^2/day (10 mg/kg/day if child is < 12 kg) shall be given. For patients with a corrected GFR 60-99 ml/min/1.72 m^2, the etoposide will be administered at a dose of 160 mg/m^2/day (5.3 mg/kg/day). The etoposide will be diluted in D5W 0.45%NS at a concentration of < 0.4 mg/ml. Etoposide should not be mixed with carboplatin, but administered using a Y-connector. |
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| Melphalan | Drug | For patients in either the normal GFR strata (>=100 ml/min/1.73 m^2), or reduced GFR strata (60-99 ml/min/1.73m^2), melphalan shall be administered at a dose of 60 mg/m^2/day (2 mg/kg/day if child is < 12 kg) on day -7, -6, and -5 of study. The melphalan should be infused at a rate of less than 10 mg/minute, and should complete within 1 hour of reconstitution each day. The melphalan should be diluted in 0.9% NaCl at a concentration < 2 mg/ml. The total dosage of melphalan to be administered will be 180 mg/m^2. |
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| Peripheral blood stem cell infusion | Procedure | Stem cells or marrow will be infused on day 0 of study therapy. Where the DMSO concentration in the stem cell product would exceed accepted level for infusion within a 24 hour period, stem cell products may be infused over two days to meet this standard. For purged PBSC: A minimum of 2.0 x 10^6 viable CD34+ cells/kg must be available. For unpurged PBSC, a minimum of 2.0 x 10^6 viable CD34+ cells/kg must be available. Having a back-up of 2.0 x 10^6 viable CD34+ cells/kg purged or unpurged PBSC is recommended but not required. For purged bone marrow, a minimum of 1.5 x10^8 mononuclear cells/kg must be available. |
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| 131I-MIBG | Radiation | Therapeutic 131I MIBG will be synthesized by Draximage Canada.with specific activity between 15 and 25mCi/ml. Radiopurity will be initially determined by Draximage, prior to shipment to participating centers. Free radioiodide content must then be rechecked at the treating center prior to infusion using HPLC or Sep-Pac methodology. |
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| Radiation therapy | Radiation | Local irradiation is to be given to previously non-irradiated primary and metastatic sites of disease. Local irradiation should not start till the patient is medically stable, has an ANC > 1000/uL, platelets > 30,000 / uL, and is > 42 days post transplant. Recommended radiation guidelines consist of 2160 cGy total, given over 12 days using a single 180 cGy fraction/day. Any delay in local radiation that would extend treatment beyond day +84 should be discussed with the study chair. Local radiation will be administered at a participating NANT member site. |
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• Engraftment toxicity: delayed engraftment and/or failure to engraft defined as:
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| From treatment start until 60 days post stem cell infusion |
| Dose Limiting Veno-occlusive Disease (VOD) / Sinusoidal Obstruction Syndrome SOS | Dose limiting veno-occlusive disease (VOD) defined as:
| Between start of MIBG treatment and 60 days post stem cell infusion |
| Palo Alto |
| California |
| 94304 |
| United States |
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94143 | United States |
| AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus | Atlanta | Georgia | 30322 | United States |
| University of Chicago Comer Children's Hospital | Chicago | Illinois | 60637 | United States |
| Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| C.S. Mott Children's Hospital at University of Michigan Medical Center | Ann Arbor | Michigan | 48109-0286 | United States |
| Morgan Stanley Children's Hospital of New York-Presbyterian | New York | New York | 10032 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229-3039 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104-4318 | United States |
| Cook Children's Medical Center - Fort Worth | Fort Worth | Texas | 76104 | United States |
| Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital | Houston | Texas | 77030-2399 | United States |
| Children's Hospital and Regional Medical Center - Seattle | Seattle | Washington | 98105 | United States |
| University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison | Wisconsin | 53792-6164 | United States |
| Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
Good risk patients are those who experienced a Partial Response (PR) following 4 cycles of induction.
