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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA015083 | U.S. NIH Grant/Contract | View source | |
| MC048G | Other Identifier | Mayo Clinic Cancer Cancer | |
| 1042-05 | Other Identifier | Mayo Clinic IRB |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer.
PURPOSE: This phase II trial is studying the side effects and how well everolimus works in treating patients with lymphoma that has relapsed or not responded to previous treatment.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to histology (aggressive lymphoma [closed to accrual as of 2/7/08 except for diffuse large B cell lymphoma, grade III follicular lymphoma, or transformed lymphoma] vs indolent lymphoma [closed to accrual as of 8/18/08] vs uncommon lymphoma [closed to accrual as of 9/2/08]).
Patient receive oral everolimus daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Patients undergo blood and tissue collection at baseline and periodically during study treatment for translational research studies. Blood and tissue samples are analyzed for biomarkers to study the effect of everolimus on lymphoma.
After completion of study treatment, patients are followed periodically for up to 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Relapsed aggressive non-Hodgkin lymphoma | Experimental | Study 1. Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time. |
|
| Relapsed indolent non-Hodgkin lymphoma | Experimental | Study 2. Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time. |
|
| Uncommon lymphomas | Experimental | Study 3. Includes Hodgkin's lymphomas. Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Everolimus | Drug | Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Response, Defined by Disease: Chronic Lymphocytic Leukemia(CLL): Clinical Complete or Complete or Nodular Partial or Partial Remission, Waldenstrom: Complete or Partial Response, All Others: Complete or Complete Unconfirmed or Partial Response. | CLL (subset of patients in the Relapsed Indolent Non-Hodgkin Lymphoma group): 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, >100000/μL platelets, >11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions. Waldenstrom (subset of patients in the Uncommon Lymphomas group): >50% reduction in serum immunoglobulin M(IgM) levels (by serum protein electrophoresis (SPEP)) during any point while in this study, and no appearance of new lesions. All others: at least a 50% decrease in the sum of the products of the greatest diameters (SPD) of the six largest dominant nodes or nodal masses and no increase in the size of other nodes, liver, or spleen and splenic and hepatic nodules must regress by at least 50% in the SPD and no new sites of disease. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | The overall survival or survival time is defined as the time from registration to death due to any cause. The distribution of overall survival was estimated using the method of Kaplan-Meier. | 5 years |
| Progression-free Survival |
Not provided
DISEASE CHARACTERISTICS:
Biopsy-proven* relapsed or refractory lymphoma, including the following:
Aggressive lymphoma (closed to accrual as of 2/7/08 except for diffuse large B cell lymphoma, grade III follicular lymphoma, or transformed lymphoma)
Indolent lymphoma (closed to accrual as of 8/18/08)
Uncommon lymphoma (closed to accrual as of 9/2/08)
NOTE: *Biopsies performed < 6 months prior to study entry are allowed; biopsy-proven CNS lymphoma (at any time) does not require a re-biopsy in order to be eligible for this study
Previously treated disease
Measurable disease** by CT scan or MRI, defined by 1 of the following:
At least 1 unidimensionally measurable lesion > 2 cm in diameter
More than 5,000/mm³ tumor cells in the blood
NOTE: **For patients with lymphoplasmacytic lymphoma without measurable lymphadenopathy, measurable disease may be defined by bone marrow lymphoplasmacytosis with > 10% lymphoplasmacytic cells or aggregates, sheets, lymphocytes, plasma cells, or lymphoplasmacytic cells on bone marrow biopsy AND quantitative Immunoglobulin M(IgM) monoclonal protein > 1,000 mg/dL
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
At least 3 weeks since prior myelosuppressive chemotherapy or biologic therapy (unless the patient has recovered from the nadir of the previous treatment)
More than 3 weeks since prior radiotherapy (unless the acute side effects associated with therapy are resolved)
Concurrent stable (i.e., not increased within the past month) chronic doses of corticosteroids, with a maximum dose of 20 mg of prednisone per day, is allowed if prescribed for disorders other than lymphoma (e.g., rheumatoid arthritis, polymyalgia rheumatica, adrenal insufficiency, or asthma)
No other concurrent investigational ancillary therapy
