Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U10CA031946 | U.S. NIH Grant/Contract | View source | |
| CALGB-50602 | |||
| CDR0000561185 | 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 galiximab, 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.
PURPOSE: This phase II trial is studying how well galiximab works in treating patients with relapsed or refractory Hodgkin's lymphoma.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients also undergo FDG-PET/CT imaging at baseline and at time of first restaging (within 7 days prior to week 8 treatment).
After completion of study treatment, patients are followed periodically for 10 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Galaximab | Experimental | Induction: 500 mg/m^2 by IV over 60 minutes days 1, 8, 15 & 22 Extended Induction: 500 mg/m^2 by IV every 4 weeks until disease progression or unacceptable toxicity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| galiximab | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Duration of treatment (up to 10 years) |
| Measure | Description | Time Frame |
|---|---|---|
| 12 Month Overall Survival Rate | Percentage of patients who were alive at 12 months. The 12-month survival rate was estimated using the Kaplan Meier method. | 12 months |
| 6 Month Progression Free Survival Rate |
Not provided
DISEASE CHARACTERISTICS:
Histologically confirmed classical Hodgkin lymphoma (HL):
Recurrent or refractory disease after at least two prior standard chemotherapy regimens
Nodular lymphocyte predominant HL allowed
Measurable disease must be present on either physical examination or imaging studies
Measurable disease is defined as any lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm
Evaluable or non-measurable disease alone is not acceptable including any of the following:
Ineligible for a stem cell transplantation
Patients eligible for CALGB-50502 should not be considered for this study
No known CNS involvement
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
Recovered to ≤ grade 1 from all toxicities related to prior treatments
At least 4 weeks since prior chemotherapy, radiotherapy, or biologic anticancer therapy
Prior autologous and/or allogeneic stem cell transplantation allowed
No prior anti-CD80 antibody
No concurrent steroids, hormones, or other chemotherapeutic agents except for steroids given for adrenal failure and hormones administered for non-disease-related conditions (e.g., insulin for diabetes)
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| Name | Affiliation | Role |
|---|---|---|
| Sonali Smith, MD | University of Chicago | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tunnell Cancer Center at Beebe Medical Center | Lewes | Delaware | 19958 | United States | ||
| CCOP - Christiana Care Health Services |
One patient never received treatment and is excluded from all analyses.
Between June 2008 and January 2009, 30 patients were recruited.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Galaximab | Induction: 500 mg/m^2 by IV over 60 minutes days 1, 8, 15 & 22 Extended Induction: 500 mg/m^2 by IV every 4 weeks until disease progression or unacceptable toxicity |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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Percentage of patients who were progression free at 6 months. The 6-month progression free rate was estimated using the Kaplan Meier method.
Relapse was assessed by investigator according to Revised Response Criteria for Malignant Lymphoma. Progression required a appearance of any new lesion > 1.5 cm, at least 50% increase from nadir in the sum of products of involved nodes, or a 50% increase in the longest diameter of any single node.
