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| ID | Type | Description | Link |
|---|---|---|---|
| CHNMC-05021 | |||
| CDR0000579141 | Registry Identifier | NCI PDQ | |
| NCI-2010-00427 | Registry Identifier | NCI CTRP | |
| R01CA154491 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Giving intensity modulated radiation therapy (IMRT) and chemotherapy, such as etoposide and cyclophosphamide, before a donor stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving IMRT together with chemotherapy before transplant may stop this from happening.
PURPOSE: This phase I/II trial is studying the side effects and best dose of intensity-modulated radiation therapy (IMRT) when given together with etoposide and cyclophosphamide followed by donor stem cell transplant and to see how well they work in treating patients with relapsed or refractory acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML).
OBJECTIVES: I. To establish the maximum tolerated dose [MTD] of large field image-guided IMRT, using helical tomotherapy when given in combination with intravenous cyclophosphamide and VP-16 as a preparative regimen for allogeneic hematopoietic stem cell transplantation (HSCT) from an human leukocyte antigen (HLA)-identical sibling or unrelated donor in patients with ALL or AML with induction failure or in relapse. (Phase I) II. To describe the toxicity at each dose level standard. (Phase I) III. To collect data on the radiation dose to normal organs and bone marrow using tomotherapy targeted total-body irradiation (TBI). (Phase I) IV. To estimate the overall survival probability, disease free survival probability and relapse rate associated with this regimen. (Phase II) V. To characterize the treatment related mortality and toxicity profile (early/late) associated with this regimen. (Phase II) VI. To descriptively compare the outcomes of patients treated on this protocol to a comparable patient population conditioned with whole body radiation. (Phase II)
OUTLINE: This is a phase I, dose-escalation study of intensity-modulated radiation therapy (IMRT) followed by a phase II study.
PREPARATIVE REGIMEN: Patients undergo IMRT using helical tomotherapy once or twice daily on days -10 to -6 or -10 to -7. Patients also receive etoposide intravenously (IV) on day -6 or -5 and cyclophosphamide IV on day -4 or -3.
TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell or bone marrow transplantation on day -1 or day 0. After completion of study treatment, patients are followed up periodically for up to 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Level 1: 1200cGy | Experimental | 150cGy BID x Days 1-4. Total dose 1200cGy. |
|
| Level 2: 1350cGy | Experimental | 150cGy BID Day 1-4 then 150 cGy QD Day 5. Total dose 1350cGy. |
|
| Level 3: 1500cGy limited dose to ribs, sternum, liver, brain 1200cGy | Experimental | 150cGy BID Day 1-5. Total dose 1500Gy. |
|
| Level 4: 1500cGy limited dose to liver, brain 1200cGy | Experimental | 150cGy BID Day 1-5. Total dose 1500Gy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cyclophosphamide | Drug | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose of Intensity-modulated Radiotherapy (Phase I) | Toxicities will be recorded using two distinct grading systems: the modified Bearman scale and the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 3.0 scale. | 30 days post transplant |
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Inclusion Criteria:
DONOR: Any sibling donors who are histocompatible with the prospective recipient will be considered a suitable donor
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony S. Stein, MD | City of Hope Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010-3000 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Period 1: 1200cGy | 150cGy BID x Days 1-4. Total dose 1200cGy. cyclophosphamide: Given IV etoposide: Given IV allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide intensity-modulated radiation therapy: Undergo IMRT tomotherapy: Undergo IMRT using helical tomotherapy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Level 5: 1600cGy limited dose to liver, porta-hepatic, brain 1200cGy | Experimental | 160cGy BID Day 1-5. Total dose 1600Gy. |
|
| Level 6: 1700cGy limited dose to liver, porta-hepatic, brain 1200cGy | Experimental | 170cGy BID Day 1-5. Total dose 1700Gy. |
|
| Level 7: 1800cGy limited dose to liver, porta-hepatic, brain 1200cGy | Experimental | 180cGy BID Day 1-5. Total dose 1800Gy. |
|
| Level 8: 1900cGy limited dose to liver, porta-hepatic, brain 1200cGy | Experimental | 190cGy BID Day 1-5. Total dose 1900Gy. |
|
| Level 9: 2000cGy limited dose to liver, porta-hepatic, brain 1200cGy | Experimental | 200cGy BID Day 1-5. Total dose 2000Gy. |
|
|
| etoposide | Drug | Given IV |
|
|
| allogeneic bone marrow transplantation | Procedure | Occurs approximately 48 hours after completion of cyclophosphamide |
|
| allogeneic hematopoietic stem cell transplantation | Procedure | Occurs approximately 48 hours after completion of cyclophosphamide |
|
| peripheral blood stem cell transplantation | Procedure | Occurs approximately 48 hours after completion of cyclophosphamide |
|
| intensity-modulated radiation therapy | Radiation | Undergo IMRT |
|
|
| tomotherapy | Radiation | Undergo IMRT using helical tomotherapy |
|
|
| FG001 | Period 2: 1350cGy | 150cGy BID Day 1-4 then 150 cGy QD Day 5. Total dose 1350cGy. cyclophosphamide: Given IV etoposide: Given IV allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide intensity-modulated radiation therapy: Undergo IMRT tomotherapy: Undergo IMRT using helical tomotherapy |
| FG002 | Period 3: 1500cGy (1200 cGy Limited Dose to Ribs, Sternum, Liver, Brain) | 150cGy BID Day 1-5. Total dose 1500Gy. cyclophosphamide: Given IV etoposide: Given IV allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide intensity-modulated radiation therapy: Undergo IMRT tomotherapy: Undergo IMRT using helical tomotherapy |
| FG003 | Period 4: 1500cGy (1200 cGy Limited Dose to Liver, Brain) | 150cGy BID Day 1-5. Total dose 1500Gy. cyclophosphamide: Given IV etoposide: Given IV allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide intensity-modulated radiation therapy: Undergo IMRT tomotherapy: Undergo IMRT using helical tomotherapy |
