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| ID | Type | Description | Link |
|---|---|---|---|
| U10CA031946 | U.S. NIH Grant/Contract | View source | |
| CALGB-50701 | |||
| CDR0000572604 | 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 epratuzumab and rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving epratuzumab and rituximab together may be more effective in treating follicular non-Hodgkin lymphoma.
PURPOSE: This phase II trial is studying how well giving epratuzumab together with rituximab works in treating patients with previously untreated follicular non-Hodgkin lymphoma.
OBJECTIVES:
Primary
Secondary
OUTLINE:
Patients receive fludeoxyglucose F 18 (FDG) subcutaneously and undergo positron emission tomography at baseline and after induction therapy to assess the degree of FDG uptake.
After completion of study treatment, patients are followed every 4 months for 2 years then every 6 months for up to 10 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epratuzumab Plus Rituximab | Experimental | Induction Therapy (Month 1): Epratuzumab 360 mg/m^2 by IV days 1, 8, 15 & 22; Rituximab 375 mg/m^2 by IV day 3, 8, 15 & 22 Extended Induction (Weeks 12, 20, 28 & 36) Epratuzumab 360 mg/m^2 by IV weeks 12, 20, 28 & 36; Rituximab 375 mg/m^2 by IV weeks 12, 20, 28 & 36 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| epratuzumab | Biological | Days 1, 8, 15, 22 and weeks 12, 20, 28, & 36: 360mg/sq m IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Overall Response | Overall response is defined as achievement of a complete response (CR) or partial response (PR) as defined by the Revised Response Criteria for Malignant Lymphoma. CR: complete disappearance of all detectable disease PR: >=50% decrease in the sum of the product of diameters of indicator lesions | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | Progression free survival (PFS) was defined as the time from registration to progression or death of any cause. Progression free and alive patients were censored at the date of last follow-up. The median PFS with 95% CI was estimated using the Kaplan Meier method. | Duration of study (up to 10 years) |
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DISEASE CHARACTERISTICS:
Histologically* confirmed follicular non-Hodgkin lymphoma (NHL)
Confirmed CD20 antigen expression by flow cytometry or immunohistochemistry
Measurable disease by physical examination or imaging studies
Any tumor mass > 1 cm is acceptable
No nonmeasurable disease only, including any of the following:
No known CNS involvement by lymphoma
Required to participate in companion FDG-PET imaging study CALGB 580701
PATIENT CHARACTERISTICS:
ECOG performance status ≤ 2
Absolute neutrophil count ≥ 1,000/μL
Platelet count ≥ 50,000/μL
Patients with HIV infection are eligible provided they meet the following criteria:
Not pregnant or nursing
Fertile patients must use effective contraception during and for 3 months after completion of study therapy
No known Human Anti-Chimeric Antibody (HACA)-positivity
PRIOR CONCURRENT THERAPY:
No prior therapy for NHL including chemotherapy, radiotherapy, or immunotherapy (e.g., monoclonal antibody-based therapy)
More than 2 weeks since prior corticosteroids except for maintenance therapy for non-malignant disease
No concurrent dexamethasone or other steroids as antiemetics except for the following circumstances:
No concurrent hormonal therapy except steroids for adrenal failure OR hormones for non-disease-related conditions (e.g., insulin for diabetes)
No other concurrent chemotherapeutic agents
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| Name | Affiliation | Role |
|---|---|---|
| Barbara Grant, MD | University of Vermont | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Medical Office -Vandever Medical Office | San Diego | California | 92120 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23922187 | Result | Grant BW, Jung SH, Johnson JL, Kostakoglu L, Hsi E, Byrd JC, Jones J, Leonard JP, Martin SE, Cheson BD. A phase 2 trial of extended induction epratuzumab and rituximab for previously untreated follicular lymphoma: CALGB 50701. Cancer. 2013 Nov 1;119(21):3797-804. doi: 10.1002/cncr.28299. Epub 2013 Aug 6. | |
| 35787017 | Derived | Rutherford SC, Yin J, Pederson L, Perez Burbano G, LaPlant B, Shadman M, Li H, LeBlanc ML, Kenkre VP, Hong F, Blum KA, Dockter T, Martin P, Jung SH, Grant B, Rosenbaum C, Ujjani C, Barr PM, Unger JM, Cheson BD, Bartlett NL, Kahl B, Friedberg JW, Mandrekar SJ, Leonard JP. Relevance of Bone Marrow Biopsies for Response Assessment in US National Cancer Institute National Clinical Trials Network Follicular Lymphoma Clinical Trials. J Clin Oncol. 2023 Jan 10;41(2):336-342. doi: 10.1200/JCO.21.02301. Epub 2022 Jul 5. |
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One participant was deemed ineligible and excluded from all analyses per study design.
Between March 2008 and July 2009, 60 participants were recruited.