| 6 months |
| Newark |
| Delaware |
| 19713 |
| United States |
| Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | United States |
| St. Joseph Medical Center | Bloomington | Illinois | 61701 | United States |
| Graham Hospital | Canton | Illinois | 61520 | United States |
| Memorial Hospital | Carthage | Illinois | 62321 | United States |
| University of Chicago Cancer Research Center | Chicago | Illinois | 60637-1470 | United States |
| Eureka Community Hospital | Eureka | Illinois | 61530 | United States |
| Galesburg Clinic, PC | Galesburg | Illinois | 61401 | United States |
| Galesburg Cottage Hospital | Galesburg | Illinois | 61401 | United States |
| Mason District Hospital | Havana | Illinois | 62644 | United States |
| Hopedale Medical Complex | Hopedale | Illinois | 61747 | United States |
| McDonough District Hospital | Macomb | Illinois | 61455 | United States |
| BroMenn Regional Medical Center | Normal | Illinois | 61761 | United States |
| Community Cancer Center | Normal | Illinois | 61761 | United States |
| Community Hospital of Ottawa | Ottawa | Illinois | 61350 | United States |
| Oncology Hematology Associates of Central Illinois, PC - Ottawa | Ottawa | Illinois | 61350 | United States |
| Cancer Treatment Center at Pekin Hospital | Pekin | Illinois | 61554 | United States |
| Proctor Hospital | Peoria | Illinois | 61614 | United States |
| CCOP - Illinois Oncology Research Association | Peoria | Illinois | 61615 | United States |
| Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria | Illinois | 61615 | United States |
| Methodist Medical Center of Illinois | Peoria | Illinois | 61636 | United States |
| OSF St. Francis Medical Center | Peoria | Illinois | 61637 | United States |
| Illinois Valley Community Hospital | Peru | Illinois | 61354 | United States |
| Perry Memorial Hospital | Princeton | Illinois | 61356 | United States |
| St. Margaret's Hospital | Spring Valley | Illinois | 61362 | United States |
| Elkhart General Hospital | Elkhart | Indiana | 46515 | 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 |
| CancerCare of Maine at Eastern Maine Medical Center | Bangor | Maine | 04401 | United States |
| Union Hospital Cancer Program at Union Hospital | Elkton MD | Maryland | 21921 | United States |
| Lakeland Regional Cancer Care Center - St. Joseph | Saint Joseph | Michigan | 49085 | United States |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St Louis | Missouri | 63110 | United States |
| Cancer Resource Center - Lincoln | Lincoln | Nebraska | 68510 | United States |
| CCOP - Missouri Valley Cancer Consortium | Omaha | Nebraska | 68106 | United States |
| Immanuel Medical Center | Omaha | Nebraska | 68122 | United States |
| Alegant Health Cancer Center at Bergan Mercy Medical Center | Omaha | Nebraska | 68124 | United States |
| Creighton University Medical Center | Omaha | Nebraska | 68131-2197 | United States |
| Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees Township | New Jersey | 08043 | United States |
| New York Weill Cornell Cancer Center at Cornell University | New York | New York | 10021 | United States |
| Mount Sinai Medical Center | New York | New York | 10029 | United States |
| Randolph Hospital | Asheboro | North Carolina | 27203-5400 | United States |
| Presbyterian Cancer Center at Presbyterian Hospital | Charlotte | North Carolina | 28233-3549 | United States |
| Wayne Memorial Hospital, Incorporated | Goldsboro | North Carolina | 27534 | United States |
| Moses Cone Regional Cancer Center at Wesley Long Community Hospital | Greensboro | North Carolina | 27403-1198 | United States |
| Kinston Medical Specialists | Kinston | North Carolina | 28501 | United States |
| Annie Penn Cancer Center | Reidsville | North Carolina | 27320 | 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 |
| Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital | Pittsburgh | Pennsylvania | 15224-1791 | United States |
| Danville Regional Medical Center | Danville | Virginia | 24541 | United States |
| Virginia Commonwealth University Massey Cancer Center | Richmond | Virginia | 23298-0037 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Galaximab | Induction: 500 mg/m^2 by IV over 60 minutes days 1, 8, 15 & 22 Extended Induction: 500 mg/m^2 by IV every 4 weeks until disease progression or unacceptable toxicity |
| 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 |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | 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 | 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 | Duration of treatment (up to 10 years) |
|
|
| |||||||||||||||||||||||||||
| Secondary | 12 Month Overall Survival Rate | Percentage of patients who were alive at 12 months. The 12-month survival rate was estimated using the Kaplan Meier method. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 months |
|
| |||||||||||||||||||||||||||
| Secondary | 6 Month Progression Free Survival Rate | Percentage of patients who were progression free at 6 months. The 6-month progression free rate was estimated using the Kaplan Meier method. Relapse was assessed by investigator according to Revised Response Criteria for Malignant Lymphoma. Progression required a appearance of any new lesion > 1.5 cm, at least 50% increase from nadir in the sum of products of involved nodes, or a 50% increase in the longest diameter of any single node. | Posted | Number | 95% Confidence Interval | percentage of participants | 6 months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Galaximab | Extended Induction: 500 mg/m^2 by IV every 4 weeks until disease progression or unacceptable toxicity | 8 | 29 | 28 | 29 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin decreased | Blood and lymphatic system disorders | MedDRA 6 | Systematic Assessment |
| |
| Cardiac disorder | Cardiac disorders | MedDRA 6 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 6 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 6 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 6 | Systematic Assessment |
| |
| External ear pain | Ear and labyrinth disorders | MedDRA 6 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA 6 | Systematic Assessment |
| |
| Cushingoid | Endocrine disorders | MedDRA 6 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine 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 |
| |
| Colitis | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Diarrhea | 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 |
| |
| Nausea | 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 |
| |