| FG004 | Period 5: 1600cGy (1200 cGy Limited Dose to Liver, Porta-hepatic, Brain) | 160cGy BID Day 1-5. Total dose 1600Gy. cyclophosphamide: Given IV etoposide: Given IV allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide intensity-modulated radiation therapy: Undergo IMRT tomotherapy: Undergo IMRT using helical tomotherapy |
| FG005 | Period 6: 1700cGy (1200 cGy Limited Dose to Liver, Porta-hepatic, Brain) | 170cGy BID Day 1-5. Total dose 1700Gy. Patient age 18-55 cyclophosphamide: Given IV etoposide: Given IV allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide intensity-modulated radiation therapy: Undergo IMRT tomotherapy: Undergo IMRT using helical tomotherapy |
| FG006 | Period 7: 1800cGy (1200 cGy Limited Dose to Liver, Porta-hepatic, Brain) | 180cGy BID Day 1-5. Total dose 1800cGy. cyclophosphamide: Given IV etoposide: Given IV allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide intensity-modulated radiation therapy: Undergo IMRT tomotherapy: Undergo IMRT using helical tomotherapy |
| FG007 | Period 8: 1900cGy (1200 cGy Limited Dose to Liver, Porta-hepatic, Brain) | 190cGy BID Day 1-5. Total dose 1900cGy. cyclophosphamide: Given IV etoposide: Given IV allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide intensity-modulated radiation therapy: Undergo IMRT tomotherapy: Undergo IMRT using helical tomotherapy |
| FG008 | Period 9: 2000cGy (1200 cGy Limited Dose to Liver, Porta-hepatic, Brain) | 200 cGy BID Day 1-5. Total dose 2000cGy cyclophosphamide: Given IV etoposide: Given IV allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide intensity-modulated radiation therapy: Undergo IMRT tomotherapy: Undergo IMRT using helical tomotherapy |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Level 1: 1200cGy | 150cGy BID x Days 1-4. Total dose 1200cGy. cyclophosphamide: Given IV etoposide: Given IV allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide intensity-modulated radiation therapy: Undergo IMRT tomotherapy: Undergo IMRT using helical tomotherapy |
| BG001 | Level 2: 1350cGy | 150cGy BID Day 1-4 then 150 cGy QD Day 5. Total dose 1350cGy. cyclophosphamide: Given IV etoposide: Given IV allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide intensity-modulated radiation therapy: Undergo IMRT tomotherapy: Undergo IMRT using helical tomotherapy |
| BG002 | Level 3: 1500cGy Limited Dose to Ribs, Sternum, Liver, Brain 1200cGy | 150cGy BID Day 1-5. Total dose 1500cGy. cyclophosphamide: Given IV etoposide: Given IV allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide intensity-modulated radiation therapy: Undergo IMRT tomotherapy: Undergo IMRT using helical tomotherapy |
| BG003 | Level 4: 1500cGy Limited Dose to Liver, Brain 1200cGy | 150cGy BID Day 1-5. Total dose 1500cGy. cyclophosphamide: Given IV etoposide: Given IV allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide intensity-modulated radiation therapy: Undergo IMRT tomotherapy: Undergo IMRT using helical tomotherapy |
| BG004 | Level 5: 1600cGy Limited Dose to Liver, Porta-hepatic, Brain 1200cGy | 160cGy BID Day 1-5. Total dose 1600cGy. cyclophosphamide: Given IV etoposide: Given IV allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide intensity-modulated radiation therapy: Undergo IMRT tomotherapy: Undergo IMRT using helical tomotherapy |
| BG005 | Level 6: 1700cGy Limited Dose to Liver, Porta-hepatic, Brain 1200cGy | 170cGy BID Day 1-5. Total dose 1700cGy. cyclophosphamide: Given IV etoposide: Given IV allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide intensity-modulated radiation therapy: Undergo IMRT tomotherapy: Undergo IMRT using helical tomotherapy |
| BG006 | Level 7: 1800cGy Limited Dose to Liver, Porta-hepatic, Brain 1200cGy | 180cGy BID Day 1-5. Total dose 1800cGy. cyclophosphamide: Given IV etoposide: Given IV allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide intensity-modulated radiation therapy: Undergo IMRT tomotherapy: Undergo IMRT using helical tomotherapy |
| BG007 | Level 8: 1900cGy Limited Dose to Liver, Porta-hepatic, Brain 1200cGy | 190cGy BID Day 1-5. Total dose 1900cGy. cyclophosphamide: Given IV etoposide: Given IV allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide intensity-modulated radiation therapy: Undergo IMRT tomotherapy: Undergo IMRT using helical tomotherapy |
| BG008 | Level 9: 2000cGy Limited Dose to Liver, Porta-hepatic, Brain 1200cGy | 200cGy BID Day 1-5. Total dose 2000cGy. cyclophosphamide: Given IV etoposide: Given IV allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide intensity-modulated radiation therapy: Undergo IMRT tomotherapy: Undergo IMRT using helical tomotherapy |
| BG009 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Tolerated Dose of Intensity-modulated Radiotherapy (Phase I) | Toxicities will be recorded using two distinct grading systems: the modified Bearman scale and the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 3.0 scale. | Posted | Number | cGy | 30 days post transplant |
|
|
|
Up to 2 years. To be evaluable for toxicity, a patient must start treatment and be observed for at least 30 days following the completion of the transplant procedure or have experienced DLT. Hematological toxicities will be evaluated from day 0, the day the patient receives allogeneic cell transplant. No dose escalation will occur until DLT evaluations for all patients on a dose level.
The modified Bearman Scale will be used to define DLT events and the CTCAE 3.0 scale will be used for reporting adverse events. CTCAE version 4.03 is used for reporting adverse events in Arm 9.
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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 | Level 1: 1200cGy | 150cGy BID x Days 1-4. Total dose 1200cGy. cyclophosphamide: Given IV etoposide: Given IV allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide intensity-modulated radiation therapy: Undergo IMRT tomotherapy: Undergo IMRT using helical tomotherapy | 0 | 3 | 0 | 3 | 3 | 3 |
| EG001 | Level 2: 1350cGy | 150cGy BID Day 1-4 then 150 cGy QD Day 5. Total dose 1350cGy. cyclophosphamide: Given IV etoposide: Given IV allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide intensity-modulated radiation therapy: Undergo IMRT tomotherapy: Undergo IMRT using helical tomotherapy | 0 | 3 | 0 | 3 | 3 | 3 |