No other concurrent chemotherapy, immunotherapy, or radiotherapy
No concurrent participation in any other clinical trial involving a pharmacologic agent (e.g., drugs, biologics, immunotherapy, or gene therapy) for symptom control or therapeutic intent
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| Name | Affiliation | Role |
|---|---|---|
| Thomas E. Witzig, MD | Mayo Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Scottsdale | Scottsdale | Arizona | 85259-5499 | United States | ||
| Mayo Clinic - Jacksonville |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20142598 | Result | Ghobrial IM, Gertz M, Laplant B, Camoriano J, Hayman S, Lacy M, Chuma S, Harris B, Leduc R, Rourke M, Ansell SM, Deangelo D, Dispenzieri A, Bergsagel L, Reeder C, Anderson KC, Richardson PG, Treon SP, Witzig TE. Phase II trial of the oral mammalian target of rapamycin inhibitor everolimus in relapsed or refractory Waldenstrom macroglobulinemia. J Clin Oncol. 2010 Mar 10;28(8):1408-14. doi: 10.1200/JCO.2009.24.0994. Epub 2010 Feb 8. | |
| 20229590 | Result |
Not provided
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277 patients were accrued from 4 medical clinics in the United States between August 2005 and May 2010. One patient withdrew before starting treatment and thus excluded from the results.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Relapsed Aggressive Non-Hodgkin Lymphoma | Study 1. Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time. Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time. |
| FG001 | Relapsed Indolent Non-Hodgkin Lymphoma | Study 2. Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time. Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time. |
| FG002 | Uncommon Lymphomas | Study 3. Includes Hodgkin's lymphomas. Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time. Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Relapsed Aggressive Non-Hodgkin Lymphoma | Study 1. Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time. Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Tumor Response, Defined by Disease: Chronic Lymphocytic Leukemia(CLL): Clinical Complete or Complete or Nodular Partial or Partial Remission, Waldenstrom: Complete or Partial Response, All Others: Complete or Complete Unconfirmed or Partial Response. | CLL (subset of patients in the Relapsed Indolent Non-Hodgkin Lymphoma group): 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, >100000/μL platelets, >11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions. Waldenstrom (subset of patients in the Uncommon Lymphomas group): >50% reduction in serum immunoglobulin M(IgM) levels (by serum protein electrophoresis (SPEP)) during any point while in this study, and no appearance of new lesions. All others: at least a 50% decrease in the sum of the products of the greatest diameters (SPD) of the six largest dominant nodes or nodal masses and no increase in the size of other nodes, liver, or spleen and splenic and hepatic nodules must regress by at least 50% in the SPD and no new sites of disease. | 276 out of 277 were analyzed for response. One patient was excluded because of patient refusal before starting treatment. | Posted | Number | 95% Confidence Interval | percentage of patients in group | 5 years |
Not provided
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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 | Relapsed Aggressive Non-Hodgkin Lymphoma | Study 1. Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time. Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 10 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 10 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas E. Witzig M.D. | Mayo Clinic | (507) 284-0527 | witzig.thomas@mayo.edu |
Not provided
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D008232 | Lymphoproliferative Disorders |
| D002051 | Burkitt Lymphoma |
| D006689 | Hodgkin Disease |
| D017728 | Lymphoma, Large-Cell, Anaplastic |
| D007119 | Immunoblastic Lymphadenopathy |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D008228 | Lymphoma, Non-Hodgkin |
| D054218 | Precursor T-Cell Lymphoblastic Leukemia-Lymphoma |
| D008224 | Lymphoma, Follicular |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D009182 | Mycosis Fungoides |
| D012751 | Sezary Syndrome |
| D054391 | Lymphoma, Extranodal NK-T-Cell |
| D008258 | Waldenstrom Macroglobulinemia |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D054198 |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068338 | Everolimus |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Progression-free survival is defined as the time from registration to the time of progression or death due to any cause. Progression-free survival was estimated using the method of Kaplan-Meier.