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| ID | Title | Description |
|---|---|---|
| FG000 | Epratuzumab Plus Rituximab | Induction Therapy (Month 1): Epratuzumab 360 mg/m^2 by IV days 1, 8, 15 & 22; Rituximab 375 mg/m^2 by IV day 3, 8, 15 & 22 Extended Induction (Weeks 12, 20, 28 & 36) Epratuzumab 360 mg/m^2 by IV weeks 12, 20, 28 & 36; Rituximab 375 mg/m^2 by IV weeks 12, 20, 28 & 36 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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| rituximab | Biological | Day 3, 8, 15, 22 and weeks 12, 20, 28, & 36: 375mg/sq m IV |
|
| UCSF Helen Diller Family Comprehensive Cancer Center |
| San Francisco |
| California |
| 94115 |
| United States |
| Middlesex Hospital Cancer Center | Middletown | Connecticut | 06457 | United States |
| Tunnell Cancer Center at Beebe Medical Center | Lewes | Delaware | 19958 | United States |
| CCOP - Christiana Care Health Services | Newark | Delaware | 19713 | United States |
| Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | 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 |
| Elkhart General Hospital | Elkhart | Indiana | 46515 | United States |
| Fort Wayne Medical Oncology and Hematology | Fort Wayne | Indiana | 46845 | United States |
| Howard Community Hospital | Kokomo | Indiana | 46904 | United States |
| Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte | Indiana | 46350 | United States |
| CCOP - Northern Indiana CR Consortium | South Bend | Indiana | 46601 | United States |
| Memorial Hospital of South Bend | South Bend | Indiana | 46601 | United States |
| Saint Joseph Regional Medical Center | South Bend | Indiana | 46617 | United States |
| South Bend Clinic | South Bend | Indiana | 46617 | United States |
| Hematology Oncology Associates of the Quad Cities | Bettendorf | Iowa | 52722 | United States |
| Union Hospital Cancer Program at Union Hospital | Elkton MD | Maryland | 21921 | United States |
| Dana-Farber/Brigham and Women's Cancer Center | Boston | Massachusetts | 02115 | United States |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| Lakeland Regional Cancer Care Center - St. Joseph | Saint Joseph | Michigan | 49085 | United States |
| Oncology Care Associates, PLLC | Saint Joseph | Michigan | 49085 | United States |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia | Missouri | 65203 | United States |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St Louis | Missouri | 63110 | United States |
| New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care | Concord | New Hampshire | 03301 | United States |
| New Hampshire Oncology - Hematology, PA - Hooksett | Hooksett | New Hampshire | 03106 | United States |
| Lakes Region General Hospital | Laconia | New Hampshire | 03246 | 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 |
| CCOP - Hematology-Oncology Associates of Central New York | East Syracuse | New York | 13057 | United States |
| New York Weill Cornell Cancer Center at Cornell University | New York | New York | 10021 | United States |
| Wayne Memorial Hospital, Incorporated | Goldsboro | North Carolina | 27534 | United States |
| Kinston Medical Specialists | Kinston | North Carolina | 28501 | United States |
| Iredell Memorial Hospital | Statesville | North Carolina | 28677 | 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 |
| Mountainview Medical | Berlin Corners | Vermont | 05602 | United States |
| Fletcher Allen Health Care - University Health Center Campus | Burlington | Vermont | 05401 | United States |
| Danville Regional Medical Center | Danville | Virginia | 24541 | United States |
| Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County | Martinsville | Virginia | 24115 | United States |
| Virginia Commonwealth University Massey Cancer Center | Richmond | Virginia | 23298-0037 | United States |
| St. Mary's Regional Cancer Center at St. Mary's Medical Center | Huntington | West Virginia | 25702 | United States |
| 30575311 | Derived | Lansigan F, Barak I, Pitcher B, Jung SH, Cheson BD, Czuczman M, Martin P, Hsi E, Schoder H, Smith S, Bartlett NL, Leonard JP, Blum KA. The prognostic significance of PFS24 in follicular lymphoma following firstline immunotherapy: A combined analysis of 3 CALGB trials. Cancer Med. 2019 Jan;8(1):165-173. doi: 10.1002/cam4.1918. Epub 2018 Dec 21. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Epratuzumab Plus Rituximab | Induction Therapy (Month 1): Epratuzumab 360 mg/m^2 by IV days 1, 8, 15 & 22; Rituximab 375 mg/m^2 by IV day 3, 8, 15 & 22 Extended Induction (Weeks 12, 20, 28 & 36) Epratuzumab 360 mg/m^2 by IV weeks 12, 20, 28 & 36; Rituximab 375 mg/m^2 by IV weeks 12, 20, 28 & 36 |
| 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 | Number of Participants With Overall Response | Overall response is defined as achievement of a complete response (CR) or partial response (PR) as defined by the Revised Response Criteria for Malignant Lymphoma. CR: complete disappearance of all detectable disease PR: >=50% decrease in the sum of the product of diameters of indicator lesions | Posted | Number | participants | 12 months |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival | Progression free survival (PFS) was defined as the time from registration to progression or death of any cause. Progression free and alive patients were censored at the date of last follow-up. The median PFS with 95% CI was estimated using the Kaplan Meier method. | Posted | Median | 95% Confidence Interval | years | Duration of study (up to 10 years) |
|
| ||||||||||||||||||||||||||||||||||
| Post-Hoc | 3-Year Overall Survival | Percentage of participants who were alive at 3 years. The 3 year survival, with 95% confidence interval, was estimated using the Kaplan Meier method. | Posted | Number | 95% Confidence Interval | percentage of participants | 3 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 | Epratuzumab Plus Rituximab | Induction Therapy (Month 1): Epratuzumab 360 mg/m^2 by IV days 1, 8, 15 & 22; Rituximab 375 mg/m^2 by IV day 3, 8, 15 & 22 Extended Induction (Weeks 12, 20, 28 & 36) Epratuzumab 360 mg/m^2 by IV weeks 12, 20, 28 & 36; Rituximab 375 mg/m^2 by IV weeks 12, 20, 28 & 36 | 10 | 59 | 58 | 59 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin decreased | Blood and lymphatic system disorders | MedDRA 6 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 6 | Systematic Assessment |
| |
| Cardiac disorder | Cardiac disorders | MedDRA 6 | Systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | MedDRA 6 | Systematic Assessment |
| |
| Myocardial ischemia | Cardiac disorders | MedDRA 6 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Rectal hemorrhage | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Rectal pain | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Edema limbs | General disorders | MedDRA 6 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 6 | Systematic Assessment |