| EG002 | Level 3: 1500cGy Limited Dose to Ribs, Sternum, Liver, Brain 1200cGy | 150cGy BID Day 1-5. Total dose 1500cGy. cyclophosphamide: Given IV etoposide: Given IV allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide intensity-modulated radiation therapy: Undergo IMRT tomotherapy: Undergo IMRT using helical tomotherapy | 1 | 9 | 1 | 9 | 9 | 9 |
| EG003 | Level 4: 1500cGy Limited Dose to Liver, Brain 1200cGy | 150cGy BID Day 1-5. Total dose 1500cGy. cyclophosphamide: Given IV etoposide: Given IV allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide intensity-modulated radiation therapy: Undergo IMRT tomotherapy: Undergo IMRT using helical tomotherapy | 0 | 6 | 3 | 6 | 6 | 6 |
| EG004 | Level 5: 1600cGy Limited Dose to Liver, Porta-hepatic, Brain 1200cGy | 160cGy BID Day 1-5. Total dose 1600cGy. cyclophosphamide: Given IV etoposide: Given IV allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide intensity-modulated radiation therapy: Undergo IMRT tomotherapy: Undergo IMRT using helical tomotherapy | 0 | 6 | 0 | 6 | 6 | 6 |
| EG005 | Level 6: 1700cGy Limited Dose to Liver, Porta-hepatic, Brain 1200cGy | 170cGy BID Day 1-5. Total dose 1700cGy. cyclophosphamide: Given IV etoposide: Given IV allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide intensity-modulated radiation therapy: Undergo IMRT tomotherapy: Undergo IMRT using helical tomotherapy | 0 | 6 | 0 | 6 | 6 | 6 |
| EG006 | Level 7: 1800cGy Limited Dose to Liver, Porta-hepatic, Brain 1200cGy | 180cGy BID Day 1-5. Total dose 1800cGy. cyclophosphamide: Given IV etoposide: Given IV allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide intensity-modulated radiation therapy: Undergo IMRT tomotherapy: Undergo IMRT using helical tomotherapy | 0 | 6 | 1 | 6 | 6 | 6 |
| EG007 | Level 8: 1900cGy Limited Dose to Liver, Porta-hepatic, Brain 1200cGy | 190cGy BID Day 1-5. Total dose 1900cGy. cyclophosphamide: Given IV etoposide: Given IV allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide intensity-modulated radiation therapy: Undergo IMRT tomotherapy: Undergo IMRT using helical tomotherapy | 0 | 6 | 0 | 6 | 6 | 6 |
| EG008 | Level 9: 2000cGy | 200cGy BID Day 1-5. Total dose 1900cGy. cyclophosphamide: Given IV etoposide: Given IV allogeneic bone marrow transplantation: Occurs approximately 48 hours after completion of cyclophosphamide allogeneic hematopoietic stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide peripheral blood stem cell transplantation: Occurs approximately 48 hours after completion of cyclophosphamide intensity-modulated radiation therapy: Undergo IMRT tomotherapy: Undergo IMRT using helical tomotherapy | 0 | 6 | 1 | 6 | 6 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Cardiac disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Left ventricular systolic dysfunction | Cardiac disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Mucositis/stomatitis (clinical exam) | Gastrointestinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Mucositis/stomatitis (functional/symptomatic) | Gastrointestinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10040047-Sepsis | Infections and infestations | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10005364-Blood bilirubin increased | Investigations | CTCAE 3.0 and 4.03 | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Renal Toxicity | Renal and urinary disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10038695-Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10065746-Bronchopulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Pulmonary Toxicity | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| 10002272-Anemia | Blood and lymphatic system disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Edema:head and neck | Blood and lymphatic system disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Edema:limb | Blood and lymphatic system disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Edema:trunk/genital | Blood and lymphatic system disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis) | Blood and lymphatic system disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Leukocytes (total WBC) | Blood and lymphatic system disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Leukocytes (total WBC) for BMT studies, if specified in the protocol. | Blood and lymphatic system disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Lymphatics - Other (Specify, __) LYMPHADENOPATHY | Blood and lymphatic system disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Neutrophils/granulocytes (ANC/AGC) for BMT studies, if specified in the protocol. | Blood and lymphatic system disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Platelets | Blood and lymphatic system disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Platelets for BMT studies, if specified in the protocol. | Blood and lymphatic system disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Transfusion: Platelets for BMT studies, if specified in the protocol. | Blood and lymphatic system disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Transfusion: pRBCs for BMT studies, if specified in the protocol. | Blood and lymphatic system disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10040741-Sinus bradycardia | Cardiac disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10040752-Sinus tachycardia | Cardiac disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Cardiac Arrhythmia - Other (Specify, __) TACHYCARDIA | Cardiac disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Cardiac Toxicity | Cardiac disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Hypertension | Cardiac disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Hypotension | Cardiac disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Pericardial effusion (non-malignant) | Cardiac disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Pulmonary hypertension | Cardiac disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Supraventricular and nodal arrhythmia | Cardiac disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Cushingoid appearance (e.g., moon face, buffalo hump, centripetal obesity, cutaneous striae) | Endocrine disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Thyroid