Progression is defined as the following:
CLL (subset of patients in the Relapsed Indolent Non-Hodgkin Lymphoma group): >=50% increase in nodes from nadir or >=50% increase in liver/spleen size from nadir.
Waldenstrom (subset of patients in the Uncommon Lymphomas group): >50% lymph node increase in SPD of > 1 node or new nodes, or >50% liver/spleen size increase, or > 25% IgM (by SPEP) increase, or lymphocyte morphology transformation to a more aggressive histology.
All Others: New lesions or >=50% lymph nodes.
| 5 years |
| Time to Progression | The time to progression is defined as the time from registration to the time of progression. The distribution of time to progression was estimated using the method of Kaplan-Meier. | 5 years |
| Jacksonville |
| Florida |
| 32224 |
| United States |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | United States |
| Johnston PB, Inwards DJ, Colgan JP, Laplant BR, Kabat BF, Habermann TM, Micallef IN, Porrata LF, Ansell SM, Reeder CB, Roy V, Witzig TE. A Phase II trial of the oral mTOR inhibitor everolimus in relapsed Hodgkin lymphoma. Am J Hematol. 2010 May;85(5):320-4. doi: 10.1002/ajh.21664. |
| 21135857 | Result | Witzig TE, Reeder CB, LaPlant BR, Gupta M, Johnston PB, Micallef IN, Porrata LF, Ansell SM, Colgan JP, Jacobsen ED, Ghobrial IM, Habermann TM. A phase II trial of the oral mTOR inhibitor everolimus in relapsed aggressive lymphoma. Leukemia. 2011 Feb;25(2):341-7. doi: 10.1038/leu.2010.226. Epub 2010 Dec 7. |
| 20166206 | Result | Zent CS, LaPlant BR, Johnston PB, Call TG, Habermann TM, Micallef IN, Witzig TE. The treatment of recurrent/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL) with everolimus results in clinical responses and mobilization of CLL cells into the circulation. Cancer. 2010 May 1;116(9):2201-7. doi: 10.1002/cncr.25005. |
| 25921059 | Derived | Witzig TE, Reeder C, Han JJ, LaPlant B, Stenson M, Tun HW, Macon W, Ansell SM, Habermann TM, Inwards DJ, Micallef IN, Johnston PB, Porrata LF, Colgan JP, Markovic S, Nowakowski GS, Gupta M. The mTORC1 inhibitor everolimus has antitumor activity in vitro and produces tumor responses in patients with relapsed T-cell lymphoma. Blood. 2015 Jul 16;126(3):328-35. doi: 10.1182/blood-2015-02-629543. Epub 2015 Apr 28. |
| Alternate Treatment |
|
| Other Medical Problems |
|
| Death |
|
| New Primary or Other Reasons |
|
| Still on treatment |
|
| BG001 |
| Relapsed Indolent Non-Hodgkin Lymphoma |
Study 2. Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time. Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time. |
| BG002 | Uncommon Lymphomas | Study 3. Includes Hodgkin's lymphomas. Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time. Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Hodgkin versus Non-Hodgkin Lymphoma | Number | participants |
|
|
|
|
| Secondary | Overall Survival | The overall survival or survival time is defined as the time from registration to death due to any cause. The distribution of overall survival was estimated using the method of Kaplan-Meier. | 276 out of 277 were analyzed for response. One patient was excluded because of patient refusal before starting treatment. | Posted | Median | 95% Confidence Interval | years | 5 years |
|
|
|
| Secondary | Progression-free Survival | Progression-free survival is defined as the time from registration to the time of progression or death due to any cause. Progression-free survival was estimated using the method of Kaplan-Meier. Progression is defined as the following: CLL (subset of patients in the Relapsed Indolent Non-Hodgkin Lymphoma group): >=50% increase in nodes from nadir or >=50% increase in liver/spleen size from nadir. Waldenstrom (subset of patients in the Uncommon Lymphomas group): >50% lymph node increase in SPD of > 1 node or new nodes, or >50% liver/spleen size increase, or > 25% IgM (by SPEP) increase, or lymphocyte morphology transformation to a more aggressive histology. All Others: New lesions or >=50% lymph nodes. | 276 out of 277 were analyzed for response. One patient was excluded because of patient refusal before starting treatment. | Posted | Median | 95% Confidence Interval | years | 5 years |
|
|
|
| Secondary | Time to Progression | The time to progression is defined as the time from registration to the time of progression. The distribution of time to progression was estimated using the method of Kaplan-Meier. | 276 out of 277 were analyzed for response. One patient was excluded because of patient refusal before starting treatment. | Posted | Median | 95% Confidence Interval | years | 5 years |
|
|
|
| 38 |
| 114 |
| 113 |
| 114 |
