| ID | Type | Description | Link |
|---|---|---|---|
| 93-C-0133 |
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5-Drug Combination Chemotherapy with Hematologic Toxicity Attenuation. Etoposide phosphate, prednisone, vincristine sulfate (Oncovin), cyclophosphamide, and doxorubicin hydrochloride (hydroxydaunorubicin)(EPOCH): Etoposide, VP-16, NSC-141540; Prednisone, PRED, NSC-10023; Vincristine, VCR, NSC-67574; Cyclophosphamide, CTX, NSC-26271; Doxorubicin, DOX, NSC-123127; with Granulocyte Colony-Stimulating Factor (Amgen), Granulocyte colony-stimulating factor (G-CSF), NSC-614629.
Background:
The treatment of the intermediate and aggressive non-Hodgkin's lymphomas in adults and children commonly induces complete responses in a sizable fraction of the treated population, and about 2/3 of the complete responders appear to have prolonged disease-free survival.
The present study assesses the activity and tolerability in previously untreated patients of a regimen of etoposide phosphate, prednisone, vincristine sulfate (Oncovin), cyclophosphamide, and doxorubicin hydrochloride (hydroxydaunorubicin)(EPOCH) infusional chemotherapy given intensively with granulocyte colony-stimulating factor (G-CSF) support.
Objectives:
Primary:
Assess complete response (CR) and progression-free survival (PFS) of dose-adjusted EPOCH-Rituximab (DA-EPOCH-R) with G-CSF in aggressive B-cell lymphomas.
Eligibility:
Non-Hodgkin's lymphomas in the following categories: mediastinal gray zone lymphoma (MGZL) and primary mediastinal B cell lymphoma (PMBL).
Patients greater than or equal to 12 years old.
Any Stage for PMBL and MGZL.
No prior systemic chemotherapy.
Human immunodeficiency virus (HIV) negative.
Design:
This study will estimate the complete response rate of a group of previously untreated patients and the extent to which EPOCH infusional drug delivery accompanied by a hematopoietic growth factor can increase the dose intensity of treatment.
Patients receive prednisone orally for 5 days, a 96-hour infusion of vincristine, doxorubicin, and etoposide, and a bolus of cyclophosphamide on day 5.
Cycles are repeated every 21 days for a total of 6-8 cycles.
Patients with cluster of differentiation 20 (CD20) expressing tumors (i.e., mature B-cell lymphomas) will also receive rituximab, the humanized monoclonal antibody against the CD20 receptor on day 1 of each cycle.
A total of 348 patients will be enrolled on this protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| With EPOCH-R (Etoposide, Doxorubicin, Prednisone, Cyclophosphamide and Rituximab) | Experimental | Subgroup 1 (SG1) - All participants who received combination Rituximab (EPOCH-R). Rituximab 375 mg/m^2 intravenous (IV) on day 1, every 21 days, prednisone 100mg by mouth (PO) twice a day (bid) on days 1 through 5 every 21 days, and cyclophosphamide 750mg/m^2 on day 5 every 21 days. Doxorubicin 10mg/m^2/day, vincristine 0.4mg/m^2/day, and etoposide 50mg/m^2/day were delivered as continuous intravenous (CIV) infusions over 96 hours starting on day 1 every 21 days. Dose levels were adjusted on doxorubicin, etoposide, and cyclophosphamide each cycle based on neutrophil nadir. |
|
| EPOCH Alone (Etoposide, Doxorubicin, Prednisone, and Cyclophosphamide) | Experimental | Subgroup 2 (SG2) - EPOCH alone: All participants who received Prednisone 100mg by mouth (PO) twice a day (bid) on days 1 through 5 every 21 days, and cyclophosphamide 750mg/m^2 on day 5 every 21 days. Doxorubicin 10mg/m^2/day, vincristine 0.4mg/m^2/day, and etoposide 50mg/m^2/day were delivered as continuous intravenous (CIV) infusions over 96 hours starting on day 1 every 21 days. Dose levels were adjusted on doxorubicin, etoposide, and cyclophosphamide each cycle based on neutrophil nadir. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etoposide | Drug | Etoposide 50mg/m^2/day were delivered as continuous intravenous (CIV) infusions over 96 hours starting on day 1 every 21 days. Combination chemotherapy given with Rituximab, Etoposide, VP-16; Prednisone, Cyclophosphamide, Vincristine, and Doxorubicin (EPOCH-R) intravenous (IV) every 3 weeks for 6 cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response (Complete Response + Partial Response) | Overall response defined as a Complete Response + Partial Response was measured by the Response Criteria. Complete Response is disappearance of all signs and symptoms of lymphoma for a period of at least one month. Partial Response is 50% or greater decrease in the sum of the products of the longest perpendicular diameters of all measured lesions lasting for a period of at least one month. | Time frame was from beginning of therapy until the end of therapy, an average of 6 months |
| Progression Free Survival (PFS) | The Dixon-Simon method will be used to determine whether large B-cell lymphomas expressing BCL-2 (+) participants may experience an improved progression free survival with Etoposide, VP-16, and Doxorubicin with Prednisone, Cyclophosphamide, and Rituximab (EPOCH-R) compared to EPOCH alone, and to obtain a concurrent, precisely determined measure of progression free survival. PFS is the time from start of treatment to documented evidence of disease progression. Progression is an increase of 25% or more in the sum of the products of the longest perpendicular diameters of all measured lesions, or the appearance of any new lesions measured by the Response Criteria. | Progression free survival was calculated from study entry until progression or death from any cause. Median follow up of evaluable participants was 5 years (range 2-7 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With Serious and/or Non-serious Adverse Events Leading to Discontinuation of Therapy | Here is the proportion of participants with adverse events leading to discontinuation of therapy. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the participant and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
Non-Hodgkin's lymphomas in the following categories: mediastinal gray zone lymphoma and primary mediastinal B cell lymphoma.
Diagnosis confirmed by staff of the Hematopathology Section, Laboratory of Pathology, National Cancer Institute (NCI). Tissue blocks from patients treated in extramural sites must be forwarded to the NCI for analysis of B-cell leukemia/lymphoma 2 (bcl-2) by immunohistochemistry (IHC) and other markers within 1 month of study entry.
Patients greater than or equal to 12 years old.
Stage and Prognosis of Patients: Any stage for mediastinal gray zone lymphoma (MGZL) and primary mediastinal B-cell lymphoma (PMBL).
No prior systemic chemotherapy. Patients may be entered if they have had prior limited-field radiotherapy, a short course of glucocorticoids and/or cyclophosphamide for an urgent problem at diagnosis (e.g. epidural cord compression, superior vena cava syndrome).
Human immunodeficiency virus (HIV) negative.
Not pregnant or nursing.
Adequate major organ function [in adults: serum creatinine less than or equal to 1.5 mg/dl or creatinine clearance greater than 60 ml/min; and in children serum creatinine (CR) less than or equal to age-adjusted normal (age 12 to 15 maximum serum creatinine 1.2 mg/dl and age greater than 15 maximum serum creatinine 1.5 mg/dl); bilirubin less than 1.5 mg/dl; absolute neutrophil count (ANC) greater than 1,000 and platelets greater than 100,000) unless impairment is due to organ involvement by lymphoma or immune-mediated mechanism caused by lymphoma.
No active symptomatic ischemic heart disease, myocardial infarction or congestive heart failure within the past year. If multi-gated acquisition (MUGA) is obtained, the left ventricular ejection fraction (LVEF) should exceed 40%.
