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| ID | Type | Description | Link |
|---|---|---|---|
| U10CA031946 | U.S. NIH Grant/Contract | View source | |
| CALGB-10002 | |||
| CDR0000069354 | Registry Identifier | NCI Physician Data Query |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Monoclonal antibodies such as rituximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the numbers of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. Combining chemotherapy with rituximab and filgrastim may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combining rituximab with chemotherapy and filgrastim in treating patients who have Burkitt's lymphoma or Burkitt's leukemia.
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to disease (leukemia vs lymphoma).
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.
PROJECTED ACCRUAL: A total of 100 patients (50 per stratum) will be accrued for this study within 3 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rituximab with High Intensity Chemotherapy | Experimental | Cycle1: Cyclophosphamide 100 mg/m^2/day (d) IV (d 1-5), Prednisone 60 mg/m^2/d oral (d 1-7), Allopurinal 300 mg/d oral (d 1-14) Cycle 2, 4 & 6 (21 day): Ifosfamide 800 mg/m^2/d (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 25 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Cytarabine 1000 mg/m^2/d over 2 h (d 4-5), Etoposide 80 mg/m^2.d over 1 h (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 50 mg/m^2 d 8 cycle 2 only, 375 mg/m^2/d (d 10, 12 cycle 2, d 8 cycle 4 & 6) Cycle 3, 5 & 7 (21 day): Cyclophosphamide 200 mg/m^2/day (d) IV (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 50 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Doxorubicin 25 mg/m^2/d (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 375 mg/m^2/d (d 8) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| filgrastim | Biological | 5 ug/kg/day sub Q injection day 7 until ANC>5000/ul courses II-VII |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response Rate | Response is assessed by investigator according to Revised Response Criteria for Malignant Lymphoma. Complete response requires disappearance of all evidence of disease. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 2 Year Event Free Survival | Percentage of patients who were event free at 2 years. The 2-year event free rate was estimated using the Kaplan Meier method. An event is defined as death, progression or treatment failure. | 2 years |
| 2 Year Overall Survival |
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DISEASE CHARACTERISTICS:
Histologically, cytogenetically, or immunophenotypically confirmed Burkitt's leukemia or Burkitt's or Burkitt-like lymphoma
Previously untreated disease except hydroxyurea for leukocytosis
CNS involvement allowed
Patients with Burkitt's leukemia or Burkitt's lymphoma with bone marrow involvement must also be enrolled on CALGB-8461
Patients with Burkitt's leukemia must also be enrolled on CALGB-9665
PATIENT CHARACTERISTICS:
Age:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
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| Name | Affiliation | Role |
|---|---|---|
| David Rizzieri, MD | Duke University Medical Center Bone Marrow Transplant | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Naval Medical Center - San Diego | San Diego | California | 92134 | United States | ||
| Tunnell Cancer Center at Beebe Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24428673 | Result | Rizzieri DA, Johnson JL, Byrd JC, Lozanski G, Blum KA, Powell BL, Shea TC, Nattam S, Hoke E, Cheson BD, Larson RA; Alliance for Clinical Trials In Oncology (ACTION). Improved efficacy using rituximab and brief duration, high intensity chemotherapy with filgrastim support for Burkitt or aggressive lymphomas: cancer and Leukemia Group B study 10 002. Br J Haematol. 2014 Apr;165(1):102-11. doi: 10.1111/bjh.12736. Epub 2014 Jan 15. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rituximab With High Intensity Chemotherapy | Cycle1: Cyclophosphamide 100 mg/m^2/day (d) IV (d 1-5), Prednisone 60 mg/m^2/d oral (d 1-7), Allopurinal 300 mg/d oral (d 1-14) Cycle 2, 4 & 6 (21 day): Ifosfamide 800 mg/m^2/d (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 25 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Cytarabine 1000 mg/m^2/d over 2 h (d 4-5), Etoposide 80 mg/m^2.d over 1 h (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 50 mg/m^2 d 8 cycle 2 only, 375 mg/m^2/d (d 10, 12 cycle 2, d 8 cycle 4 & 6) Cycle 3, 5 & 7 (21 day): Cyclophosphamide 200 mg/m^2/day (d) IV (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 50 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Doxorubicin 25 mg/m^2/d (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 375 mg/m^2/d (d 8) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| rituximab | Biological | Day 8 course II 50 mg/sq m IV infusion: d 8 course IV & VI 375mg/sq m IV Day 10 course II: 325 mg/sq m IV infusion Day 12 course II: 375 mg/sq m IV infusion |
|