function, low (hypothyroidism) | Endocrine disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10005886-Blurred vision | Eye disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Dry eye syndrome | Eye disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Ocular/Visual - Other (Specify, __) CLOUDINESS LEFT CORNEA | Eye disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Ocular/Visual - Other (Specify, __) EYES STAY OPEN | Eye disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Ocular/Visual - Other (Specify, __) PALLOR OF CONJUNCTIVAE | Eye disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Ocular/Visual - Other (Specify, __) SCLERAL ICTERUS | Eye disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Vision-blurred vision | Eye disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Watery eye (epiphora, tearing) | Eye disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10000081-Abdominal pain | Gastrointestinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10003445-Ascites | Gastrointestinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10009887-Colitis | Gastrointestinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10010774-Constipation | Gastrointestinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10012727-Diarrhea | Gastrointestinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10013781-Dry mouth | Gastrointestinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10013946-Dyspepsia | Gastrointestinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10013950-Dysphagia | Gastrointestinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10017853-Gastritis | Gastrointestinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10028130-Mucositis oral | Gastrointestinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10028813-Nausea | Gastrointestinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10031009-Oral pain | Gastrointestinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10047700-Vomiting | Gastrointestinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10051746-Lower gastrointestinal hemorrhage | Gastrointestinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10065721-Anal mucositis | Gastrointestinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Anorexia | Gastrointestinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Ascites (non-malignant) | Gastrointestinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Dehydration | Gastrointestinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Distension/bloating, abdominal | Gastrointestinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Dry mouth/salivary gland (xerostomia) | Gastrointestinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Dysphagia (difficulty swallowing) | Gastrointestinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Gastritis (including bile reflux gastritis) | Gastrointestinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Gastrointestinal - Other (Specify, __) BELCHING | Gastrointestinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Gastrointestinal - Other (Specify, __) CHANGE IN BOWEL HABITS | Gastrointestinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Gastrointestinal - Other (Specify, __) FREQUENT BOWEL MVMT | Gastrointestinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Gastrointestinal - Other (Specify, __) GI UPSET | Gastrointestinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Gastrointestinal - Other (Specify, __) LICHENOID CHANGES IN MOUTH | Gastrointestinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Gastrointestinal - Other (Specify, __) MOUTH SORE | Gastrointestinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Gastrointestinal - Other (Specify, __) PERIANAL NUMBNESS | Gastrointestinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| GI Toxicity | Gastrointestinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Heartburn/dyspepsia | Gastrointestinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Incontinence, anal | Gastrointestinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Mucositis/stomatitis (clinical exam) | Gastrointestinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Mucositis/stomatitis (functional/symptomatic) | Gastrointestinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Stomatitis/pharyngitis (oral/pharyngeal mucositis) for BMT studies, if specified in the protocol. | Gastrointestinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Taste alteration (dysgeusia) | Gastrointestinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10008531-Chills | General disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10014222-Edema face | General disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10016059-Facial pain | General disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10016256-Fatigue | General disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10016558-Fever | General disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10017577-Gait disturbance | General disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10018065-General disorders and administration site conditions - Other, specify | General disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10033371-Pain | General disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10050068-Edema limbs | General disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10051792-Infusion related reaction | General disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10062501-Non-cardiac chest pain | General disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Fatigue (asthenia, lethargy, malaise) | General disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | General disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Hypothermia | General disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Insomnia | General disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Pain | General disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Pain - Other (Specify, __) GENERALIZED BODYACHE | General disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Pain - Other (Specify, __) GENERALIZED PAIN | General disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Pain - Other (Specify, __) JAW PAIN | General disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Pain - Other (Specify, __) L/R SIDE BODY PAIN | General disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Pain - Other (Specify, __) MANDIBULAR | General disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Pain - Other (Specify, __) PICC LINE SITE | General disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Pain - Other (Specify, __) PICC SITE | General disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Pain - Other (Specify, __) TOOTH | General disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Pain CHEST NOS LEFT SIDE | General disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Rigors/chills | General disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Syndromes - Other (Specify, __) ENGRAFTMENT SYN | General disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Syndromes - Other (Specify, __) ENGRAFTMENT SYNDROME | General disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Weight gain | General disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Weight loss | General disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Hepatic Toxicity | Hepatobiliary disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Liver dysfunction/failure (clinical) | Hepatobiliary disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | Immune system disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10021881-Infections and infestations - Other, specify | Infections and infestations | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10040753-Sinusitis | Infections and infestations | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10046914-Vaginal infection | Infections and infestations | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10058838-Enterocolitis infectious | Infections and infestations | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10061229-Lung infection | Infections and infestations | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Colitis, infectious (e.g., Clostridium difficile) | Infections and infestations | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Febrile neutropenia | Infections and infestations | CTCAE 3.0 and 4.03 | Systematic Assessment | Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infection)(ANC <1.0 x 10e9/L, fever >=38.5 degrees C) |
|
| Infection - Other (Specify, __) CMV INFECTION | Infections and infestations | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Infection | Infections and infestations | CTCAE 3.0 and 4.03 | Systematic Assessment | Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) |
|
| Infection with normal ANC or Grade 1 or 2 neutrophils | Infections and infestations | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Infection with unknown ANC | Infections and infestations | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Stomatitis | Infections and infestations | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10006504-Bruising | Injury, poisoning and procedural complications | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10061103-Dermatitis radiation | Injury, poisoning and procedural complications | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10000636-Activated partial thromboplastin time prolonged | Investigations | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10001551-Alanine aminotransferase increased | Investigations | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10001675-Alkaline phosphatase increased | Investigations | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10003481-Aspartate aminotransferase increased | Investigations | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10005364-Blood bilirubin increased | Investigations | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10011368-Creatinine increased | Investigations | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10022402-INR increased | Investigations | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10025256-Lymphocyte count decreased | Investigations | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10029366-Neutrophil count decreased | Investigations | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10035528-Platelet count decreased | Investigations | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10047896-Weight gain | Investigations | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10047900-Weight loss | Investigations | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10049182-White blood cell decreased | Investigations | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10055599-Hemoglobin increased | Investigations | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10056910-GGT increased | Investigations | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10059895-Urine output decreased | Investigations | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10000486-Acidosis | Metabolism and nutrition disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10001680-Alkalosis | Metabolism and nutrition disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10002646-Anorexia | Metabolism and nutrition disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10020587-Hypercalcemia | Metabolism and nutrition disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10020639-Hyperglycemia | Metabolism and nutrition disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10020647-Hyperkalemia | Metabolism and nutrition disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10020670-Hypermagnesemia | Metabolism and nutrition disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10020680-Hypernatremia | Metabolism and nutrition disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10020870-Hypertriglyceridemia | Metabolism and nutrition disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10020943-Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10020949-Hypocalcemia | Metabolism and nutrition disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10021005-Hypoglycemia | Metabolism and nutrition disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10021018-Hypokalemia | Metabolism and nutrition disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10021028-Hypomagnesemia | Metabolism and nutrition disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10021038-Hyponatremia | Metabolism and nutrition disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10021059-Hypophosphatemia | Metabolism and nutrition disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Acidosis (metabolic or respiratory) | Metabolism and nutrition disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Alkaline phosphatase | Metabolism and nutrition disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Alkalosis (metabolic or respiratory) | Metabolism and nutrition disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Amylase | Metabolism and nutrition disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| AST, SGOT(serum glutamic oxaloacetic transaminase) | Metabolism and nutrition disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Bicarbonate, serum-low | Metabolism and nutrition disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Bilirubin (hyperbilirubinemia) | Metabolism and nutrition disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Calcium, serum-high (hypercalcemia) | Metabolism and nutrition disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Calcium, serum-low (hypocalcemia) | Metabolism and nutrition disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Cholesterol, serum-high (hypercholesteremia) | Metabolism and nutrition disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| CPK (creatine phosphokinase) | Metabolism and nutrition disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Creatinine | Metabolism and nutrition disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Glucose, serum-high (hyperglycemia) | Metabolism and nutrition disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Glucose, serum-low (hypoglycemia) | Metabolism and nutrition disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Lipase | Metabolism and nutrition disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Magnesium, serum-high (hypermagnesemia) | Metabolism and nutrition disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Magnesium, serum-low (hypomagnesemia) | Metabolism and nutrition disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Metabolic/Laboratory - Other (Specify, __) CARBON DIOXIDE | Metabolism and nutrition disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Metabolic/Laboratory - Other (Specify, __) HYPOVITAMINOSIS D | Metabolism and nutrition disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Metabolic/Laboratory - Other (Specify, __) HYPOGAMMAGLOBINEMIA | Metabolism and nutrition disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Metabolic/Laboratory - Other (Specify, __) HYPOGAMMAGLOBULINEMIA | Metabolism and nutrition disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Phosphate, serum-low (hypophosphatemia) | Metabolism and nutrition disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Potassium, serum-high (hyperkalemia) | Metabolism and nutrition disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Potassium, serum-low (hypokalemia) | Metabolism and nutrition disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Proteinuria | Metabolism and nutrition disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Sodium, serum-high (hypernatremia) | Metabolism and nutrition disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Sodium, serum-low (hyponatremia) | Metabolism and nutrition disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Triglyceride, serum-high (hypertriglyceridemia) | Metabolism and nutrition disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Uric acid, serum-high (hyperuricemia) | Metabolism and nutrition disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10003988-Back pain | Musculoskeletal and connective tissue disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10006002-Bone pain | Musculoskeletal and connective tissue disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10028411-Myalgia | Musculoskeletal and connective tissue disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10033425-Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Muscle weakness, generalized or specific area (not due to neuropathy) | Musculoskeletal and connective tissue disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10029104-Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10013573-Dizziness | Nervous system disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10013911-Dysgeusia | Nervous system disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10019211-Headache | Nervous system disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10020765-Hypersomnia | Nervous system disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10027175-Memory impairment | Nervous system disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10029205-Nervous system disorders - Other, specify | Nervous system disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10033987-Paresthesia | Nervous system disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10034620-Peripheral sensory neuropathy | Nervous system disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10041349-Somnolence | Nervous system disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10044565-Tremor | Nervous system disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Apnea | Nervous system disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Confusion | Nervous system disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Extrapyramidal/involuntary movement/restlessness | Nervous system disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Neurology - Other (Specify, __) DISORIENTED | Nervous system disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Neurology - Other (Specify, __) LETHARGY | Nervous system disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Neurology - Other (Specify, __) NUMBNESS (B) FEET | Nervous system disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Neurology - Other (Specify, __) PERIPHERAL NEUROP. | Nervous system disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Neurology - Other (Specify, __) RIGHT FACIAL NUMBNESS | Nervous system disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Neuropathy: motor | Nervous system disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Neuropathy: sensory | Nervous system disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Somnolence/depressed level of consciousness | Nervous system disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Syncope (fainting) | Nervous system disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10001497-Agitation | Psychiatric disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10002855-Anxiety | Psychiatric disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10010300-Confusion | Psychiatric disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10012260-Delusions | Psychiatric disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10012378-Depression | Psychiatric disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10019077-Hallucinations | Psychiatric disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10022437-Insomnia | Psychiatric disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10037175-Psychiatric disorders - Other, specify | Psychiatric disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10038743-Restlessness | Psychiatric disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Irritability (children <3 years of age) | Psychiatric disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Mood alteration | Psychiatric disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Neurology - Other (Specify, __) ALTERED MENTAL STATUS | Psychiatric disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Psychosis (hallucinations/delusions) | Psychiatric disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10046539-Urinary frequency | Renal and urinary disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10069339-Acute kidney injury | Renal and urinary disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Bladder Toxicity | Renal and urinary disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Cystitis | Renal and urinary disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Incontinence, urinary | Renal and urinary disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Renal Toxicity | Renal and urinary disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Renal/Genitourinary - Other (Specify, __) DYSURIA | Renal and urinary disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Renal/Genitourinary - Other (Specify, __) MILD RENAL INSUFFICIENCY | Renal and urinary disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Urinary frequency/urgency | Renal and urinary disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Urinary retention (including neurogenic bladder) | Renal and urinary disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Urine color change | Renal and urinary disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10046901-Vaginal discharge | Reproductive system and breast disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10046916-Vaginal inflammation | Reproductive system and breast disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10061339-Perineal pain | Reproductive system and breast disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Sexual/Reproductive Function - Other (Specify, __) VAGINAL ITCHING | Reproductive system and breast disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10011224-Cough | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10013963-Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10020201-Hoarseness | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10028735-Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10038695-Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10041367-Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10065746-Bronchopulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Adult Respiratory Distress Syndrome (ARDS) | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Bronchospasm, wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Hiccoughs (hiccups, singultus) | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Nasal cavity/paranasal sinus reactions | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Pleural effusion (non-malignant) | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Pneumonitis/pulmonary infiltrates | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Pulmonary Toxicity | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Pulmonary/Upper Respiratory - Other (Specify, __) BRONCHITIS | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Pulmonary/Upper Respiratory - Other (Specify, __) CHEST CONGESTION | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Pulmonary/Upper Respiratory - Other (Specify, __) NASAL DRIP | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Pulmonary/Upper Respiratory - Other (Specify, __) NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Pulmonary/Upper Respiratory - Other (Specify, __) NASAL DISCHARGE | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Pulmonary/Upper Respiratory - Other (Specify, __) TACHPNEIC | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Pulmonary/Upper Respiratory - Other (Specify, __) TACHYPNEIC | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Pulmonary/Upper Respiratory - Other (Specify, __) WEEZING | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Pulmonary/Upper Respiratory - Other (Specify, __) WHEEZING | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis) | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10001760-Alopecia | Skin and subcutaneous tissue disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10013786-Dry skin | Skin and subcutaneous tissue disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10015277-Erythroderma | Skin and subcutaneous tissue disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10033474-Pain of skin | Skin and subcutaneous tissue disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10037087-Pruritus | Skin and subcutaneous tissue disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10037847-Rash acneiform | Skin and subcutaneous tissue disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10037868-Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10040865-Skin hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10040868-Skin hypopigmentation | Skin and subcutaneous tissue disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10054524-Palmar-plantar erythrodysesthesia syndrome | Skin