No other serious concomitant medical illnesses or uncontrolled active infection that would jeopardize the patient's ability to receive the regimen with reasonable safety.
No history of unrelated (non-lymphomatous) neoplasms within past 5 years other than non-melanoma skin cancer or in-situ cancer.
Ability to give informed consent.](streamdown:incomplete-link)
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| Name | Affiliation | Role |
|---|---|---|
| Mark J Roschewski, M.D. | National Cancer Institute (NCI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Holy Cross Hospital, Fort Lauderdale | Fort Lauderdale | Florida | 33308 | United States | ||
| University of Maryland, Baltimore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2580468 | Background | Klimo P, Connors JM. MACOP-B chemotherapy for the treatment of diffuse large-cell lymphoma. Ann Intern Med. 1985 May;102(5):596-602. doi: 10.7326/0003-4819-102-5-596. | |
| 1682280 | Background | Lai GM, Chen YN, Mickley LA, Fojo AT, Bates SE. P-glycoprotein expression and schedule dependence of adriamycin cytotoxicity in human colon carcinoma cell lines. Int J Cancer. 1991 Nov 11;49(5):696-703. doi: 10.1002/ijc.2910490512. |
| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
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All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request.
Clinical data available during the study and indefinitely.
Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI).
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| ID | Title | Description |
|---|---|---|
| FG000 | With EPOCH-R (Etoposide, Doxorubicin, Prednisone, Cyclophosphamide and Rituximab) | Subgroup 1 (SG1) - All participants who received combination Rituximab (EPOCH-R). Rituximab 375 mg/m^2 intravenous (IV) on day 1, every 21 days, prednisone 100mg by mouth (PO) twice a day (bid) on days 1 through 5 every 21 days, and cyclophosphamide 750mg/m^2 on day 5 every 21 days. Doxorubicin 10mg/m^2/day, vincristine 0.4mg/m^2/day, and etoposide 50mg/m^2/day were delivered as continuous intravenous (CIV) infusions over 96 hours starting on day 1 every 21 days. Dose levels were adjusted on doxorubicin, etoposide, and cyclophosphamide each cycle based on neutrophil nadir. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 20, 2021 |
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| Rituximab | Biological | Rituximab given on Day 1 of combination chemotherapy (EPOCH-R) every 3 weeks for 6 cycles. Combination chemotherapy given with Rituximab, Etoposide, VP-16; Prednisone, Cyclophosphamide, Vincristine, and Doxorubicin (EPOCH-R) intravenous (IV) every 3 weeks for 6 cycles. |
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| Prednisone | Drug | Prednisone 100mg by mouth (PO) twice a day (bid) on days 1 through 5 every 21 days. Combination chemotherapy given with Rituximab, Etoposide, VP-16; Prednisone, Cyclophosphamide, Vincristine, and Doxorubicin (EPOCH-R) intravenous (IV) every 3 weeks for 6 cycles. |
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| Cyclophosphamide | Drug | Cyclophosphamide 750mg/m^2 on day 5 every 21 days. Combination chemotherapy given with Rituximab, Etoposide, VP-16; Prednisone, Cyclophosphamide, Vincristine, and Doxorubicin (EPOCH-R) intravenous (IV) every 3 weeks for 6 cycles. |
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| Vincristine | Drug | Vincristine 0.4mg/m^2/day. Combination chemotherapy given with Rituximab, Etoposide, VP-16; Prednisone, Cyclophosphamide, Vincristine, and Doxorubicin (EPOCH-R) intravenous (IV) every 3 weeks for 6 cycles. |
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| Doxorubicin | Drug | Doxorubicin 10mg/m^2/day. Combination chemotherapy given with Rituximab, Etoposide, VP-16; Prednisone, Cyclophosphamide, Vincristine, and Doxorubicin (EPOCH-R) intravenous (IV) every 3 weeks for 6 cycles. |
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| MRI | Diagnostic Test | Baseline and/or on completion of therapy. |
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| CT | Diagnostic Test | Baseline and/or on completion of therapy. |
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| Biopsy | Procedure | Baseline and/or on completion of therapy. |
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| PET scan | Diagnostic Test | As clinically indicated. |
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| Laparotomy | Procedure | As clinically indicated. |
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| Ondansetron | Other | Nausea and/or vomiting. |
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| Prochlorperazine | Other | Nausea and/or vomiting. |
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| Omeprazole | Other | Gastroesophageal reflux disease (GERD). |
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| Docusate Sodium + Sennosides | Other | Constipation. |
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| Lactulose | Other | Constipation |
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| Initiation of study drug until 30 days after treatment, an average of 6 months |
| Time frame is from study entry until 30 days after completing study therapy, approximately 5 years. |
| Baltimore |
| Maryland |
| 21201-1595 |
| United States |
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| St. Luke's Roosevelt Hospital | New York | New York | 10025 | United States |
| 46388 | Background | DeVita VT Jr, Canellos GP, Chabner B, Schein P, Hubbard SP, Young RC. Advanced diffuse histiocytic lymphoma, a potentially curable disease. Lancet. 1975 Feb 1;1(7901):248-50. doi: 10.1016/s0140-6736(75)91142-3. |
| 35882475 | Derived | Lai C, Cole DE, Steinberg SM, Lucas N, Dombi E, Melani C, Roschewski M, Balis F, Widemann BC, Wilson WH. Doxorubicin pharmacokinetics and toxicity in patients with aggressive lymphoma and hepatic impairment. Blood Adv. 2023 Feb 28;7(4):529-532. doi: 10.1182/bloodadvances.2022007431. |
| 34432874 | Derived | Miljkovic MD, Melani C, Pittaluga S, Lakhotia R, Lucas N, Jacob A, Yusko E, Jaffe ES, Wilson WH, Roschewski M. Next-generation sequencing-based monitoring of circulating tumor DNA reveals clonotypic heterogeneity in untreated PTCL. Blood Adv. 2021 Oct 26;5(20):4198-4210. doi: 10.1182/bloodadvances.2020003679. |
| 30125215 | Derived | Kurtz DM, Scherer F, Jin MC, Soo J, Craig AFM, Esfahani MS, Chabon JJ, Stehr H, Liu CL, Tibshirani R, Maeda LS, Gupta NK, Khodadoust MS, Advani RH, Levy R, Newman AM, Duhrsen U, Huttmann A, Meignan M, Casasnovas RO, Westin JR, Roschewski M, Wilson WH, Gaidano G, Rossi D, Diehn M, Alizadeh AA. Circulating Tumor DNA Measurements As Early Outcome Predictors in Diffuse Large B-Cell Lymphoma. J Clin Oncol. 2018 Oct 1;36(28):2845-2853. doi: 10.1200/JCO.2018.78.5246. Epub 2018 Aug 20. |
| 29748435 | Derived | Melani C, Advani R, Roschewski M, Walters KM, Chen CC, Baratto L, Ahlman MA, Miljkovic MD, Steinberg SM, Lam J, Shovlin M, Dunleavy K, Pittaluga S, Jaffe ES, Wilson WH. End-of-treatment and serial PET imaging in primary mediastinal B-cell lymphoma following dose-adjusted EPOCH-R: a paradigm shift in clinical decision making. Haematologica. 2018 Aug;103(8):1337-1344. doi: 10.3324/haematol.2018.192492. Epub 2018 May 10. |
| 25024303 | Derived | Wilson WH, Pittaluga S, Nicolae A, Camphausen K, Shovlin M, Steinberg SM, Roschewski M, Staudt LM, Jaffe ES, Dunleavy K. A prospective study of mediastinal gray-zone lymphoma. Blood. 2014 Sep 4;124(10):1563-9. doi: 10.1182/blood-2014-03-564906. Epub 2014 Jul 14. |
| 24224624 | Derived | Dunleavy K, Pittaluga S, Shovlin M, Steinberg SM, Cole D, Grant C, Widemann B, Staudt LM, Jaffe ES, Little RF, Wilson WH. Low-intensity therapy in adults with Burkitt's lymphoma. N Engl J Med. 2013 Nov 14;369(20):1915-25. doi: 10.1056/NEJMoa1308392. |
| 23574119 | Derived | Dunleavy K, Pittaluga S, Maeda LS, Advani R, Chen CC, Hessler J, Steinberg SM, Grant C, Wright G, Varma G, Staudt LM, Jaffe ES, Wilson WH. Dose-adjusted EPOCH-rituximab therapy in primary mediastinal B-cell lymphoma. N Engl J Med. 2013 Apr 11;368(15):1408-16. doi: 10.1056/NEJMoa1214561. |
| FG001 | EPOCH Alone (Etoposide, Doxorubicin, Prednisone, and Cyclophosphamide) | Subgroup 2 (SG2) - EPOCH alone: All participants who received Prednisone 100mg by mouth (PO) twice a day (bid) on days 1 through 5 every 21 days, and cyclophosphamide 750mg/m^2 on day 5 every 21 days. Doxorubicin 10mg/m^2/day, vincristine 0.4mg/m^2/day, and etoposide 50mg/m^2/day were delivered as continuous intravenous (CIV) infusions over 96 hours starting on day 1 every 21 days. Dose levels were adjusted on doxorubicin, etoposide, and cyclophosphamide each cycle based on neutrophil nadir. |
| FG002 | Enrolled But Not Treated | One participant was enrolled and not treated. |
| Follow-up Period Completed |
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| COMPLETED |
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| NOT COMPLETED |
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Collected baseline data is reported for 1 participant enrolled but not treated.