| cyclophosphamide | Drug | 200 mg/sq m/day IV infusion over 5-15 min days 1-5, courses I, III, V, VII |
|
| cytarabine | Drug | 1 g/sq m/day IV infusion Days 4 & 5, courses II, IV, VI |
|
| dexamethasone | Drug | 10mg/sq m PO or IV Days 1-5 courses II-VII |
|
| doxorubicin hydrochloride | Drug | 25 mg/sq m/day IV infusion Days 4 & 5 courses III,V, VII |
|
| etoposide | Drug | 80 mg/sq m/day IV infusion Days 4 & 5 courses II, IV, VI |
|
| ifosfamide | Drug | 800 mg/sq m/day IV infusion Days 1-5 courses II, IV, VI |
|
| leucovorin calcium | Drug | 25mg/sq m IV infusion over 15 min then 10 mg IV q 6 hrs until serum MTX <10nM, courses II-VII |
|
| methotrexate | Drug | 1.5 g/sq m IV infusion Day 1 courses II-VII |
|
| prednisone | Drug | 60 mg/sq m PO/day Days 1-7 course I |
|
| vincristine sulfate | Drug | 2 mg IV push Day 1 courses II-VII |
|
| Allopurinol | Drug | 300 mg/day PO Days 1-14, course I |
|
Percentage of participants who were alive at 2 years. The 2 year survival, with 95% confidence interval, was estimated using the Kaplan Meier method. |
| 2 years |
| Lewes |
| Delaware |
| 19958 |
| United States |
| CCOP - Christiana Care Health Services | Newark | Delaware | 19713 | United States |
| Walter Reed Army Medical Center | Washington D.C. | District of Columbia | 20307-5001 | United States |
| University of Illinois Cancer Center | Chicago | Illinois | 60612-7243 | United States |
| University of Chicago Cancer Research Center | Chicago | Illinois | 60637-1470 | United States |
| Fort Wayne Medical Oncology and Hematology | Fort Wayne | Indiana | 46845 | United States |
| Hematology Oncology Associates of the Quad Cities | Bettendorf | Iowa | 52722 | United States |
| Holden Comprehensive Cancer Center at University of Iowa | Iowa City | Iowa | 52242-1002 | United States |
| Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| Union Hospital Cancer Program at Union Hospital | Elkton | Maryland | 21921 | United States |
| Masonic Cancer Center at University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia | Missouri | 65203 | United States |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756-0002 | United States |
| Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees Township | New Jersey | 08043 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | United States |
| Monter Cancer Center of the North Shore-LIJ Health System | Lake Success | New York | 11042 | United States |
| CCOP - North Shore University Hospital | Manhasset | New York | 11030 | United States |
| Don Monti Comprehensive Cancer Center at North Shore University Hospital | Manhasset | New York | 11030 | United States |
| Long Island Jewish Medical Center | New Hyde Park | New York | 11040 | United States |
| Stony Brook University Cancer Center | Stony Brook | New York | 11794-9446 | United States |
| Presbyterian Cancer Center at Presbyterian Hospital | Charlotte | North Carolina | 28233-3549 | United States |
| Duke Comprehensive Cancer Center | Durham | North Carolina | 27710 | United States |
| Wayne Memorial Hospital, Incorporated | Goldsboro | North Carolina | 27534 | United States |
| Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157-1096 | United States |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus | Ohio | 43210-1240 | United States |
| Rhode Island Hospital Comprehensive Cancer Center | Providence | Rhode Island | 02903 | United States |
| Miriam Hospital | Providence | Rhode Island | 02906 | United States |
| Mountainview Medical | Berlin Corners | Vermont | 05602 | United States |
| Fletcher Allen Health Care - University Health Center Campus | Burlington | Vermont | 05401 | United States |
| Virginia Commonwealth University Massey Cancer Center | Richmond | Virginia | 23298-0037 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Rituximab With High Intensity Chemotherapy | Cycle1: Cyclophosphamide 100 mg/m^2/day (d) IV (d 1-5), Prednisone 60 mg/m^2/d oral (d 1-7), Allopurinal 300 mg/d oral (d 1-14) Cycle 2, 4 & 6 (21 day): Ifosfamide 800 mg/m^2/d (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 25 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Cytarabine 1000 mg/m^2/d over 2 h (d 4-5), Etoposide 80 mg/m^2.d over 1 h (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 50 mg/m^2 d 8 cycle 2 only, 375 mg/m^2/d (d 10, 12 cycle 2, d 8 cycle 4 & 6) Cycle 3, 5 & 7 (21 day): Cyclophosphamide 200 mg/m^2/day (d) IV (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 50 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Doxorubicin 25 mg/m^2/d (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 375 mg/m^2/d (d 8) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | 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 | Complete Response Rate | Response is assessed by investigator according to Revised Response Criteria for Malignant Lymphoma. Complete response requires disappearance of all evidence of disease. | Posted | Number | 95% Confidence Interval | percentage of participants | 6 months |
|
|
| ||||||||||||||||||||||||||