| |
| Fever | General disorders | MedDRA 6 | Systematic Assessment |
| |
| Localized edema | General disorders | MedDRA 6 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 6 | Systematic Assessment |
| |
| Visceral edema | General disorders | MedDRA 6 | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA 6 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 6 | Systematic Assessment |
| |
| Catheter related infection | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Endocarditis infective | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Peripheral nerve infection | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Cardiac troponin I increased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Creatinine increased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Laboratory test abnormal | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Blood glucose increased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Blood uric acid increased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Serum albumin decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Serum calcium decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Serum glucose decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Serum potassium decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Serum potassium increased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Serum sodium decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Muscle weakness | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Mini mental status examination abnormal | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 6 | Systematic Assessment |
| |
| Bladder hemorrhage | Renal and urinary disorders | MedDRA 6 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 6 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Sweating | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Hot flashes | Vascular disorders | MedDRA 6 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 6 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 6 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 6 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin decreased | Blood and lymphatic system disorders | MedDRA 6 | Systematic Assessment |
| |
| Lymph node pain | Blood and lymphatic system disorders | MedDRA 6 | Systematic Assessment |
| |
| Cardiac disorder | Cardiac disorders | MedDRA 6 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 6 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 6 | Systematic Assessment |
| |
| Dry eye syndrome | Eye disorders | MedDRA 6 | Systematic Assessment |
| |
| Eye disorder | Eye disorders | MedDRA 6 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 6 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Ear, nose and throat examination abnormal | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Gingival pain | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Stomach pain | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 6 | Systematic Assessment |
| |
| Edema limbs | General disorders | MedDRA 6 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 6 | Systematic Assessment |
| |
| Fever | General disorders | MedDRA 6 | Systematic Assessment |
| |
| Flu-like symptoms | General disorders | MedDRA 6 | Systematic Assessment |
| |
| General symptom | General disorders | MedDRA 6 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 6 | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA 6 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 6 | Systematic Assessment |
| |
| Immune system disorder | Immune system disorders | MedDRA 6 | Systematic Assessment |
| |
| Bladder infection | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Catheter related infection | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA 6 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 6 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Creatinine increased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Laboratory test abnormal | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Leukocyte count decreased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Weight loss | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Blood glucose increased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Blood uric acid increased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Serum albumin decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Serum calcium decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Serum calcium increased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Serum glucose decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Serum phosphate decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Serum potassium decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Serum potassium increased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Serum sodium decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Chest wall pain | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Muscle weakness | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Muscle weakness upper limb | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Tumor pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 6 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Extrapyramidal disorder | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Neurological disorder NOS | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 6 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 6 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 6 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 6 | Systematic Assessment |
| |
| Libido decreased | Psychiatric disorders | MedDRA 6 | Systematic Assessment |
| |
| Glomerular filtration rate decreased | Renal and urinary disorders | MedDRA 6 | Systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | MedDRA 6 | Systematic Assessment |
| |
| Urine discoloration | Renal and urinary disorders | MedDRA 6 | Systematic Assessment |
| |
| Urogenital disorder | Renal and urinary disorders | MedDRA 6 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA 6 | Systematic Assessment |
| |
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Hand-and-foot syndrome | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Rash desquamating | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Sweating | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 6 | Systematic Assessment |
| |
| Hot flashes | Vascular disorders | MedDRA 6 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 6 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 6 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Barbara Grant, MD | University of Vermont, Vermont Cancer Center | barbara.grant@vtmednet.org |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
Not provided
Not provided
| ID | Term |
|---|---|
| C448700 | epratuzumab |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|