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| ID | Title | Description |
|---|---|---|
| BG000 | With EPOCH-R (Etoposide, Doxorubicin, Prednisone, Cyclophosphamide and Rituximab) | Subgroup 1 (SG1) - All participants who received combination Rituximab (EPOCH-R). Rituximab 375 mg/m^2 intravenous (IV) on day 1, every 21 days, prednisone 100mg by mouth (PO) twice a day (bid) on days 1 through 5 every 21 days, and cyclophosphamide 750mg/m^2 on day 5 every 21 days. Doxorubicin 10mg/m^2/day, vincristine 0.4mg/m^2/day, and etoposide 50mg/m^2/day were delivered as continuous intravenous (CIV) infusions over 96 hours starting on day 1 every 21 days. Dose levels were adjusted on doxorubicin, etoposide, and cyclophosphamide each cycle based on neutrophil nadir. |
| BG001 | EPOCH Alone (Etoposide, Doxorubicin, Prednisone, and Cyclophosphamide) | Subgroup 2 (SG2) - EPOCH alone: All participants who received Prednisone 100mg by mouth (PO) twice a day (bid) on days 1 through 5 every 21 days, and cyclophosphamide 750mg/m^2 on day 5 every 21 days. Doxorubicin 10mg/m^2/day, vincristine 0.4mg/m^2/day, and etoposide 50mg/m^2/day were delivered as continuous intravenous (CIV) infusions over 96 hours starting on day 1 every 21 days. Dose levels were adjusted on doxorubicin, etoposide, and cyclophosphamide each cycle based on neutrophil nadir. |
| BG002 | Enrolled But Not Treated | Participant was enrolled but not treated. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 (Complete Response + Partial Response) | Overall response defined as a Complete Response + Partial Response was measured by the Response Criteria. Complete Response is disappearance of all signs and symptoms of lymphoma for a period of at least one month. Partial Response is 50% or greater decrease in the sum of the products of the longest perpendicular diameters of all measured lesions lasting for a period of at least one month. | 347/348 participants were analyzed because 1 was inevaluable for response. | Posted | Count of Participants | Participants | Time frame was from beginning of therapy until the end of therapy, an average of 6 months |
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| Primary | Progression Free Survival (PFS) | The Dixon-Simon method will be used to determine whether large B-cell lymphomas expressing BCL-2 (+) participants may experience an improved progression free survival with Etoposide, VP-16, and Doxorubicin with Prednisone, Cyclophosphamide, and Rituximab (EPOCH-R) compared to EPOCH alone, and to obtain a concurrent, precisely determined measure of progression free survival. PFS is the time from start of treatment to documented evidence of disease progression. Progression is an increase of 25% or more in the sum of the products of the longest perpendicular diameters of all measured lesions, or the appearance of any new lesions measured by the Response Criteria. | 347/348 participants were analyzed because 1 was inevaluable for response. | Posted | Count of Participants | Participants | Progression free survival was calculated from study entry until progression or death from any cause. Median follow up of evaluable participants was 5 years (range 2-7 years) |
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| Secondary | Proportion of Participants With Serious and/or Non-serious Adverse Events Leading to Discontinuation of Therapy | Here is the proportion of participants with adverse events leading to discontinuation of therapy. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the participant and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. | 347/348 participants were analyzed because one participant was enrolled and not treated. | Posted | Number | proportion of participants | Initiation of study drug until 30 days after treatment, an average of 6 months |
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| Other Pre-specified | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. | 347/348 participants were analyzed because one participant was enrolled and not treated. | Posted | Count of Participants | Participants | Time frame is from study entry until 30 days after completing study therapy, approximately 5 years. |
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All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years.