| Secondary | 2 Year Event Free Survival | Percentage of patients who were event free at 2 years. The 2-year event free rate was estimated using the Kaplan Meier method. An event is defined as death, progression or treatment failure. | Posted | Number | 95% Confidence Interval | percentage of participants | 2 years |
|
| |||||||||||||||||||||||||||
| Secondary | 2 Year Overall Survival | Percentage of participants who were alive at 2 years. The 2 year survival, with 95% confidence interval, was estimated using the Kaplan Meier method. | Posted | Number | 95% Confidence Interval | percentage of participants | 2 years |
|
|
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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 | Rituximab With High Intensity Chemotherapy | Cycle1: Cyclophosphamide 100 mg/m^2/day (d) IV (d 1-5), Prednisone 60 mg/m^2/d oral (d 1-7), Allopurinal 300 mg/d oral (d 1-14) Cycle 2, 4 & 6 (21 day): Ifosfamide 800 mg/m^2/d (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 25 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Cytarabine 1000 mg/m^2/d over 2 h (d 4-5), Etoposide 80 mg/m^2.d over 1 h (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 50 mg/m^2 d 8 cycle 2 only, 375 mg/m^2/d (d 10, 12 cycle 2, d 8 cycle 4 & 6) Cycle 3, 5 & 7 (21 day): Cyclophosphamide 200 mg/m^2/day (d) IV (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 50 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Doxorubicin 25 mg/m^2/d (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 375 mg/m^2/d (d 8) | 61 | 105 | 101 | 105 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 5 | Systematic Assessment |
| |
| Hemoglobin decreased | Blood and lymphatic system disorders | MedDRA 5 | Systematic Assessment |
| |
| Lymphatic disorder | Blood and lymphatic system disorders | MedDRA 5 | Systematic Assessment |
| |
| Lymphatics | Blood and lymphatic system disorders | MedDRA 5 | Systematic Assessment |
| |
| Transfusion: Platelets | Blood and lymphatic system disorders | MedDRA 5 | Systematic Assessment |
| |
| Transfusion: pRBCs | Blood and lymphatic system disorders | MedDRA 5 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 5 | Systematic Assessment |
| |
| Arrhythmia supraventricular | Cardiac disorders | MedDRA 5 | Systematic Assessment |
| |
| Cardiac disorder | Cardiac disorders | MedDRA 5 | Systematic Assessment |
| |
| Conduction disorder | Cardiac disorders | MedDRA 5 | Systematic Assessment |
| |
| Edema | Cardiac disorders | MedDRA 5 | Systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | MedDRA 5 | Systematic Assessment |
| |
| Myocardial ischemia | Cardiac disorders | MedDRA 5 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA 5 | Systematic Assessment |
| |
| Nodal arrhythmia | Cardiac disorders | MedDRA 5 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 5 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 5 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 5 | Systematic Assessment |
| |
| Ventricular arrhythmia | Cardiac disorders | MedDRA 5 | Systematic Assessment |
| |
| Ear disorder | Ear and labyrinth disorders | MedDRA 5 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 5 | Systematic Assessment |
| |
| Cushingoid | Endocrine disorders | MedDRA 5 | Systematic Assessment |
| |
| Eye disorder | Eye disorders | MedDRA 5 | Systematic Assessment |
| |
| Photophobia | Eye disorders | MedDRA 5 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 5 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Anal pain | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Gingival pain | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Hematemesis | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Melena/GI bleeding | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Rectal bleeding/hematochezia | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Rectal pain | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Typhlitis | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 5 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 5 | Systematic Assessment |
| |
| Edema limbs | General disorders | MedDRA 5 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 5 | Systematic Assessment |
| |
| Fever | General disorders | MedDRA 5 | Systematic Assessment |
| |
| General symptom | General disorders | MedDRA 5 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 5 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 5 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA 5 | Systematic Assessment |
| |
| Hepatobiliary disease | Hepatobiliary disorders | MedDRA 5 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 5 | Systematic Assessment |
| |
| Anal infection | Infections and infestations | MedDRA 5 | Systematic Assessment |
| |
| Catheter related infection | Infections and infestations | MedDRA 5 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 5 | Systematic Assessment |
| |
| Infection with grade 3 or 4 neutropenia | Infections and infestations | MedDRA 5 | Systematic Assessment |
| |