| EG001 | Relapsed Indolent Non-Hodgkin Lymphoma | Study 2. Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time. Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time. | 11 | 55 | 55 | 55 |
| EG002 | Uncommon Lymphomas | Study 3. Includes Hodgkin's lymphomas. Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time. Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time. | 25 | 107 | 107 | 107 |
| Hemoglobin decreased | Blood and lymphatic system disorders | MedDRA 10 | Systematic Assessment |
|
| Atrial tachycardia | Cardiac disorders | MedDRA 10 | Systematic Assessment |
|
| Cardiac disorder | Cardiac disorders | MedDRA 10 | Systematic Assessment |
|
| Cardiopulmonary arrest | Cardiac disorders | MedDRA 10 | Systematic Assessment |
|
| Myocardial ischemia | Cardiac disorders | MedDRA 10 | Systematic Assessment |
|
| Restrictive cardiomyopathy | Cardiac disorders | MedDRA 10 | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA 10 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
|
| Colonic perforation | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
|
| Intra-abdominal hemorrhage | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
|
| Mucositis oral | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
|
| Upper gastrointestinal hemorrhage | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
|
| Disease progression | General disorders | MedDRA 10 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 10 | Systematic Assessment |
|
| Fever | General disorders | MedDRA 10 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 10 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 10 | Systematic Assessment |
|
| Biliary tract infection | Infections and infestations | MedDRA 10 | Systematic Assessment |
|
| Colitis, infectious (e.g., Clostridium difficile) | Infections and infestations | MedDRA 10 | Systematic Assessment |
|
| Gingival infection | Infections and infestations | MedDRA 10 | Systematic Assessment |
|
| Opportunistic infection | Infections and infestations | MedDRA 10 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 10 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 10 | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA 10 | Systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | MedDRA 10 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 10 | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | MedDRA 10 | Systematic Assessment |
|
| Creatinine increased | Investigations | MedDRA 10 | Systematic Assessment |
|
| Leukocyte count decreased | Investigations | MedDRA 10 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 10 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 10 | Systematic Assessment |
|
| Blood glucose increased | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
|
| Serum calcium decreased | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
|
| Serum potassium decreased | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
|
| Serum sodium decreased | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 10 | Systematic Assessment |
|
| Ischemia cerebrovascular | Nervous system disorders | MedDRA 10 | Systematic Assessment |
|
| Speech disorder | Nervous system disorders | MedDRA 10 | Systematic Assessment |
|
| Confusion | Psychiatric disorders | MedDRA 10 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 10 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 10 | Systematic Assessment |
|
| Urethral obstruction | Renal and urinary disorders | MedDRA 10 | Systematic Assessment |
|
| Adult respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 10 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 10 | Systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA 10 | Systematic Assessment |
|
| Hemoglobin decreased | Blood and lymphatic system disorders | MedDRA 10 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 10 | Systematic Assessment |
|
| Cardiac disorder | Cardiac disorders | MedDRA 10 | Systematic Assessment |
|
| Cardiac pain | Cardiac disorders | MedDRA 10 | Systematic Assessment |
|
| Left ventricular failure | Cardiac disorders | MedDRA 10 | Systematic Assessment |
|
| Myocardial ischemia | Cardiac disorders | MedDRA 10 | Systematic Assessment |
|
| Myocarditis | Cardiac disorders | MedDRA 10 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 10 | Systematic Assessment |
|
| Restrictive cardiomyopathy | Cardiac disorders | MedDRA 10 | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA 10 | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA 10 | Systematic Assessment |
|
| Hearing impaired | Ear and labyrinth disorders | MedDRA 10 | Systematic Assessment |
|
| Adrenal insufficiency | Endocrine disorders | MedDRA 10 | Systematic Assessment |
|
| Eye disorder | Eye disorders | MedDRA 10 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