| 1st Interim Analysis |
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| 2nd Interim Analysis |
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| 3rd Interim Analysis |
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| COMPLETED |
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| NOT COMPLETED |
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Number of patients who signed the consent form and started treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Poor Risk Patients | Poor risk patients are those who experienced a Minor response (MR) or No Response (NR) to induction therapy or progressive disease (PD) during or following induction. |
| BG001 | Good Risk Patients | Good risk patients are those who experienced a Partial Response (PR) following 4 cycles of induction. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age (in years) at time of treatment start. | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| GFR Status | Pre-therapy glomerular filtration rate: Normal GFR: >= 100 ml/min/1.73 m2 & Low GFR: 60-99 ml/min/1.73 m2 | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Response (Complete Response, Very Good Partial Response, and Partial Response) at 60-days Post Stem Cell Infusion | Tumor response based on evaluation performed on day 60 or at the time of disease progression/recurrence or start of another treatment - whichever comes first. Such evaluations will include 123I-MIBG scan, CT/MRI, urine catecholamine measurement, and bone marrow analysis (for those with marrow disease at study entry). | One patient in the Poor Risk Cohort underwent surgery for resection (of his only measureable lesion) prior to post-treatment assessment and is not evaluable for response. | Posted | Number | participants | Response assessed 60 days post stem cell infusion |
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| Secondary | Event-free Survival (EFS) at 3 Years | EFS will be measured from start of treatment until progression, death or start of another treatment - whichever comes first. We report the estimated probability of EFS at 3 years. | Estimated probability of 3-year progression free survival for all patients enrolled in each risk group. | Posted | Number | Estimated probability | 3 years since start of treatment |
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| Secondary | Engraftment DLT | • Engraftment toxicity: delayed engraftment and/or failure to engraft defined as:
| All patients who began treatment | Posted | Number | participants | From treatment start until 60 days post stem cell infusion |
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| Secondary | Dose Limiting Veno-occlusive Disease (VOD) / Sinusoidal Obstruction Syndrome SOS | Dose limiting veno-occlusive disease (VOD) defined as:
| All patients who began treatment | Posted | Number | participants | Between start of MIBG treatment and 60 days post stem cell infusion |
|
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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 | Poor Risk Patients | Poor risk patients are those who experienced a Minor response (MR) or No Response (NR) to induction therapy or progressive disease (PD) during or following induction. | 12 | 42 | 42 | 42 | ||
| EG001 | Good Risk Patients | Good risk patients are those who experienced a Partial Response (PR) following 4 cycles of induction. | 3 | 8 | 8 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood/Bone Marrow - Other (DELAYED PLATELET ENGRAFTMENT) | Blood and lymphatic system disorders | CTCAE v3.0 | Systematic Assessment |
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| Blood/Bone Marrow - Other (INFUSION OF BACKUP STEM CELLS) | Blood and lymphatic system disorders | CTCAE v3.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE v3.0 | Systematic Assessment |
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| Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | General disorders | CTCAE v3.0 | Systematic Assessment |
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| Hepatobiliary/Pancreas - Other (HEPATOMEGALY) | Hepatobiliary disorders | CTCAE v3.0 | Systematic Assessment |
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| Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils | Infections and infestations | CTCAE v3.0 | Systematic Assessment |
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| Infection with normal ANC or Grade 1 or 2 neutrophils (Blood) | Infections and infestations | CTCAE v3.0 | Systematic Assessment |
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| Infection with normal ANC or Grade 1 or 2 neutrophils (Catheter-related) | Infections and infestations | CTCAE v3.0 | Systematic Assessment |
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| Bilirubin (hyperbilirubinemia) | Investigations | CTCAE v3.0 | Systematic Assessment |
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| Neutrophils/granulocytes (ANC/AGC) | Investigations | CTCAE v3.0 | Systematic Assessment |
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| Platelets | Investigations | CTCAE v3.0 | Systematic Assessment |
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| Weight gain | Investigations | CTCAE v3.0 | Systematic Assessment |
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| Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | CTCAE v3.0 | Systematic Assessment |
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| Pain (Head/headache) | Nervous system disorders | CTCAE v3.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | Systematic Assessment |
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| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | CTCAE v3.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood/Bone Marrow - Other (DELAYED ENGRAFTMENT ANC) | Blood and lymphatic system disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
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| Blood/Bone Marrow - Other (INFUSION OF BACKUP SC FOR DELAYED ENGRAFTMENT) | Blood and lymphatic system disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
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| Febrile neutropenia (fever of unknown origin) | Blood and lymphatic system disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
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| Hemoglobin | Blood and lymphatic system disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
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| Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis) | Blood and lymphatic system disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
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| Lymphatics - Other (CAPILLARY LEAK) | Blood and lymphatic system disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
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| Lymphatics - Other (GENERALIZED EDEMA) | Blood and lymphatic system disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