347/348 participants were analyzed because one participant was enrolled and not treated.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | With EPOCH-R (Etoposide, Doxorubicin, Prednisone, Cyclophosphamide and Rituximab) | Subgroup 1 (SG1) - All participants who received combination Rituximab (EPOCH-R). Rituximab 375 mg/m^2 intravenous (IV) on day 1, every 21 days, prednisone 100mg by mouth (PO) twice a day (bid) on days 1 through 5 every 21 days, and cyclophosphamide 750mg/m^2 on day 5 every 21 days. Doxorubicin 10mg/m^2/day, vincristine 0.4mg/m^2/day, and etoposide 50mg/m^2/day were delivered as continuous intravenous (CIV) infusions over 96 hours starting on day 1 every 21 days. Dose levels were adjusted on doxorubicin, etoposide, and cyclophosphamide each cycle based on neutrophil nadir. | 28 | 235 | 146 | 235 | 235 | 235 |
| EG001 | EPOCH Alone (Etoposide, Doxorubicin, Prednisone, and Cyclophosphamide) | Subgroup 2 (SG2) - EPOCH alone: All participants who received Prednisone 100mg by mouth (PO) twice a day (bid) on days 1 through 5 every 21 days, and cyclophosphamide 750mg/m^2 on day 5 every 21 days. Doxorubicin 10mg/m^2/day, vincristine 0.4mg/m^2/day, and etoposide 50mg/m^2/day were delivered as continuous intravenous (CIV) infusions over 96 hours starting on day 1 every 21 days. Dose levels were adjusted on doxorubicin, etoposide, and cyclophosphamide each cycle based on neutrophil nadir. | 13 | 112 | 44 | 112 | 112 | 112 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acidosis (metabolic or respiratory) | Metabolism and nutrition disorders | CTC 3.0 | Systematic Assessment |
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| Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | CTC 3.0 | Systematic Assessment |
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| Anorexia | Gastrointestinal disorders | CTC 3.0 | Systematic Assessment |
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| CNS cerebrovascular ischemia | Nervous system disorders | CTC 3.0 | Systematic Assessment |
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| Cardiac ischemia/infarction | Cardiac disorders | CTC 3.0 | Systematic Assessment |
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| Confusion | Nervous system disorders | CTC 3.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTC 3.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | CTC 3.0 | Systematic Assessment |
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| Cytokine release syndrome/acute infusion reaction | General disorders | CTC 3.0 | Systematic Assessment |
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| Dehydration | Gastrointestinal disorders | CTC 3.0 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTC 3.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | CTC 3.0 | Systematic Assessment |
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| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTC 3.0 | Systematic Assessment |
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| Febrile neutropenia | Infections and infestations | CTC 3.0 | Systematic Assessment | (fever of unknown origin without clinically or microbiologically documented infection)(ANC <1.0 x 10e9/L, fever >=38.5 degrees C) |
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| Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | General disorders | CTC 3.0 | Systematic Assessment |
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| Gastrointestinal - Other (Esophageal Obstruction) | Gastrointestinal disorders | CTC 3.0 | Systematic Assessment |
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| Gastrointestinal - Other (Hernia) | Gastrointestinal disorders | CTC 3.0 | Systematic Assessment |
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| Hemoglobin | Blood and lymphatic system disorders | CTC 3.0 | Systematic Assessment |
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| Hemorrhage, CNS | Nervous system disorders | CTC 3.0 | Systematic Assessment |
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| Hemorrhage, GI::Upper GI NOS | Gastrointestinal disorders | CTC 3.0 | Systematic Assessment |
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| Hemorrhage, pulmonary/upper respiratory::Nose | Respiratory, thoracic and mediastinal disorders | CTC 3.0 | Systematic Assessment |
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| Hemorrhage, pulmonary/upper respiratory::Respiratory tract NOS | Respiratory, thoracic and mediastinal disorders | CTC 3.0 | Systematic Assessment |
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| Hypotension | Cardiac disorders | CTC 3.0 | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTC 3.0 | Systematic Assessment |
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| Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation) | Gastrointestinal disorders | CTC 3.0 | Systematic Assessment |
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| Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils | Infections and infestations | CTC 3.0 | Systematic Assessment | (ANC <1.0 x 10e9/L)::Blood |
|
| Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils | Infections and infestations | CTC 3.0 | Systematic Assessment | (ANC <1.0 x 10e9/L)::Joint |
|
| Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils | Infections and infestations | CTC 3.0 | Systematic Assessment | (ANC <1.0 x 10e9/L)::Lung (pneumonia) |
|
| Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils | Infections and infestations | CTC 3.0 | Systematic Assessment | (ANC <1.0 x 10e9/L)::Skin (cellulitis) |
|
| Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils | Infections and infestations | CTC 3.0 | Systematic Assessment | (ANC <1.0 x 10e9/L)::Small bowel NOS |
|
| Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils | Infections and infestations | CTC 3.0 | Systematic Assessment | (ANC <1.0 x 10e9/L)::Upper airway NOS |
|
| Infection with normal ANC or Grade 1 or 2 neutrophils::Blood | Infections and infestations | CTC 3.0 | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Lung (pneumonia) | Infections and infestations | CTC 3.0 | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Rectum | Infections and infestations | CTC 3.0 | Systematic Assessment |
| |
| Infection with unknown ANC::Urinary tract NOS | Infections and infestations | CTC 3.0 | Systematic Assessment |
| |
| Leukocytes (total WBC) | Blood and lymphatic system disorders | CTC 3.0 | Systematic Assessment |
| |
| Liver dysfunction/failure (clinical) | Hepatobiliary disorders | CTC 3.0 | Systematic Assessment |
| |
| Magnesium, serum-low (hypomagnesemia) | Metabolism and nutrition disorders | CTC 3.0 | Systematic Assessment |
| |
| Mucositis/stomatitis (clinical exam)::Oral cavity | Gastrointestinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Muscle weakness, generalized or specific area (not due to neuropathy)::Whole body/generalized | Musculoskeletal and connective tissue disorders | CTC 3.0 | Systematic Assessment |
| |
| Musculoskeletal/Soft Tissue - Other (Hip fracture) | Musculoskeletal and connective tissue disorders | CTC 3.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Neurology - Other (subdural hygroma) | Nervous system disorders | CTC 3.0 | Systematic Assessment |
| |
| Neuropathy: cranial::CN VII Motor-face; Sensory-taste | Nervous system disorders | CTC 3.0 | Systematic Assessment |
| |
| Neuropathy: motor | Nervous system disorders | CTC 3.0 | Systematic Assessment |
| |
| Neuropathy: sensory | Nervous system disorders | CTC 3.0 | Systematic Assessment |
| |
| Neutrophils/granulocytes (ANC/AGC) | Investigations | CTC 3.0 | Systematic Assessment |
| |
| PTT (Partial Thromboplastin Time) | Blood and lymphatic system disorders | CTC 3.0 | Systematic Assessment |
| |
| Pain - Other (Incision) | Skin and subcutaneous tissue disorders | CTC 3.0 | Systematic Assessment |
| |
| Pain::Abdomen NOS | Gastrointestinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Pain::Bone | Musculoskeletal and connective tissue disorders | CTC 3.0 | Systematic Assessment |
| |
| Pain::Chest/thorax NOS | Musculoskeletal and connective tissue disorders | CTC 3.0 | Systematic Assessment |