| Infection with unknown ANC | Infections and infestations | MedDRA 5 | Systematic Assessment |
| |
| Infection without neutropenia | Infections and infestations | MedDRA 5 | Systematic Assessment |
| |
| Infectious colitis | Infections and infestations | MedDRA 5 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 5 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 5 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 5 | Systematic Assessment |
| |
| Wound-infectious | Infections and infestations | MedDRA 5 | Systematic Assessment |
| |
| Dermatitis radiation | Injury, poisoning and procedural complications | MedDRA 5 | Systematic Assessment |
| |
| Vascular access complication | Injury, poisoning and procedural complications | MedDRA 5 | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA 5 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 5 | Systematic Assessment |
| |
| Alkaline phosphatase | Investigations | MedDRA 5 | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | MedDRA 5 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 5 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 5 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 5 | Systematic Assessment |
| |
| Cardiac troponin I increased | Investigations | MedDRA 5 | Systematic Assessment |
| |
| Coagulopathy | Investigations | MedDRA 5 | Systematic Assessment |
| |
| Creatinine increased | Investigations | MedDRA 5 | Systematic Assessment |
| |
| INR increased | Investigations | MedDRA 5 | Systematic Assessment |
| |
| Laboratory test abnormal | Investigations | MedDRA 5 | Systematic Assessment |
| |
| Leukocyte count decreased | Investigations | MedDRA 5 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 5 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 5 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 5 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 5 | Systematic Assessment |
| |
| Weight gain | Investigations | MedDRA 5 | Systematic Assessment |
| |
| Weight loss | Investigations | MedDRA 5 | Systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | MedDRA 5 | Systematic Assessment |
| |
| Alkalosis | Metabolism and nutrition disorders | MedDRA 5 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 5 | Systematic Assessment |
| |
| Blood glucose increased | Metabolism and nutrition disorders | MedDRA 5 | Systematic Assessment |
| |
| Blood uric acid increased | Metabolism and nutrition disorders | MedDRA 5 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 5 | Systematic Assessment |
| |
| Serum albumin decreased | Metabolism and nutrition disorders | MedDRA 5 | Systematic Assessment |
| |
| Serum calcium decreased | Metabolism and nutrition disorders | MedDRA 5 | Systematic Assessment |
| |
| Serum calcium increased | Metabolism and nutrition disorders | MedDRA 5 | Systematic Assessment |
| |
| Serum glucose decreased | Metabolism and nutrition disorders | MedDRA 5 | Systematic Assessment |
| |
| Serum magnesium decreased | Metabolism and nutrition disorders | MedDRA 5 | Systematic Assessment |
| |
| Serum magnesium increased | Metabolism and nutrition disorders | MedDRA 5 | Systematic Assessment |
| |
| Serum phosphate decreased | Metabolism and nutrition disorders | MedDRA 5 | Systematic Assessment |
| |
| Serum potassium decreased | Metabolism and nutrition disorders | MedDRA 5 | Systematic Assessment |
| |
| Serum potassium increased | Metabolism and nutrition disorders | MedDRA 5 | Systematic Assessment |
| |
| Serum sodium decreased | Metabolism and nutrition disorders | MedDRA 5 | Systematic Assessment |
| |
| Serum sodium increased | Metabolism and nutrition disorders | MedDRA 5 | Systematic Assessment |
| |
| Tumor lysis syndrome | Metabolism and nutrition disorders | MedDRA 5 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 5 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 5 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 5 | Systematic Assessment |
| |
| Chest wall pain | Musculoskeletal and connective tissue disorders | MedDRA 5 | Systematic Assessment |
| |
| Muscle weakness | Musculoskeletal and connective tissue disorders | MedDRA 5 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 5 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 5 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 5 | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA 5 | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA 5 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 5 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 5 | Systematic Assessment |
| |
| Extrapyramidal disorder | Nervous system disorders | MedDRA 5 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 5 | Systematic Assessment |
| |
| Intracranial hemorrhage | Nervous system disorders | MedDRA 5 | Systematic Assessment |
| |
| Ischemia cerebrovascular | Nervous system disorders | MedDRA 5 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA 5 | Systematic Assessment |
| |
| Neurological disorder NOS | Nervous system disorders | MedDRA 5 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 5 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 5 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 5 | Systematic Assessment |
| |
| Speech disorder | Nervous system disorders | MedDRA 5 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 5 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 5 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 5 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 5 | Systematic Assessment |
| |
| Confusion | Psychiatric disorders | MedDRA 5 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 5 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 5 | Systematic Assessment |
| |
| Personality change | Psychiatric disorders | MedDRA 5 | Systematic Assessment |
| |
| Psychosis | Psychiatric disorders | MedDRA 5 | Systematic Assessment |
| |
| Bladder pain | Renal and urinary disorders | MedDRA 5 | Systematic Assessment |
| |
| Dysuria (painful urination) | Renal and urinary disorders | MedDRA 5 | Systematic Assessment |
| |
| Hematuria (in the absence of vaginal bleeding) | Renal and urinary disorders | MedDRA 5 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 5 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 5 | Systematic Assessment |
| |
| Urethral fistula | Renal and urinary disorders | MedDRA 5 | Systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | MedDRA 5 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 5 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 5 | Systematic Assessment |
| |
| Urogenital disorder | Renal and urinary disorders | MedDRA 5 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA 5 | Systematic Assessment |
| |
| Adult respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Hemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Tracheal stenosis | Respiratory, thoracic and mediastinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 5 | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 5 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 5 | Systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA 5 | Systematic Assessment |
| |
| Hand-and-foot syndrome | Skin and subcutaneous tissue disorders | MedDRA 5 | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 5 | Systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA 5 | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 5 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 5 | Systematic Assessment |
| |
| Rash desquamating | Skin and subcutaneous tissue disorders | MedDRA 5 | Systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA 5 | Systematic Assessment |
| |
| Skin ulceration | Skin and subcutaneous tissue disorders | MedDRA 5 | Systematic Assessment |
| |
| Sweating | Skin and subcutaneous tissue disorders | MedDRA 5 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 5 | Systematic Assessment |
| |
| Hemorrhage | Vascular disorders | MedDRA 5 | Systematic Assessment |
| |
| Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia | Vascular disorders | MedDRA 5 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 5 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 5 | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA 5 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 5 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood disorder | Blood and lymphatic system disorders | MedDRA 5 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 5 | Systematic Assessment |
| |
| Hemoglobin decreased | Blood and lymphatic system disorders | MedDRA 5 | Systematic Assessment |
| |
| Lymphatic disorder | Blood and lymphatic system disorders | MedDRA 5 | Systematic Assessment |
| |
| Transfusion: Platelets | Blood and lymphatic system disorders | MedDRA 5 | Systematic Assessment |
| |
| Transfusion: pRBCs | Blood and lymphatic system disorders | MedDRA 5 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 5 | Systematic Assessment |
| |
| Arrhythmia supraventricular | Cardiac disorders | MedDRA 5 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 5 | Systematic Assessment |
| |
| Cardiac disorder | Cardiac disorders | MedDRA 5 | Systematic Assessment |
| |
| Edema | Cardiac disorders | MedDRA 5 | Systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | MedDRA 5 | Systematic Assessment |
| |
| Myocardial ischemia | Cardiac disorders | MedDRA 5 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 5 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 5 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 5 | Systematic Assessment |
| |
| Ear disorder | Ear and labyrinth disorders | MedDRA 5 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 5 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 5 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 5 | Systematic Assessment |
| |
| Endocrine disorder | Endocrine disorders | MedDRA 5 | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 5 | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA 5 | Systematic Assessment |
| |
| Dry eye syndrome | Eye disorders | MedDRA 5 | Systematic Assessment |
| |