| Facial pain | General disorders | MedDRA 6 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 6 | Systematic Assessment |
| |
| Fever | General disorders | MedDRA 6 | Systematic Assessment |
| |
| General symptom | General disorders | MedDRA 6 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 6 | Systematic Assessment |
| |
| Autoimmune disorder | Immune system disorders | MedDRA 6 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 6 | Systematic Assessment |
| |
| Anal infection | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Catheter related infection | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Joint infection | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Bruising | Injury, poisoning and procedural complications | MedDRA 6 | Systematic Assessment |
| |
| Vascular access complication | Injury, poisoning and procedural complications | MedDRA 6 | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | 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 T increased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Creatinine increased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| INR increased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Leukocyte count decreased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Lipase increased | 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 |
| |
| Acidosis | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Blood glucose increased | 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 magnesium decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Serum magnesium increased | 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 |
| |
| Serum triglycerides increased | 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 |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Treatment related secondary malignancy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 6 | Systematic Assessment |
| |
| Cognitive disturbance | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Neurological disorder NOS | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Syncope | Nervous system 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 |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 6 | Systematic Assessment |
| |
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Bronchopulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Bronchospasm | 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 |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Dry skin | 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 |
| |
| Sweating | Skin and subcutaneous tissue 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 |
|---|---|---|---|---|---|
| Blood disorder | Blood and lymphatic system disorders | MedDRA 6 | Systematic Assessment |
| |
| Hemoglobin decreased | Blood and lymphatic system disorders | MedDRA 6 | Systematic Assessment |
| |
| Lymph node pain | Blood and lymphatic system disorders | MedDRA 6 | Systematic Assessment |
| |
| Cardiac pain | Cardiac disorders | MedDRA 6 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 6 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA 6 | Systematic Assessment |
| |
| Cushingoid | Endocrine disorders | MedDRA 6 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 6 | Systematic Assessment |
| |
| Dry eye syndrome | Eye disorders | MedDRA 6 | Systematic Assessment |
| |
| Flashing vision | 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 |
| |
| Colitis | 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 |
| |
| Ear, nose and throat examination abnormal | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Gastric mucositis | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Nausea | 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 |
| |
| Localized edema | General disorders | MedDRA 6 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 6 | Systematic Assessment |
| |
| Anorectal infection | 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 |
| |
| Infectious colitis | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Joint infection | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Lip infection | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Sinusitis | 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 |
| |
| Bruising | 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 |
| |
| Gamma-glutamyltransferase 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 |
| |
| Serum cholesterol increased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Weight gain | 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 |
| |
| 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 magnesium 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 |
| |
| Serum sodium increased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Serum triglycerides increased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Arthritis | 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 |
| |
| Joint disorder | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Musculoskeletal disorder | 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 |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Acoustic nerve disorder NOS | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Cognitive disturbance | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Speech disorder | 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 |
| |
| Bladder spasm | Renal and urinary disorders | MedDRA 6 | Systematic Assessment |
| |
| Hemoglobin urine positive | Renal and urinary disorders | MedDRA 6 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 6 | Systematic Assessment |
| |
| Urine discoloration | Renal and urinary disorders | MedDRA 6 | Systematic Assessment |
| |
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Bronchopulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Bronchospasm | 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 |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Voice alteration | Respiratory, thoracic and mediastinal 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 |
| |
| Scalp pain | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Sweating | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 6 | Systematic Assessment |
|
Must obtain prior Sponsor approval.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sonali Smith, M.D. | University of Chicago | smsmith@medicine.bsd.uchicago.edu |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D006689 | Hodgkin Disease |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C437823 | galiximab |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Denominators | Categories |
|---|
|
|