| |
| Pain::Head/headache | Nervous system disorders | CTC 3.0 | Systematic Assessment |
| |
| Pain::Muscle | Musculoskeletal and connective tissue disorders | CTC 3.0 | Systematic Assessment |
| |
| Pancreatitis | Hepatobiliary disorders | CTC 3.0 | Systematic Assessment |
| |
| Perforation, GI::Duodenum | Gastrointestinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Perforation, GI::Esophagus | Gastrointestinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Perforation, GI::Small bowel NOS | Gastrointestinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Perforation, GI::Stomach | Gastrointestinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Platelets | Blood and lymphatic system disorders | CTC 3.0 | Systematic Assessment |
| |
| Potassium, serum-low (hypokalemia) | Metabolism and nutrition disorders | CTC 3.0 | Systematic Assessment |
| |
| Rash: dermatitis associated with radiation::Radiation | Skin and subcutaneous tissue disorders | CTC 3.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | CTC 3.0 | Systematic Assessment |
| |
| Rigors/chills | General disorders | CTC 3.0 | Systematic Assessment |
| |
| Secondary Malignancy - possibly related to cancer treatment (Specify, __) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTC 3.0 | Systematic Assessment |
| |
| Supraventricular and nodal arrhythmia::Sinus arrhythmia | Cardiac disorders | CTC 3.0 | Systematic Assessment |
| |
| Supraventricular and nodal arrhythmia::Sinus tachycardia | Cardiac disorders | CTC 3.0 | Systematic Assessment |
| |
| Syncope (fainting) | Nervous system disorders | CTC 3.0 | Systematic Assessment |
| |
| Thrombosis/thrombus/embolism | Vascular disorders | CTC 3.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTC 3.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | CTC 3.0 | Systematic Assessment |
| |
| AST, SGOT(serum glutamic oxaloacetic transaminase) | Metabolism and nutrition disorders | CTC 3.0 | Systematic Assessment |
| |
| Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | CTC 3.0 | Systematic Assessment |
| |
| Alkaline phosphatase | Metabolism and nutrition disorders | CTC 3.0 | Systematic Assessment |
| |
| Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | CTC 3.0 | Systematic Assessment |
| |
| Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | Immune system disorders | CTC 3.0 | Systematic Assessment |
| |
| Amylase | Metabolism and nutrition disorders | CTC 3.0 | Systematic Assessment |
| |
| Anorexia | Gastrointestinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Arthritis (non-septic) | Musculoskeletal and connective tissue disorders | CTC 3.0 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Auditory/Ear - Other (decreased hearing) | Ear and labyrinth disorders | CTC 3.0 | Systematic Assessment |
| |
| Bicarbonate, serum-low | Metabolism and nutrition disorders | CTC 3.0 | Systematic Assessment |
| |
| Bilirubin (hyperbilirubinemia) | Metabolism and nutrition disorders | CTC 3.0 | Systematic Assessment |
| |
| Bronchospasm, wheezing | Respiratory, thoracic and mediastinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Bruising (in absence of Grade 3 or 4 thrombocytopenia) | Skin and subcutaneous tissue disorders | CTC 3.0 | Systematic Assessment |
| |
| CNS cerebrovascular ischemia | Nervous system disorders | CTC 3.0 | Systematic Assessment |
| |
| CPK (creatine phosphokinase) | Metabolism and nutrition disorders | CTC 3.0 | Systematic Assessment |
| |
| Calcium, serum-high (hypercalcemia) | Metabolism and nutrition disorders | CTC 3.0 | Systematic Assessment |
| |
| Calcium, serum-low (hypocalcemia) | Metabolism and nutrition disorders | CTC 3.0 | Systematic Assessment |
| |
| Cardiac General - Other (Fluid overload) | Cardiac disorders | CTC 3.0 | Systematic Assessment |
| |
| Cardiac ischemia/infarction | Cardiac disorders | CTC 3.0 | Systematic Assessment |
| |
| Cognitive disturbance | Nervous system disorders | CTC 3.0 | Systematic Assessment |
| |
| Colitis, infectious (e.g., Clostridium difficile) | Gastrointestinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Confusion | Nervous system disorders | CTC 3.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Constitutional Symptoms - Other (Intolerance to cold) | General disorders | CTC 3.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Creatinine | Metabolism and nutrition disorders | CTC 3.0 | Systematic Assessment |
| |
| Cystitis | Renal and urinary disorders | CTC 3.0 | Systematic Assessment |
| |
| DIC (disseminated intravascular coagulation) | Blood and lymphatic system disorders | CTC 3.0 | Systematic Assessment |
| |
| Dehydration | Gastrointestinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Dermatology/Skin - Other (Blisters-toes) | Skin and subcutaneous tissue disorders | CTC 3.0 | Systematic Assessment |
| |
| Dermatology/Skin - Other (Cold sore) | Skin and subcutaneous tissue disorders | CTC 3.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Distension/bloating, abdominal | Gastrointestinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTC 3.0 | Systematic Assessment |
| |
| Dry eye syndrome | Eye disorders | CTC 3.0 | Systematic Assessment |
| |
| Dry mouth/salivary gland (xerostomia) | Gastrointestinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTC 3.0 | Systematic Assessment |
| |
| Dysphagia (difficulty swallowing) | Gastrointestinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Edema: limb | Blood and lymphatic system disorders | CTC 3.0 | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | CTC 3.0 | Systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Extrapyramidal/involuntary movement/restlessness | Nervous system disorders | CTC 3.0 | Systematic Assessment |
| |
| Fatigue (asthenia, lethargy, malaise) | General disorders | CTC 3.0 | Systematic Assessment |
| |
| Febrile neutropenia | Infections and infestations | CTC 3.0 | Systematic Assessment | (fever of unknown origin without clinically or microbiologically documented infection) (ANC <1.0 x 10e9/L, fever >=38.5 degrees C) |
|
| Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | General disorders | CTC 3.0 | Systematic Assessment |
| |
| Fistula, GI::Rectum | Gastrointestinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Flushing | Skin and subcutaneous tissue disorders | CTC 3.0 | Systematic Assessment |
| |
| GGT (gamma-Glutamyl transpeptidase) | Metabolism and nutrition disorders | CTC 3.0 | Systematic Assessment |
| |
| Gastritis (including bile reflux gastritis) | Gastrointestinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Gastrointestinal - Other (Bloating) | Gastrointestinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Gastrointestinal - Other (Early satiety) | Gastrointestinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Gastrointestinal - Other (Esophageal Stenosis) | Gastrointestinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Gastrointestinal - Other (Hernia) | Gastrointestinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Glucose, serum-high (hyperglycemia) | Metabolism and nutrition disorders | CTC 3.0 | Systematic Assessment |
| |
| Glucose, serum-low (hypoglycemia) | Metabolism and nutrition disorders | CTC 3.0 | Systematic Assessment |
| |
| Hair loss/alopecia (scalp or body) | Skin and subcutaneous tissue disorders | CTC 3.0 | Systematic Assessment |
| |
| Hearing: patients with/without baseline audiogram and enrolled in a monitoring program | Ear and labyrinth disorders | CTC 3.0 | Systematic Assessment |
| |
| Hearing: patients without baseline audiogram and not enrolled in a monitoring program | Ear and labyrinth disorders | CTC 3.0 | Systematic Assessment |
| |
| Heartburn/dyspepsia | Gastrointestinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | CTC 3.0 | Systematic Assessment |
| |
| Hemorrhage, GI::Anus | Gastrointestinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Hemorrhage, GI::Oral cavity | Gastrointestinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Hemorrhage, GI::Rectum | Gastrointestinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Hemorrhage, GI::Upper GI NOS | Gastrointestinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Hemorrhage, GI::Varices (rectal) | Gastrointestinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Hemorrhage, GU::Urethra | Renal and urinary disorders | CTC 3.0 | Systematic Assessment |