| Eye disorder | Eye disorders | MedDRA 5 | Systematic Assessment |
| |
| Flashing vision | Eye disorders | MedDRA 5 | Systematic Assessment |
| |
| Photophobia | Eye disorders | MedDRA 5 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 5 | Systematic Assessment |
| |
| Watering eyes | Eye disorders | MedDRA 5 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Anal pain | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Ear, nose and throat examination abnormal | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Esophageal pain | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Fecal incontinence | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Melena/GI bleeding | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Rectal bleeding/hematochezia | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Rectal hemorrhage | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Rectal pain | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 5 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 5 | Systematic Assessment |
| |
| Edema limbs | General disorders | MedDRA 5 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 5 | Systematic Assessment |
| |
| Fever | General disorders | MedDRA 5 | Systematic Assessment |
| |
| General symptom | General disorders | MedDRA 5 | Systematic Assessment |
| |
| Ill-defined disorder | General disorders | MedDRA 5 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 5 | Systematic Assessment |
| |
| Localized edema | General disorders | MedDRA 5 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 5 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 5 | Systematic Assessment |
| |
| Hepatobiliary disease | Hepatobiliary disorders | MedDRA 5 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 5 | Systematic Assessment |
| |
| Immune system disorder | Immune system disorders | MedDRA 5 | Systematic Assessment |
| |
| Abdominal infection | Infections and infestations | MedDRA 5 | Systematic Assessment |
| |
| Anorectal infection | Infections and infestations | MedDRA 5 | Systematic Assessment |
| |
| Catheter related infection | Infections and infestations | MedDRA 5 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 5 | Systematic Assessment |
| |
| Infection with grade 3 or 4 neutropenia | Infections and infestations | MedDRA 5 | Systematic Assessment |
| |
| Infection with unknown ANC | Infections and infestations | MedDRA 5 | Systematic Assessment |
| |
| Infection without neutropenia | Infections and infestations | MedDRA 5 | Systematic Assessment |
| |
| Mucosal infection | Infections and infestations | MedDRA 5 | Systematic Assessment |
| |
| Opportunistic infection | Infections and infestations | MedDRA 5 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 5 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 5 | Systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | MedDRA 5 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 5 | Systematic Assessment |
| |
| Wound-infectious | Infections and infestations | MedDRA 5 | Systematic Assessment |
| |
| Bruising | Injury, poisoning and procedural complications | MedDRA 5 | Systematic Assessment |
| |
| Operative injury to bladder and/or ureter | Injury, poisoning and procedural complications | MedDRA 5 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 5 | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA 5 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 5 | Systematic Assessment |
| |
| Alkaline phosphatase | Investigations | MedDRA 5 | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | MedDRA 5 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 5 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 5 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 5 | Systematic Assessment |
| |
| Coagulopathy | Investigations | MedDRA 5 | Systematic Assessment |
| |
| Creatine phosphokinase increased | Investigations | MedDRA 5 | Systematic Assessment |
| |
| Creatinine increased | Investigations | MedDRA 5 | Systematic Assessment |
| |
| Electrocardiogram QTc interval prolonged | Investigations | MedDRA 5 | Systematic Assessment |
| |
| Fibrinogen decreased | Investigations | MedDRA 5 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 5 | Systematic Assessment |
| |
| INR increased | Investigations | MedDRA 5 | Systematic Assessment |
| |
| Laboratory test abnormal | Investigations | MedDRA 5 | Systematic Assessment |
| |
| Leukocyte count decreased | Investigations | MedDRA 5 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 5 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 5 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 5 | Systematic Assessment |
| |
| Serum cholesterol increased | Investigations | MedDRA 5 | Systematic Assessment |
| |
| Weight gain | Investigations | MedDRA 5 | Systematic Assessment |
| |
| Weight loss | Investigations | MedDRA 5 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 5 | Systematic Assessment |
| |
| Blood bicarbonate decreased | Metabolism and nutrition disorders | MedDRA 5 | Systematic Assessment |