|
| Ear, nose and throat examination abnormal | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
|
| Hemorrhoids | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
|
| Mucositis oral | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
|
| Proctoscopy abnormal | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
|
| Rectal hemorrhage | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
|
| Rectal pain | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 10 | Systematic Assessment |
|
| Disease progression | General disorders | MedDRA 10 | Systematic Assessment |
|
| Edema limbs | General disorders | MedDRA 10 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 10 | Systematic Assessment |
|
| Fever | General disorders | MedDRA 10 | Systematic Assessment |
|
| General symptom | General disorders | MedDRA 10 | Systematic Assessment |
|
| Ill-defined disorder | General disorders | MedDRA 10 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 10 | Systematic Assessment |
|
| Visceral edema | General disorders | MedDRA 10 | Systematic Assessment |
|
| Gallbladder obstruction | Hepatobiliary disorders | MedDRA 10 | Systematic Assessment |
|
| Abdominal infection | Infections and infestations | MedDRA 10 | Systematic Assessment |
|
| Anal infection | Infections and infestations | MedDRA 10 | Systematic Assessment |
|
| Bladder infection | Infections and infestations | MedDRA 10 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 10 | Systematic Assessment |
|
| Catheter related infection | Infections and infestations | MedDRA 10 | Systematic Assessment |
|
| Cecal infection | Infections and infestations | MedDRA 10 | Systematic Assessment |
|
| Colitis, infectious (e.g., Clostridium difficile) | Infections and infestations | MedDRA 10 | Systematic Assessment |
|
| Gastric infection | Infections and infestations | MedDRA 10 | Systematic Assessment |
|
| Gingival infection | Infections and infestations | MedDRA 10 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 10 | Systematic Assessment |
|
| Lip infection | Infections and infestations | MedDRA 10 | Systematic Assessment |
|
| Mucosal infection | Infections and infestations | MedDRA 10 | Systematic Assessment |
|
| Otitis externa | Infections and infestations | MedDRA 10 | Systematic Assessment |
|
| Penile infection | Infections and infestations | MedDRA 10 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 10 | Systematic Assessment |
|
| Pleural infection | Infections and infestations | MedDRA 10 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 10 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 10 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 10 | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA 10 | Systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA 10 | Systematic Assessment |
|
| Upper aerodigestive tract infection | Infections and infestations | MedDRA 10 | Systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | MedDRA 10 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 10 | Systematic Assessment |
|
| Viral hepatitis | Infections and infestations | MedDRA 10 | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA 10 | Systematic Assessment |
|
| Radiation recall reaction (dermatologic) | Injury, poisoning and procedural complications | MedDRA 10 | Systematic Assessment |
|
| Vascular access complication | Injury, poisoning and procedural complications | MedDRA 10 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 10 | Systematic Assessment |
|
| Alkaline phosphatase increased | Investigations | MedDRA 10 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 10 | Systematic Assessment |
|
| Cardiac troponin I increased | Investigations | MedDRA 10 | Systematic Assessment |
|
| Creatinine increased | Investigations | MedDRA 10 | Systematic Assessment |
|
| Leukocyte count decreased | Investigations | MedDRA 10 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA 10 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 10 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 10 | Systematic Assessment |
|
| Serum cholesterol increased | Investigations | MedDRA 10 | Systematic Assessment |
|
| Weight loss | Investigations | MedDRA 10 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
|
| Blood glucose increased | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
|
| Blood uric acid increased | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
|
| Glucose intolerance | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
|
| Serum albumin decreased | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
|
| Serum calcium decreased | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