| |
| Hemorrhage, GU::Urinary NOS | Renal and urinary disorders | CTC 3.0 | Systematic Assessment |
| |
| Hemorrhage, GU::Vagina | Reproductive system and breast disorders | CTC 3.0 | Systematic Assessment |
| |
| Hemorrhage, pulmonary/upper respiratory::Bronchopulmonary NOS | Respiratory, thoracic and mediastinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Hemorrhage, pulmonary/upper respiratory::Nose | Respiratory, thoracic and mediastinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Hemorrhage, pulmonary/upper respiratory::Respiratory tract NOS | Respiratory, thoracic and mediastinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Hemorrhage/Bleeding - Other (Ecchymosis) | Skin and subcutaneous tissue disorders | CTC 3.0 | Systematic Assessment |
| |
| Hemorrhage/Bleeding - Other (Gluteal muscle;Compartment syndrome) | Musculoskeletal and connective tissue disorders | CTC 3.0 | Systematic Assessment |
| |
| Hemorrhoids | Blood and lymphatic system disorders | CTC 3.0 | Systematic Assessment |
| |
| Hiccoughs (hiccups, singultus) | Respiratory, thoracic and mediastinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Hot flashes/flushes | Endocrine disorders | CTC 3.0 | Systematic Assessment |
| |
| Hyperpigmentation | Skin and subcutaneous tissue disorders | CTC 3.0 | Systematic Assessment |
| |
| Hypertension | Cardiac disorders | CTC 3.0 | Systematic Assessment |
| |
| Hypopigmentation | Skin and subcutaneous tissue disorders | CTC 3.0 | Systematic Assessment |
| |
| Hypotension | Cardiac disorders | CTC 3.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation) | Gastrointestinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Incontinence, urinary | Renal and urinary disorders | CTC 3.0 | Systematic Assessment |
| |
| Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils | Infections and infestations | CTC 3.0 | Systematic Assessment | (ANC <1.0 x 10e9/L)::Bladder (urinary) |
|
| Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils | Infections and infestations | CTC 3.0 | Systematic Assessment | (ANC <1.0 x 10e9/L)::Blood |
|
| Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils | Infections and infestations | CTC 3.0 | Systematic Assessment | (ANC <1.0 x 10e9/L)::External ear (otitis externa) |
|
| Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils | Infections and infestations | CTC 3.0 | Systematic Assessment | (ANC <1.0 x 10e9/L)::Lung (pneumonia) |
|
| Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils | Infections and infestations | CTC 3.0 | Systematic Assessment | (ANC <1.0 x 10e9/L)::Mucosa |
|
| Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils | Infections and infestations | CTC 3.0 | Systematic Assessment | (ANC <1.0 x 10e9/L)::Pelvis NOS |
|
| Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils | Infections and infestations | CTC 3.0 | Systematic Assessment | (ANC <1.0 x 10e9/L)::Rectum |
|
| Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils | Infections and infestations | CTC 3.0 | Systematic Assessment | (ANC <1.0 x 10e9/L)::Skin (cellulites) |
|
| Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils | Infections and infestations | CTC 3.0 | Systematic Assessment | (ANC <1.0 x 10e9/L)::Soft tissue NOS |
|
| Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils | Infections and infestations | CTC 3.0 | Systematic Assessment | (ANC <1.0 x 10e9/L)::Stomach |
|
| Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils | Infections and infestations | CTC 3.0 | Systematic Assessment | (ANC <1.0 x 10e9/L)::Upper airway NOS |
|
| Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils | Infections and infestations | CTC 3.0 | Systematic Assessment | (ANC <1.0 x 10e9/L)::Urinary tract NOS |
|
| Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils | Infections and infestations | CTC 3.0 | Systematic Assessment | (ANC <1.0 x 10e9/L)::Vagina |
|
| Infection - Other (PAC; blood-yeast) | Infections and infestations | CTC 3.0 | Systematic Assessment |
| |
| Infection - Other (R axilla) | Infections and infestations | CTC 3.0 | Systematic Assessment |
| |
| Infection - Other (foot - tinea pedis) | Infections and infestations | CTC 3.0 | Systematic Assessment |
| |
| Infection - Other (fungal, tinea pedis) | Infections and infestations | CTC 3.0 | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Abdomen NOS | Infections and infestations | CTC 3.0 | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Blood | Infections and infestations | CTC 3.0 | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Catheter-related | Infections and infestations | CTC 3.0 | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Colon | Infections and infestations | CTC 3.0 | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Conjunctiva | Infections and infestations | CTC 3.0 | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::External ear (otitis externa) | Infections and infestations | CTC 3.0 | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Eye NOS | Infections and infestations | CTC 3.0 | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Lip/perioral | Infections and infestations | CTC 3.0 | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Liver | Infections and infestations | CTC 3.0 | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Lung (pneumonia) | Infections and infestations | CTC 3.0 | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Middle ear (otitis media) | Infections and infestations | CTC 3.0 | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Mucosa | Infections and infestations | CTC 3.0 | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Nerve-peripheral | Infections and infestations | CTC 3.0 | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Nose | Infections and infestations | CTC 3.0 | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Rectum | Infections and infestations | CTC 3.0 | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Salivary gland | Infections and infestations | CTC 3.0 | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Scrotum | Infections and infestations | CTC 3.0 | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Sinus | Infections and infestations | CTC 3.0 | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Skin (cellulitis) | Infections and infestations | CTC 3.0 | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Small bowel NOS | Infections and infestations | CTC 3.0 | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Ungual (nails) | Infections and infestations | CTC 3.0 | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Upper aerodigestive NOS | Infections and infestations | CTC 3.0 | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Upper airway NOS | Infections and infestations | CTC 3.0 | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS | Infections and infestations | CTC 3.0 | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Vagina | Infections and infestations | CTC 3.0 | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Wound | Infections and infestations | CTC 3.0 | Systematic Assessment |
| |
| Infection with unknown ANC::Blood | Infections and infestations | CTC 3.0 | Systematic Assessment |
| |
| Infection with unknown ANC::Conjunctiva | Infections and infestations | CTC 3.0 | Systematic Assessment |
| |
| Infection with unknown ANC::Rectum | Infections and infestations | CTC 3.0 | Systematic Assessment |
| |
| Infection with unknown ANC::Urinary tract NOS | Infections and infestations | CTC 3.0 | Systematic Assessment |
| |
| Injection site reaction/extravasation changes | Skin and subcutaneous tissue disorders | CTC 3.0 | Systematic Assessment |
| |
| Insomnia | Gastrointestinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Irregular menses (change from baseline) | Reproductive system and breast disorders | CTC 3.0 | Systematic Assessment |
| |
| Leukocytes (total WBC) | Blood and lymphatic system disorders | CTC 3.0 | Systematic Assessment |
| |
| Lipase | Metabolism and nutrition disorders | CTC 3.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | CTC 3.0 | Systematic Assessment |