| |
| Blood glucose increased | Metabolism and nutrition disorders | MedDRA 5 | Systematic Assessment |
| |
| Blood uric acid increased | Metabolism and nutrition disorders | MedDRA 5 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 5 | Systematic Assessment |
| |
| Iron overload | Metabolism and nutrition disorders | MedDRA 5 | Systematic Assessment |
| |
| Serum albumin decreased | Metabolism and nutrition disorders | MedDRA 5 | Systematic Assessment |
| |
| Serum calcium decreased | Metabolism and nutrition disorders | MedDRA 5 | Systematic Assessment |
| |
| Serum calcium increased | Metabolism and nutrition disorders | MedDRA 5 | Systematic Assessment |
| |
| Serum glucose decreased | Metabolism and nutrition disorders | MedDRA 5 | Systematic Assessment |
| |
| Serum magnesium decreased | Metabolism and nutrition disorders | MedDRA 5 | Systematic Assessment |
| |
| Serum magnesium increased | Metabolism and nutrition disorders | MedDRA 5 | Systematic Assessment |
| |
| Serum phosphate decreased | Metabolism and nutrition disorders | MedDRA 5 | Systematic Assessment |
| |
| Serum potassium decreased | Metabolism and nutrition disorders | MedDRA 5 | Systematic Assessment |
| |
| Serum potassium increased | Metabolism and nutrition disorders | MedDRA 5 | Systematic Assessment |
| |
| Serum sodium decreased | Metabolism and nutrition disorders | MedDRA 5 | Systematic Assessment |
| |
| Serum sodium increased | Metabolism and nutrition disorders | MedDRA 5 | Systematic Assessment |
| |
| Serum triglycerides increased | Metabolism and nutrition disorders | MedDRA 5 | Systematic Assessment |
| |
| Tumor lysis syndrome | Metabolism and nutrition disorders | MedDRA 5 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 5 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 5 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 5 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 5 | Systematic Assessment |
| |
| Buttock pain | Musculoskeletal and connective tissue disorders | MedDRA 5 | Systematic Assessment |
| |
| Chest wall pain | Musculoskeletal and connective tissue disorders | MedDRA 5 | Systematic Assessment |
| |
| Muscle weakness | Musculoskeletal and connective tissue disorders | MedDRA 5 | Systematic Assessment |
| |
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | MedDRA 5 | Systematic Assessment |
| |
| Musculoskeletal disorder | Musculoskeletal and connective tissue disorders | MedDRA 5 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 5 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 5 | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 5 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 5 | Systematic Assessment |
| |
| Treatment related secondary malignancy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 5 | Systematic Assessment |
| |
| Tumor pain (onset or exacerbation of tumor pain due to treatment) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 5 | Systematic Assessment |
| |
| Arachnoiditis | Nervous system disorders | MedDRA 5 | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA 5 | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA 5 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 5 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 5 | Systematic Assessment |
| |
| Extrapyramidal disorder | Nervous system disorders | MedDRA 5 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 5 | Systematic Assessment |
| |
| Intracranial hemorrhage | Nervous system disorders | MedDRA 5 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA 5 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA 5 | Systematic Assessment |
| |
| Neurological disorder NOS | Nervous system disorders | MedDRA 5 | Systematic Assessment |
| |
| Neuropathy - cranial | Nervous system disorders | MedDRA 5 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 5 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 5 | Systematic Assessment |
| |
| Pyramidal tract syndrome | Nervous system disorders | MedDRA 5 | Systematic Assessment |
| |
| Sense of smell | Nervous system disorders | MedDRA 5 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 5 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 5 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 5 | Systematic Assessment |
| |
| Confusion | Psychiatric disorders | MedDRA 5 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 5 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 5 | Systematic Assessment |
| |
| Libido decreased | Psychiatric disorders | MedDRA 5 | Systematic Assessment |
| |
| Personality change | Psychiatric disorders | MedDRA 5 | Systematic Assessment |
| |
| Psychosis | Psychiatric disorders | MedDRA 5 | Systematic Assessment |
| |
| Bladder hemorrhage | Renal and urinary disorders | MedDRA 5 | Systematic Assessment |
| |
| Bladder pain | Renal and urinary disorders | MedDRA 5 | Systematic Assessment |
| |
| Bladder spasm | Renal and urinary disorders | MedDRA 5 | Systematic Assessment |
| |