and subcutaneous tissue disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Bruising (in absence of Grade 3 or 4 thrombocytopenia) | Skin and subcutaneous tissue disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Dermatology/Skin - Other (Specify, __) ABRASION-LOWER THIGHS | Skin and subcutaneous tissue disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Dermatology/Skin - Other (Specify, __) ACTINIC KERATOSIS | Skin and subcutaneous tissue disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Dermatology/Skin - Other (Specify, __) BUMPS - BUTTOCK AREA | Skin and subcutaneous tissue disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Dermatology/Skin - Other (Specify, __) CONTUSION - HEAD | Skin and subcutaneous tissue disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Dermatology/Skin - Other (Specify, __) DARKNESS OF SKIN | Skin and subcutaneous tissue disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Dermatology/Skin - Other (Specify, __) FOLLICULITIS | Skin and subcutaneous tissue disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Dermatology/Skin - Other (Specify, __) ONYCHOLYSIS | Skin and subcutaneous tissue disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Dermatology/Skin - Other (Specify, __) PALE | Skin and subcutaneous tissue disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Dermatology/Skin - Other (Specify, __) PALLOR OF FACE | Skin and subcutaneous tissue disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Dermatology/Skin - Other (Specify, __) PEELING OF FINGERS | Skin and subcutaneous tissue disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Dermatology/Skin - Other (Specify, __) PEELING OF SKIN | Skin and subcutaneous tissue disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Dermatology/Skin - Other (Specify, __) SCALP LESIONS | Skin and subcutaneous tissue disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Dermatology/Skin - Other (Specify, __) SEBORRHEIC KERATOSIS | Skin and subcutaneous tissue disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Dermatology/Skin - Other (Specify, __) SKIN ERYTHEMA | Skin and subcutaneous tissue disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Dermatology/Skin - Other (Specify, __) SKIN PEELING | Skin and subcutaneous tissue disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Dermatology/Skin - Other (Specify, __) SKIN SENSITIVITY | Skin and subcutaneous tissue disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Dermatology/Skin - Other (Specify, __) SKIN TEAR RLQ | Skin and subcutaneous tissue disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Flushing | Skin and subcutaneous tissue disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Hair loss/alopecia (scalp or body) | Skin and subcutaneous tissue disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Hypopigmentation | Skin and subcutaneous tissue disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Injection site reaction/extravasation changes | Skin and subcutaneous tissue disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Pruritus/itching | Skin and subcutaneous tissue disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Rash/dermatitis associated with high-dose chemotherapy or BMT studies. | Skin and subcutaneous tissue disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Rash: acne/acneiform | Skin and subcutaneous tissue disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Rash: dermatitis associated with radiation | Skin and subcutaneous tissue disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Rash: erythema multiforme | Skin and subcutaneous tissue disorders | CTCAE 3.0 and 4.03 | Systematic Assessment | Rash: erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis) |
|
| Rash: hand-foot skin reaction | Skin and subcutaneous tissue disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Urticaria (hives, welts, wheals) | Skin and subcutaneous tissue disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10020772-Hypertension | Vascular disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| 10021097-Hypotension | Vascular disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Hematoma | Vascular disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Hemorrhage, GI | Vascular disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Hemorrhage, GU | Vascular disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Hemorrhage, pulmonary/upper respiratory | Vascular disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Hemorrhage/Bleeding - Other (Specify, __) RETINAL HEMORRHAGE | Vascular disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Hemorrhage/Bleeding - Other (Specify, __) RIGHT EYE | Vascular disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Hemorrhage/Bleeding - Other (Specify, __) RIGHT RETINAL HEMORRHAGE | Vascular disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Hemorrhage/bleeding associated with surgery, intra-operative or postoperative | Vascular disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Petechiae/purpura (hemorrhage/bleeding into skin or mucosa) | Vascular disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| PTT (Partial Thromboplastin Time) | Vascular disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Thrombosis/embolism (vascular access-related) | Vascular disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Thrombosis/thrombus/embolism | Vascular disorders | CTCAE 3.0 and 4.03 | Systematic Assessment |
| |
| Thrombotic microangiopathy | Vascular disorders | CTCAE 3.0 and 4.03 | Systematic Assessment | Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura [TTP] or hemolytic uremic syndrome [HUS]) |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anthony Stein, MD, corresponding author | Department of Hematology and Hematopoietic Cell Transplantation, City of Hope | 626-256-4673 | 62405 | astein@coh.org |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| D005047 | Etoposide |
| D036102 | Peripheral Blood Stem Cell Transplantation |
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D018380 | Hematopoietic Stem Cell Transplantation |
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Black, not of Hispanic origin |
|
| Hispanic |
|
| Other, Unknown |
|
| White |
|