| |
| Magnesium, serum-high (hypermagnesemia) | Metabolism and nutrition disorders | CTC 3.0 | Systematic Assessment |
| |
| Magnesium, serum-low (hypomagnesemia) | Metabolism and nutrition disorders | CTC 3.0 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | CTC 3.0 | Systematic Assessment |
| |
| Mood alteration::Agitation | Nervous system disorders | CTC 3.0 | Systematic Assessment |
| |
| Mood alteration::Anxiety | Nervous system disorders | CTC 3.0 | Systematic Assessment |
| |
| Mood alteration::Depression | Nervous system disorders | CTC 3.0 | Systematic Assessment |
| |
| Mucositis/stomatitis (clinical exam)::Large bowel | Gastrointestinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Mucositis/stomatitis (clinical exam)::Larynx | Gastrointestinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Mucositis/stomatitis (clinical exam)::Oral cavity | Gastrointestinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Mucositis/stomatitis (clinical exam)::Stomach | Gastrointestinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Mucositis/stomatitis (functional/symptomatic)::Oral cavity | Gastrointestinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Muscle weakness, generalized or specific area (not due to neuropathy)::Extremity-lower | Musculoskeletal and connective tissue disorders | CTC 3.0 | Systematic Assessment |
| |
| Muscle weakness, generalized or specific area (not due to neuropathy)::Whole body/generalized | Musculoskeletal and connective tissue disorders | CTC 3.0 | Systematic Assessment |
| |
| Musculoskeletal/Soft Tissue - Other (Finger injury) | Musculoskeletal and connective tissue disorders | CTC 3.0 | Systematic Assessment |
| |
| Musculoskeletal/Soft Tissue - Other (Hand cramps) | Musculoskeletal and connective tissue disorders | CTC 3.0 | Systematic Assessment |
| |
| Musculoskeletal/Soft Tissue - Other (Hip fracture) | Musculoskeletal and connective tissue disorders | CTC 3.0 | Systematic Assessment |
| |
| Musculoskeletal/Soft Tissue - Other (Spasms) | Musculoskeletal and connective tissue disorders | CTC 3.0 | Systematic Assessment |
| |
| Musculoskeletal/Soft Tissue - Other (Sprain) | Musculoskeletal and connective tissue disorders | CTC 3.0 | Systematic Assessment |
| |
| Nail changes | Skin and subcutaneous tissue disorders | CTC 3.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Neurology - Other (antonomic neuropathy) | Nervous system disorders | CTC 3.0 | Systematic Assessment |
| |
| Neuropathy: motor | Nervous system disorders | CTC 3.0 | Systematic Assessment |
| |
| Neuropathy: sensory | Nervous system disorders | CTC 3.0 | Systematic Assessment |
| |
| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | CTC 3.0 | Systematic Assessment |
| |
| Obstruction, GI::Small bowel NOS | Gastrointestinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Ocular/Visual - Other (Red eye) | Eye disorders | CTC 3.0 | Systematic Assessment |
| |
| Ocular/Visual - Other (Uveitis) | Eye disorders | CTC 3.0 | Systematic Assessment |
| |
| Ophthalmoplegia/diplopia (double vision) | Eye disorders | CTC 3.0 | Systematic Assessment |
| |
| PTT (Partial Thromboplastin Time) | Blood and lymphatic system disorders | CTC 3.0 | Systematic Assessment |
| |
| Pain - Other (Biopsy site) | General disorders | CTC 3.0 | Systematic Assessment |
| |
| Pain - Other (Epigastric) | Gastrointestinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Pain - Other (Flank) | Musculoskeletal and connective tissue disorders | CTC 3.0 | Systematic Assessment |
| |
| Pain - Other (Groin) | Reproductive system and breast disorders | CTC 3.0 | Systematic Assessment |
| |
| Pain - Other (Lung) | Respiratory, thoracic and mediastinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Pain - Other (Ribs) | Musculoskeletal and connective tissue disorders | CTC 3.0 | Systematic Assessment |
| |
| Pain - Other (VAD site) | General disorders | CTC 3.0 | Systematic Assessment |
| |
| Pain::Abdomen NOS | Gastrointestinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Pain::Back | Musculoskeletal and connective tissue disorders | CTC 3.0 | Systematic Assessment |
| |
| Pain::Bladder | Renal and urinary disorders | CTC 3.0 | Systematic Assessment |
| |
| Pain::Bone | Musculoskeletal and connective tissue disorders | CTC 3.0 | Systematic Assessment |
| |
| Pain::Breast | Reproductive system and breast disorders | CTC 3.0 | Systematic Assessment |
| |
| Pain::Buttock | Musculoskeletal and connective tissue disorders | CTC 3.0 | Systematic Assessment |
| |
| Pain::Chest wall | Musculoskeletal and connective tissue disorders | CTC 3.0 | Systematic Assessment |
| |
| Pain::Chest/thorax NOS | Musculoskeletal and connective tissue disorders | CTC 3.0 | Systematic Assessment |
| |
| Pain::Dental/teeth/peridontal | Gastrointestinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Pain::External ear | Ear and labyrinth disorders | CTC 3.0 | Systematic Assessment |
| |
| Pain::Extremity-limb | Musculoskeletal and connective tissue disorders | CTC 3.0 | Systematic Assessment |
| |
| Pain::Eye | Eye disorders | CTC 3.0 | Systematic Assessment |
| |
| Pain::Face | Skin and subcutaneous tissue disorders | CTC 3.0 | Systematic Assessment |
| |
| Pain::Head/headache | Nervous system disorders | CTC 3.0 | Systematic Assessment |
| |
| Pain::Joint | Musculoskeletal and connective tissue disorders | CTC 3.0 | Systematic Assessment |
| |
| Pain::Larynx | Respiratory, thoracic and mediastinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Pain::Middle ear | Ear and labyrinth disorders | CTC 3.0 | Systematic Assessment |
| |
| Pain::Muscle | Musculoskeletal and connective tissue disorders | CTC 3.0 | Systematic Assessment |
| |
| Pain::Neck | Musculoskeletal and connective tissue disorders | CTC 3.0 | Systematic Assessment |
| |
| Pain::Neuralgia/peripheral nerve | Nervous system disorders | CTC 3.0 | Systematic Assessment |
| |
| Pain::Oral cavity | Gastrointestinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Pain::Pain NOS | General disorders | CTC 3.0 | Systematic Assessment |
| |
| Pain::Pelvis | Reproductive system and breast disorders | CTC 3.0 | Systematic Assessment |
| |
| Pain::Rectum | Gastrointestinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Pain::Throat/pharynx/larynx | Respiratory, thoracic and mediastinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Pain::Urethra | Renal and urinary disorders | CTC 3.0 | Systematic Assessment |
| |
| Pain::Vagina | Reproductive system and breast disorders | CTC 3.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | CTC 3.0 | Systematic Assessment |
| |
| Pericardial effusion (non-malignant) | Cardiac disorders | CTC 3.0 | Systematic Assessment |
| |
| Petechiae/purpura (hemorrhage/bleeding into skin or mucosa) | Blood and lymphatic system disorders | CTC 3.0 | Systematic Assessment |
| |
| Phlebitis (including superficial thrombosis) | Vascular disorders | CTC 3.0 | Systematic Assessment |
| |
| Phosphate, serum-low (hypophosphatemia) | Metabolism and nutrition disorders | CTC 3.0 | Systematic Assessment |
| |
| Platelets | Blood and lymphatic system disorders | CTC 3.0 | Systematic Assessment |
| |
| Pleural effusion (non-malignant) | Respiratory, thoracic and mediastinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Pneumonitis/pulmonary infiltrates | Respiratory, thoracic and mediastinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Potassium, serum-high (hyperkalemia) | Metabolism and nutrition disorders | CTC 3.0 | Systematic Assessment |
| |
| Potassium, serum-low (hypokalemia) | Metabolism and nutrition disorders | CTC 3.0 | Systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Proteinuria | Metabolism and nutrition disorders | CTC 3.0 | Systematic Assessment |
| |
| Pruritus/itching | Skin and subcutaneous tissue disorders | CTC 3.0 | Systematic Assessment |
| |
| Psychosis (hallucinations/delusions) | Nervous system disorders | CTC 3.0 | Systematic Assessment |
| |
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTC 3.0 | Systematic Assessment |
| |
| Rash: acne/acneiform | Skin and subcutaneous tissue disorders | CTC 3.0 | Systematic Assessment |