| Dysuria (painful urination) | Renal and urinary disorders | MedDRA 5 | Systematic Assessment |
| |
| Hematuria (in the absence of vaginal bleeding) | Renal and urinary disorders | MedDRA 5 | Systematic Assessment |
| |
| Incontinence | Renal and urinary disorders | MedDRA 5 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 5 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 5 | Systematic Assessment |
| |
| Ureteric obstruction | Renal and urinary disorders | MedDRA 5 | Systematic Assessment |
| |
| Urethral pain | Renal and urinary disorders | MedDRA 5 | Systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | MedDRA 5 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 5 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 5 | Systematic Assessment |
| |
| Urogenital disorder | Renal and urinary disorders | MedDRA 5 | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 5 | Systematic Assessment |
| |
| Gynecomastia | Reproductive system and breast disorders | MedDRA 5 | Systematic Assessment |
| |
| Irregular menstruation | Reproductive system and breast disorders | MedDRA 5 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA 5 | Systematic Assessment |
| |
| Reproductive tract disorder | Reproductive system and breast disorders | MedDRA 5 | Systematic Assessment |
| |
| Vaginal dryness | Reproductive system and breast disorders | MedDRA 5 | Systematic Assessment |
| |
| Vaginal hemorrhage | Reproductive system and breast disorders | MedDRA 5 | Systematic Assessment |
| |
| Vaginal inflammation | Reproductive system and breast disorders | MedDRA 5 | Systematic Assessment |
| |
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Hemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Laryngeal edema | Respiratory, thoracic and mediastinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Laryngoscopy abnormal | Respiratory, thoracic and mediastinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Respiratory tract hemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Voice alteration | Respiratory, thoracic and mediastinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 5 | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 5 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 5 | Systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA 5 | Systematic Assessment |
| |
| Hand-and-foot syndrome | Skin and subcutaneous tissue disorders | MedDRA 5 | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 5 | Systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA 5 | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 5 | Systematic Assessment |
| |
| Pigmentation changes (e.g., vitiligo) | Skin and subcutaneous tissue disorders | MedDRA 5 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 5 | Systematic Assessment |
| |
| Rash acneiform | Skin and subcutaneous tissue disorders | MedDRA 5 | Systematic Assessment |
| |
| Rash desquamating | Skin and subcutaneous tissue disorders | MedDRA 5 | Systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA 5 | Systematic Assessment |
| |
| Skin induration | Skin and subcutaneous tissue disorders | MedDRA 5 | Systematic Assessment |
| |
| Skin ulceration | Skin and subcutaneous tissue disorders | MedDRA 5 | Systematic Assessment |
| |
| Sweating | Skin and subcutaneous tissue disorders | MedDRA 5 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 5 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 5 | Systematic Assessment |
| |
| Hemorrhage | Vascular disorders | MedDRA 5 | Systematic Assessment |
| |
| Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia | Vascular disorders | MedDRA 5 | Systematic Assessment |
| |
| Hot flashes | Vascular disorders | MedDRA 5 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 5 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 5 | Systematic Assessment |
| |
| Lymphedema | Vascular disorders | MedDRA 5 | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA 5 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 5 | Systematic Assessment |
|
Must obtain prior Sponsor approval
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Rizzieri, M.D. | Duke University Medical Center | rizzi003@dm.duke.edu |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D002051 | Burkitt Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069585 | Filgrastim |
| D000069283 | Rituximab |
| D003520 | Cyclophosphamide |
| D003561 | Cytarabine |
| D003907 | Dexamethasone |
| D004317 | Doxorubicin |
| D005047 | Etoposide |
| D007069 | Ifosfamide |
| D002955 | Leucovorin |
| D008727 | Methotrexate |
| D011241 | Prednisone |
| D014750 | Vincristine |
| D000493 | Allopurinol |
| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| 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 |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D005960 | Glucosides |
| D010078 | Oxazines |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D000630 | Aminopterin |
| D011244 | Pregnadienediols |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D011687 | Purines |
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|