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| Cardiac Arrhythmia - Other (MURMUR) | Cardiac disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
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| Cardiac Arrhythmia - Other (SINUS TACHYCARDIA) | Cardiac disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
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| Cardiac General - Other (SYSTOLIC MURMUR) | Cardiac disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
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| Supraventricular and nodal arrhythmia (Atrial tachycardia/Paroxysmal Atrial Tachycardia) | Cardiac disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
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| Supraventricular and nodal arrhythmia (Sinus tachycardia) | Cardiac disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
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| Ventricular arrhythmia (Ventricular arrhythmia NOS) | Cardiac disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
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| Hearing: patients with/without baseline audiogram and enrolled in a monitoring program | Ear and labyrinth disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
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| Hearing: patients without baseline audiogram and not enrolled in a monitoring program | Ear and labyrinth disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
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| Otitis, middle ear (non-infectious) | Ear and labyrinth disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
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| Pain (Middle ear) | Ear and labyrinth disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
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| Endocrine - Other (TSH) | Endocrine disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
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| Thyroid function, high (hyperthyroidism, thyrotoxicosis) | Endocrine disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
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| Ocular/Visual - Other (BILATERAL CONJUNCTIVAL HEMORRHAGE) | Eye disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
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| Pain (Eye) | Eye disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
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| Ascites (non-malignant) | Gastrointestinal disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
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| Cheilitis | Gastrointestinal disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
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| Constipation | Gastrointestinal disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
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| Dental: teeth | Gastrointestinal disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
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| Diarrhea | Gastrointestinal disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
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| Distension/bloating, abdominal | Gastrointestinal disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
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| Dry mouth/salivary gland (xerostomia) | Gastrointestinal disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
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| Dysphagia (difficulty swallowing) | Gastrointestinal disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
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| Gastrointestinal - Other (HICCUPS) | Gastrointestinal disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
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| Gastrointestinal - Other (LOOSE TEETH) | Gastrointestinal disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
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| Gastrointestinal - Other (REFLUX) | Gastrointestinal disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
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| Heartburn/dyspepsia | Gastrointestinal disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
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| Hemorrhage, GI (Lower GI NOS) | Gastrointestinal disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
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| Hemorrhage, GI (Oral cavity) | Gastrointestinal disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
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| Hemorrhage, GI (Stomach) | Gastrointestinal disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
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| Hemorrhage, GI (Upper GI NOS) | Gastrointestinal disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
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| Mucositis/stomatitis (clinical exam) (Anus) | Gastrointestinal disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
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| Mucositis/stomatitis (clinical exam) (Esophagus) | Gastrointestinal disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
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| Mucositis/stomatitis (clinical exam) (Oral cavity) | Gastrointestinal disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
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| Mucositis/stomatitis (clinical exam) (Rectum) | Gastrointestinal disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
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| Mucositis/stomatitis (functional/symptomatic) (Large bowel) | Gastrointestinal disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
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| Mucositis/stomatitis (functional/symptomatic) (Oral cavity) | Gastrointestinal disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
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| Mucositis/stomatitis (functional/symptomatic) (Small bowel) | Gastrointestinal disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
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| Mucositis/stomatitis (functional/symptomatic) (Stomach) | Gastrointestinal disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
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| Nausea | Gastrointestinal disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Obstruction, GI (Small bowel NOS) | Gastrointestinal disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Pain (Abdomen NOS) | Gastrointestinal disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Pain (Esophagus) | Gastrointestinal disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Pain (Oral cavity) | Gastrointestinal disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Pain (Oral-gums) | Gastrointestinal disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Pain (Rectum) | Gastrointestinal disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Pain (Stomach) | Gastrointestinal disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Salivary gland changes/saliva | Gastrointestinal disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Typhlitis (cecal inflammation) | Gastrointestinal disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Vomiting | Gastrointestinal disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Constitutional Symptoms - Other (BRITTLE HAIR) | General disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Constitutional Symptoms - Other (RHINORRHEA) | General disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Edema:head and neck | General disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Edema:limb | General disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Edema:trunk/genital | General disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Fatigue (asthenia, lethargy, malaise) | General disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | General disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Irritability (children <3 years of age) | General disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Pain (Chest/thorax NOS) | General disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Pain (Face) | General disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Pain (Pain NOS) | General disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Pain - Other (BROVIAC SITE) | General disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Pain - Other (CVC SITE) | General disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Pain - Other (GENERAL (NOS)) | General disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Pain - Other (MOUTH PAIN) | General disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Pain - Other (MUCOSITIS) | General disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Pain - Other (OROPHANRIX) | General disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Pain - Other (PAROTID GLAND) | General disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Pain - Other (WHOLE BODY) | General disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Rigors/chills | General disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Hepatobiliary/Pancreas - Other (CHOLANGITIS) | Hepatobiliary disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Liver dysfunction/failure (clinical) | Hepatobiliary disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Pain (Liver) | Hepatobiliary disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Portal vein flow | Hepatobiliary disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Cytokine release syndrome/acute infusion reaction | Immune system disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Colitis, infectious (e.g., Clostridium difficile) | Infections and infestations | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) (Blood) | Infections and infestations | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) (Catheter-related) | Infections and infestations | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) (Lung (pneumonia)) | Infections and infestations | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) (Mucosa) | Infections and infestations | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) (Sinus) | Infections and infestations | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) (Skin (cellulitis)) | Infections and infestations | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Infection - Other (ASPERGILLUS OF MOUTH) | Infections and infestations | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Infection - Other (L-PRESEPTAL CELLULITIS) | Infections and infestations | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Infection - Other (ORAL CANDIDA) | Infections and infestations | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Infection - Other (PERIRECTAL CELLULITIS) | Infections and infestations | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Infection - Other (URINE + FOR CYTOMEGALOVIRUS) | Infections and infestations | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Infection - Other (VARICELLA) | Infections and infestations | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Infection with normal ANC or Grade 1 or 2 neutrophils (Blood) | Infections and infestations | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Infection with normal ANC or Grade 1 or 2 neutrophils (Bronchus) | Infections and infestations | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Infection with normal ANC or Grade 1 or 2 neutrophils (Catheter-related) | Infections and infestations | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Infection with normal ANC or Grade 1 or 2 neutrophils (Colon) | Infections and infestations | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Infection with normal ANC or Grade 1 or 2 neutrophils (Lung (pneumonia)) | Infections and infestations | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Infection with normal ANC or Grade 1 or 2 neutrophils (Oral cavity-gums (gingivitis)) | Infections and infestations | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Infection with normal ANC or Grade 1 or 2 neutrophils (Sinus) | Infections and infestations | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Infection with normal ANC or Grade 1 or 2 neutrophils (Small bowel NOS) | Infections and infestations | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Infection with normal ANC or Grade 1 or 2 neutrophils (Upper airway NOS) | Infections and infestations | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Infection with unknown ANC (Catheter-related) | Infections and infestations | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Infection with unknown ANC (Skin (cellulitis)) | Infections and infestations | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Opportunistic infection associated with >=Grade 2 Lymphopenia | Infections and infestations | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Bruising (in absence of Grade 3 or 4 thrombocytopenia) | Injury, poisoning and procedural complications | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Rash: dermatitis associated with radiation (Chemoradiation) | Injury, poisoning and procedural complications | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| ALT, SGPT (serum glutamic pyruvic transaminase) | Investigations | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| AST, SGOT(serum glutamic oxaloacetic transaminase) | Investigations | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Alkaline phosphatase | Investigations | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Bilirubin (hyperbilirubinemia) | Investigations | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Cholesterol, serum-high (hypercholesteremia) | Investigations | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Creatinine | Investigations | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Fibrinogen | Investigations | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| GGT (gamma-Glutamyl transpeptidase) | Investigations | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| INR (International Normalized Ratio of prothrombin time) | Investigations | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Leukocytes (total WBC) | Investigations | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Lymphopenia | Investigations | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Metabolic/Laboratory - Other (CHLORIDE) | Investigations | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Metabolic/Laboratory - Other (DECREASED TOTAL PROTEIN) | Investigations | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Metabolic/Laboratory - Other (HYPERCHLOREMIA) | Investigations | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Metabolic/Laboratory - Other (HYPERCHLORIDEMIA) | Investigations | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Metabolic/Laboratory - Other (HYPERPHOSPHATEMIA) | Investigations | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Metabolic/Laboratory - Other (INCREASED CHLORIDE) | Investigations | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Metabolic/Laboratory - Other (INCREASED FIBRINOGEN) | Investigations | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Metabolic/Laboratory - Other (PRE-ALBUMIN) | Investigations | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Neutrophils/granulocytes (ANC/AGC) | Investigations | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| PTT (Partial Thromboplastin Time) | Investigations | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Platelets | Investigations | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Weight gain | Investigations | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Weight loss | Investigations | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Acidosis (metabolic or respiratory) | Metabolism and nutrition disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Alkalosis (metabolic or respiratory) | Metabolism and nutrition disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Bicarbonate, serum-low | Metabolism and nutrition disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Calcium, serum-high (hypercalcemia) | Metabolism and nutrition disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Calcium, serum-low (hypocalcemia) | Metabolism and nutrition disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Glucose, serum-high (hyperglycemia) | Metabolism and nutrition disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Glucose, serum-low (hypoglycemia) | Metabolism and nutrition disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Magnesium, serum-high (hypermagnesemia) | Metabolism and nutrition disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Magnesium, serum-low (hypomagnesemia) | Metabolism and nutrition disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Phosphate, serum-low (hypophosphatemia) | Metabolism and nutrition disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Potassium, serum-high (hyperkalemia) | Metabolism and nutrition disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Potassium, serum-low (hypokalemia) | Metabolism and nutrition disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Sodium, serum-high (hypernatremia) | Metabolism and nutrition disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Sodium, serum-low (hyponatremia) | Metabolism and nutrition disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Triglyceride, serum-high (hypertriglyceridemia) | Metabolism and nutrition disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Uric acid, serum-high (hyperuricemia) | Metabolism and nutrition disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Muscle weakness, generalized or specific area (not due to neuropathy) (Extremity-lower) | Musculoskeletal and connective tissue disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Muscle weakness, generalized or specific area (not due to neuropathy) (Extremity-upper) | Musculoskeletal and connective tissue disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Musculoskeletal/Soft Tissue - Other (NOT SPECIFIED) | Musculoskeletal and connective tissue disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Musculoskeletal/Soft Tissue - Other (OCCASIONAL ACHES AND PAINS) | Musculoskeletal and connective tissue disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Pain (Back) | Musculoskeletal and connective tissue disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Pain (Bone) | Musculoskeletal and connective tissue disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Pain (Chest wall) | Musculoskeletal and connective tissue disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Pain (Extremity-limb) | Musculoskeletal and connective tissue disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Pain (Joint) | Musculoskeletal and connective tissue disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Pain (Neck) | Musculoskeletal and connective tissue disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Neurology - Other (ACHY FEELING) | Nervous system disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Neurology - Other (DYSTONIC REACTION) | Nervous system disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Neurology - Other (GENERALIZED TENDERNESS) | Nervous system disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Neuropathy: cranial (CN VII Motor-face; Sensory-taste) | Nervous system disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Neuropathy: motor | Nervous system disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Neuropathy: sensory | Nervous system disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Pain (Head/headache) | Nervous system disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Somnolence/depressed level of consciousness | Nervous system disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Syncope (fainting) | Nervous system disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Taste alteration (dysgeusia) | Nervous system disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Tremor | Nervous system disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Confusion | Psychiatric disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Insomnia | Psychiatric disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Mood alteration (Agitation) | Psychiatric disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Mood alteration (Anxiety) | Psychiatric disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Mood alteration (Depression) | Psychiatric disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Psychosis (hallucinations/delusions) | Psychiatric disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Bladder spasms | Renal and urinary disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Cystitis | Renal and urinary disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Hemoglobinuria | Renal and urinary disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Hemorrhage, GU (Bladder) | Renal and urinary disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Hemorrhage, GU (Urinary NOS) | Renal and urinary disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Pain (Bladder) | Renal and urinary disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Proteinuria | Renal and urinary disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Renal/Genitourinary - Other (DECREASED URINE OUTPUT) | Renal and urinary disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Renal/Genitourinary - Other (FLUID RETENTION) | Renal and urinary disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Urinary retention (including neurogenic bladder) | Renal and urinary disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Pain (Pelvis) | Reproductive system and breast disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Pain (Penis) | Reproductive system and breast disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Pain (Scrotum) | Reproductive system and breast disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Vaginal mucositis | Reproductive system and breast disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Bronchospasm, wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Hemorrhage, pulmonary/upper respiratory (Nose) | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Hemorrhage, pulmonary/upper respiratory (Respiratory tract NOS) | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Mucositis/stomatitis (clinical exam) (Larynx) | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Mucositis/stomatitis (clinical exam) (Pharynx) | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Mucositis/stomatitis (functional/symptomatic) (Pharynx) | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Nasal cavity/paranasal sinus reactions | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Pain (Larynx) | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Pain (Throat/pharynx/larynx) | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Pleural effusion (non-malignant) | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Pneumonitis/pulmonary infiltrates | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Pulmonary/Upper Respiratory - Other (CONGESTION) | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Pulmonary/Upper Respiratory - Other (HYPERCARBIA) | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Pulmonary/Upper Respiratory - Other (RHINORRHEA) | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Pulmonary/Upper Respiratory - Other (RUNNY NOSE) | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Pulmonary/Upper Respiratory - Other (TACHYPNEIC) | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Dermatology/Skin - Other (DRY LIPS) | Skin and subcutaneous tissue disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Dermatology/Skin - Other (FACIAL ABRAISIONS) | Skin and subcutaneous tissue disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Dermatology/Skin - Other (INGROWN TOENAIL) | Skin and subcutaneous tissue disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Dermatology/Skin - Other (LACERATION) | Skin and subcutaneous tissue disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Dermatology/Skin - Other (PEELING SKIN) | Skin and subcutaneous tissue disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Dermatology/Skin - Other (PERIORBITAL ECCHYMOSES) | Skin and subcutaneous tissue disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Dermatology/Skin - Other (PSEUDOMEMBRANOUS CHANGES) | Skin and subcutaneous tissue disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Dermatology/Skin - Other (SORE/SCAB) | Skin and subcutaneous tissue disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Dermatology/Skin - Other (SUN BURN) | Skin and subcutaneous tissue disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Dermatology/Skin - Other (ZOSTER LESION) | Skin and subcutaneous tissue disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Hair loss/alopecia (scalp or body) | Skin and subcutaneous tissue disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Hypopigmentation | Skin and subcutaneous tissue disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Petechiae/purpura (hemorrhage/bleeding into skin or mucosa) | Skin and subcutaneous tissue disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Pruritus/itching | Skin and subcutaneous tissue disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Rash: erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis) | Skin and subcutaneous tissue disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Rash: hand-foot skin reaction | Skin and subcutaneous tissue disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Skin breakdown/decubitus ulcer | Skin and subcutaneous tissue disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Sweating (diaphoresis) | Skin and subcutaneous tissue disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Ulceration | Skin and subcutaneous tissue disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Flushing | Vascular disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Hematoma | Vascular disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Hemorrhage/Bleeding - Other (EPISTAXIS) | Vascular disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Hemorrhage/Bleeding - Other (EYE) | Vascular disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Hemorrhage/Bleeding - Other (HEMATURIA) | Vascular disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Hemorrhage/Bleeding - Other (HEMOPTYSIS) | Vascular disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Hemorrhage/Bleeding - Other (NOSE BLEED) | Vascular disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Hemorrhage/Bleeding - Other (TONGUE BLEED) | Vascular disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Hypertension | Vascular disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
| Hypotension | Vascular disorders | CTCAE v3.0 | Systematic Assessment | We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes. |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Araz Marachelian, MD, NANT Medical Director | Chidlren's Hospital Los Angeles | 323-3691-5687 | amarachelian@chla.usc.edu |
| ID | Term |
|---|---|
| D009447 | Neuroblastoma |
| ID | Term |
|---|---|
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069585 | Filgrastim |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D016190 | Carboplatin |
| D005047 | Etoposide |
| C061400 | etoposide phosphate |
| D008558 | Melphalan |
| D019797 | 3-Iodobenzylguanidine |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D006146 | Guanidines |
| D000578 | Amidines |
| D007462 | Iodobenzenes |
| D001555 | Benzene Derivatives |
| D006847 | Hydrocarbons, Iodinated |
| D013812 | Therapeutics |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Low GFR |
|
|
|
|