| |
| Rash: hand-foot skin reaction | Skin and subcutaneous tissue disorders | CTC 3.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | CTC 3.0 | Systematic Assessment |
| |
| Renal/Genitourinary - Other (Nocturia) | Renal and urinary disorders | CTC 3.0 | Systematic Assessment |
| |
| Renal/Genitourinary - Other (dysuria) | Renal and urinary disorders | CTC 3.0 | Systematic Assessment |
| |
| Rigors/chills | General disorders | CTC 3.0 | Systematic Assessment |
| |
| Secondary Malignancy - possibly related to cancer treatment (Specify, __) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTC 3.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | CTC 3.0 | Systematic Assessment |
| |
| Skin breakdown/decubitus ulcer | Skin and subcutaneous tissue disorders | CTC 3.0 | Systematic Assessment |
| |
| Sodium, serum-high (hypernatremia) | Metabolism and nutrition disorders | CTC 3.0 | Systematic Assessment |
| |
| Sodium, serum-low (hyponatremia) | Metabolism and nutrition disorders | CTC 3.0 | Systematic Assessment |
| |
| Somnolence/depressed level of consciousness | Nervous system disorders | CTC 3.0 | Systematic Assessment |
| |
| Speech impairment (e.g., dysphasia or aphasia) | Nervous system disorders | CTC 3.0 | Systematic Assessment |
| |
| Supraventricular and nodal arrhythmia::Atrial fibrillation | Cardiac disorders | CTC 3.0 | Systematic Assessment |
| |
| Supraventricular and nodal arrhythmia::Sinus arrhythmia | Cardiac disorders | CTC 3.0 | Systematic Assessment |
| |
| Supraventricular and nodal arrhythmia::Sinus bradycardia | Cardiac disorders | CTC 3.0 | Systematic Assessment |
| |
| Supraventricular and nodal arrhythmia::Sinus tachycardia | Cardiac disorders | CTC 3.0 | Systematic Assessment |
| |
| Supraventricular and nodal arrhythmia::Supraventricular arrhythmia NOS | Cardiac disorders | CTC 3.0 | Systematic Assessment |
| |
| Sweating (diaphoresis) | General disorders | CTC 3.0 | Systematic Assessment |
| |
| Syncope (fainting) | Nervous system disorders | CTC 3.0 | Systematic Assessment |
| |
| Syndromes - Other (Akathisia) | Nervous system disorders | CTC 3.0 | Systematic Assessment |
| |
| Taste alteration (dysgeusia) | Gastrointestinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Thrombosis/embolism (vascular access-related) | Vascular disorders | CTC 3.0 | Systematic Assessment |
| |
| Thrombosis/thrombus/embolism | Vascular disorders | CTC 3.0 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | CTC 3.0 | Systematic Assessment |
| |
| Tumor lysis syndrome | General disorders | CTC 3.0 | Systematic Assessment |
| |
| Uric acid, serum-high (hyperuricemia) | Metabolism and nutrition disorders | CTC 3.0 | Systematic Assessment |
| |
| Urinary frequency/urgency | Renal and urinary disorders | CTC 3.0 | Systematic Assessment |
| |
| Urinary retention (including neurogenic bladder) | Renal and urinary disorders | CTC 3.0 | Systematic Assessment |
| |
| Urine color change | Renal and urinary disorders | CTC 3.0 | Systematic Assessment |
| |
| Urticaria (hives, welts, wheals) | Skin and subcutaneous tissue disorders | CTC 3.0 | Systematic Assessment |
| |
| Vaginal discharge (non-infectious) | Reproductive system and breast disorders | CTC 3.0 | Systematic Assessment |
| |
| Vasovagal episode | Cardiac disorders | CTC 3.0 | Systematic Assessment |
| |
| Ventricular arrhythmia::Ventricular arrhythmia NOS | Cardiac disorders | CTC 3.0 | Systematic Assessment |
| |
| Vision-blurred vision | Eye disorders | CTC 3.0 | Systematic Assessment |
| |
| Vision-flashing lights/floaters | Eye disorders | CTC 3.0 | Systematic Assessment |
| |
| Vision-photophobia | Eye disorders | CTC 3.0 | Systematic Assessment |
| |
| Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis) | Respiratory, thoracic and mediastinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTC 3.0 | Systematic Assessment |
| |
| Watery eye (epiphora, tearing) | Eye disorders | CTC 3.0 | Systematic Assessment |
| |
| Weight gain | General disorders | CTC 3.0 | Systematic Assessment |
| |
| Weight loss | General disorders | CTC 3.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mark J. Roschewski | National Cancer Institute | 240-760-6183 | mark.roschewski@nih.gov |
| Apr 11, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 2, 2021 | Apr 11, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D002051 | Burkitt Lymphoma |
| D017728 | Lymphoma, Large-Cell, Anaplastic |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| 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 |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D016399 | Lymphoma, T-Cell |
Not provided
Not provided
| ID | Term |
|---|---|
| D005047 | Etoposide |
| D000069283 | Rituximab |
| D011241 | Prednisone |
| D003520 | Cyclophosphamide |
| D014750 | Vincristine |
| D004317 | Doxorubicin |
| C506643 | liposomal doxorubicin |
| D008279 | Magnetic Resonance Imaging |
| D014057 | Tomography, X-Ray Computed |
| D001706 | Biopsy |
| D049268 | Positron-Emission Tomography |
| D007813 | Laparotomy |
| D017294 | Ondansetron |
| D011346 | Prochlorperazine |
| D009853 | Omeprazole |
| C494109 | omeprazole, sodium bicarbonate drug combination |
| D004143 | Dioctyl Sulfosuccinic Acid |
| D000081226 | Sennosides |
| C011803 | doxidan |
| D007792 | Lactulose |
| ID | Term |
|---|---|
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| 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 |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D000617 | Aminoglycosides |
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D007090 | Image Interpretation, Computer-Assisted |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D014055 | Tomography, Emission-Computed |
| D011877 | Radionuclide Imaging |
| D003947 | Diagnostic Techniques, Radioisotope |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D002227 | Carbazoles |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D010640 | Phenothiazines |
| D013457 | Sulfur Compounds |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D011725 | Pyridines |
| D001562 | Benzimidazoles |
| D013386 | Succinates |
| D003998 | Dicarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D012676 | Senna Extract |
| D000880 | Anthraquinones |
| D000095322 | Anthrones |
| D000873 | Anthracenes |
| D011809 | Quinones |
| D010936 | Plant Extracts |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D000073893 | Sugars |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG001 | EPOCH Alone (Etoposide, Doxorubicin, Prednisone, and Cyclophosphamide) | Subgroup 2 (SG2) - EPOCH alone: All participants who received Prednisone 100mg by mouth (PO) twice a day (bid) on days 1 through 5 every 21 days, and cyclophosphamide 750mg/m^2 on day 5 every 21 days. Doxorubicin 10mg/m^2/day, vincristine 0.4mg/m^2/day, and etoposide 50mg/m^2/day were delivered as continuous intravenous (CIV) infusions over 96 hours starting on day 1 every 21 days. Dose levels were adjusted on doxorubicin, etoposide, and cyclophosphamide each cycle based on neutrophil nadir. |
|
|
| EPOCH Alone (Etoposide, Doxorubicin, Prednisone, and Cyclophosphamide) |
Subgroup 2 (SG2) - EPOCH alone: All participants who received Prednisone 100mg by mouth (PO) twice a day (bid) on days 1 through 5 every 21 days, and cyclophosphamide 750mg/m^2 on day 5 every 21 days. Doxorubicin 10mg/m^2/day, vincristine 0.4mg/m^2/day, and etoposide 50mg/m^2/day were delivered as continuous intravenous (CIV) infusions over 96 hours starting on day 1 every 21 days. Dose levels were adjusted on doxorubicin, etoposide, and cyclophosphamide each cycle based on neutrophil nadir. |
|
|
| OG001 | EPOCH Alone (Etoposide, Doxorubicin, Prednisone, and Cyclophosphamide) | Subgroup 2 (SG2) - EPOCH alone: All participants who received Prednisone 100mg by mouth (PO) twice a day (bid) on days 1 through 5 every 21 days, and cyclophosphamide 750mg/m^2 on day 5 every 21 days. Doxorubicin 10mg/m^2/day, vincristine 0.4mg/m^2/day, and etoposide 50mg/m^2/day were delivered as continuous intravenous (CIV) infusions over 96 hours starting on day 1 every 21 days. Dose levels were adjusted on doxorubicin, etoposide, and cyclophosphamide each cycle based on neutrophil nadir. |
|
|