|
| Serum glucose decreased | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
|
| Serum potassium decreased | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
|
| Serum potassium increased | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
|
| Serum sodium decreased | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
|
| Serum triglycerides increased | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
|
| Tumor lysis syndrome | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 10 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 10 | Systematic Assessment |
|
| Chest wall pain | Musculoskeletal and connective tissue disorders | MedDRA 10 | Systematic Assessment |
|
| Muscle weakness | Musculoskeletal and connective tissue disorders | MedDRA 10 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 10 | Systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 10 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 10 | Systematic Assessment |
|
| Treatment related secondary malignancy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10 | Systematic Assessment |
|
| Accessory nerve disorder | Nervous system disorders | MedDRA 10 | Systematic Assessment |
|
| Ataxia | Nervous system disorders | MedDRA 10 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 10 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 10 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 10 | Systematic Assessment |
|
| Ischemia cerebrovascular | Nervous system disorders | MedDRA 10 | Systematic Assessment |
|
| Mini mental status examination abnormal | Nervous system disorders | MedDRA 10 | Systematic Assessment |
|
| Neurological disorder NOS | Nervous system disorders | MedDRA 10 | Systematic Assessment |
|
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 10 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 10 | Systematic Assessment |
|
| Radiculitis brachial | Nervous system disorders | MedDRA 10 | Systematic Assessment |
|
| Speech disorder | Nervous system disorders | MedDRA 10 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 10 | Systematic Assessment |
|
| Trigeminal nerve disorder | Nervous system disorders | MedDRA 10 | Systematic Assessment |
|
| Confusion | Psychiatric disorders | MedDRA 10 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 10 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 10 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 10 | Systematic Assessment |
|
| Ureteric stenosis | Renal and urinary disorders | MedDRA 10 | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA 10 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 10 | Systematic Assessment |
|
| Adult respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Systematic Assessment |
|
| Laryngeal mucositis | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Systematic Assessment |
|
| Laryngoscopy abnormal | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Systematic Assessment |
|
| Pharyngeal examination abnormal | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Systematic Assessment |
|
| Pharyngeal stenosis | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Systematic Assessment |
|
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Systematic Assessment |
|
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Systematic Assessment |
|
| Pulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Systematic Assessment |
|
| Voice alteration | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 10 | Systematic Assessment |
|
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 10 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 10 | Systematic Assessment |
|
| Rash acneiform | Skin and subcutaneous tissue disorders | MedDRA 10 | Systematic Assessment |
|
| Rash desquamating | Skin and subcutaneous tissue disorders | MedDRA 10 | Systematic Assessment |
|
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA 10 | Systematic Assessment |
|
| Sweating | Skin and subcutaneous tissue disorders | MedDRA 10 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 10 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 10 | Systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA 10 | Systematic Assessment |
|
| Vascular disorder | Vascular disorders | MedDRA 10 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D020522 | Lymphoma, Mantle-Cell |
| 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 |
| D016399 | Lymphoma, T-Cell |
| D000072281 | Lymphadenopathy |
| D007945 | Leukemia, Lymphoid |
| D015448 | Leukemia, B-Cell |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016410 | Lymphoma, T-Cell, Cutaneous |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |