Combination Chemotx in Treating Children or Adolescents W... | NCT00004228 | Trialant
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Studies Combination Chemotx in Treating Children or Adolescents With Newly Diagnosed Stg III or Stg IV Lymphoblastic Lymphoma NCT00004228 Show options Children's Oncology Group
asparaginase cyclophosphamide cytarabine daunorubicin hydrochloride dexamethasone doxorubicin hydrochloride leucovorin calcium mercaptopurine methotrexate prednisone thioguanine vincristine sulfate radiation therapy United States Australia Canada Puerto Rico Switzerland
Obsolete or Duplicate NCT IDs Not provided
ID Type Description Link CCG-59701 Other Identifier Children's Cancer Group CCG-59701C Other Identifier Children's Cancer Group CCG-A5971 Other Identifier Children's Cancer Group POG-A5971 Other Identifier Pediatric Oncology Group CDR0000067470 Other Identifier Clinical Trials.gov
Combination Chemotx in Treating Children or Adolescents With Newly Diagnosed Stg III or Stg IV Lymphoblastic Lymphoma
Randomized Phase III Study for the Treatment of Newly Diagnosed Disseminated Lymphoblastic Lymphoma or Localized Lymphoblastic Lymphoma
Children's Oncology Group NETWORK
Overall Recruitment Status or Expanded Access Status Completed
First Submission Date that Met QC Criteria Jan 26, 2003
Results First Submitted Date Oct 8, 2013
Results First Submitted that Met QC Criteria Oct 8, 2013
Results First Posted Date Dec 5, 2013 Estimated
Certification/Extension (aka Delayed Results) First Submitted Date Not provided
Certification/Extension First Submitted that Passed QC Review Not provided
Certification/Extension First Posted Date Not provided
Last Update Submitted Date Jul 24, 2019
Responsible Party, by Official Title Sponsor
Children's Oncology Group NETWORK
Name Class National Cancer Institute (NCI) NIH
Has Data Monitoring Committee (DMC) Yes
Pediatric Postmarket Surveillance of a Device Product Not provided
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known which regimen of combination chemotherapy is most effective for lymphoblastic lymphoma.
PURPOSE: This randomized phase III trial is studying different regimens of combination chemotherapy to compare how well they work in treating children or adolescents with newly diagnosed stage III or stage IV lymphoblastic lymphoma.
OBJECTIVES:
Compare the event-free survival and overall survival of children or adolescents with newly diagnosed disseminated stage III or IV lymphoblastic lymphoma treated with 4 chemotherapy regimens*.
Determine whether treatment with a regimen without methotrexate maintains the same disease-free survival as NHL/BFM 90 in these patients.
Determine whether intensification with anthracycline and cyclophosphamide improves disease-free survival in these patients.
Collect outcome data on uniformly treated patients with localized disease or CNS-positive disease.
Determine whether rapid reduction in tumor volume by chest radiography and CT scan is predictive of improved outcome in patients treated with these regimens.
Determine the prevalence of bone marrow involvement at presentation in these patients.
Determine whether peripheral blood can replace bone marrow in the initial staging of these patients.
Determine the clinical significance of bone marrow and peripheral blood involvement in these patients.
NOTE: *All patients as of 4/2006 receive treatment on Arm III regimen only
OUTLINE: Patients are stratified by disease characteristics (disseminated lymphoblastic lymphoma vs localized lymphoblastic lymphoma [localized lymphoblastic lymphoma is closed to accrual as of 10/2005]) and age. Patients with CNS negative disseminated lymphoblastic lymphoma are randomized to 1 of 4 treatment arms*. Patients with testicular involvement at diagnosis are nonrandomly assigned to arm IV and do not receive testicular radiotherapy. Patients with localized lymphoblastic lymphoma (closed to accrual as of 10/2005) are not randomized.
NOTE: *All patients as of 4/2006 receive treatment on Arm III only
Patients are followed monthly for one year, every 3 months for 1 year, every 6 months for 1.5 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 250-400 patients will be accrued for this study within 5 years.
stage III childhood lymphoblastic lymphoma stage IV childhood lymphoblastic lymphoma Number of References to an Expanded Access Study Not provided
Target Follow-Up Duration Not provided
No data available
No data is available for this block.
Label Type Description Intervention Names A0 (localized disease Stg I/II) Modified CCG BFM Experimental Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Doxorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Methotrexate, Intrathecal Methotrexate)
Drug: asparaginase Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: mercaptopurine Drug: methotrexate Drug: prednisone Drug: thioguanine Drug: vincristine sulfate A1 (Disseminated, No CNS - CCG mod BFM w/out intens Experimental Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, prednisone, Methotrexate, Intrathecal Methotrexate)
Drug: asparaginase Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: mercaptopurine Drug: methotrexate
Name Type Description Arm Group Labels Other Names asparaginase Drug A0 (localized disease Stg I/II) Modified CCG BFM A1 (Disseminated, No CNS - CCG mod BFM w/out intens A2 (Disseminated, No CNS - CCG mod BFM w/ intens
Measure Description Time Frame Event-free Survival Assessed by time to treatment failure, occurrence of second malignant neoplasm, or death from any cause. Statistical analysis will be to estimate the difference in the proportion of patients treated with each therapy who are long-term event-free survivors due either to the difference between the backbone therapy regimens (CCG BFM vs NHL/BFM-95), or due to the intensification.
5 years
Measure Description Time Frame Percentage of Patients With Overall Survival as Assessed by Time to Death Overall survival will be computed by measuring the rate of deaths during induction due primarily to treatment toxicity and cumulative incidence of toxic deaths in induction or deaths in remission overall and separately for treatment groups defined by the two design factors.
5 years
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Adequate cardiac function
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
See Disease Characteristics
Endocrine therapy:
Emergency steroid therapy (if required) must be started within 72 hours prior to protocol therapy
Radiotherapy:
Emergency radiotherapy (if required) must be started within 72 hours prior to protocol therapy
Surgery:
Other:
No other prior therapy except for emergency treatment of airway obstruction and/or superior vena cava syndrome
Accepts Healthy Volunteers No
Name Affiliation Role Minnie Abromowitch, MD Children's Hospital Medical Center, Cincinnati Study Chair
Facility Status City State ZIP Country Contacts Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham Birmingham Alabama 35294 United States
PubMed Identifier Type Citation Retractions Result Patel JL, Smith LM, Anderson J, Abromowitch M, Campana D, Jacobsen J, Lones MA, Gross TG, Cairo MS, Perkins SL. The immunophenotype of T-lymphoblastic lymphoma in children and adolescents: a Children's Oncology Group report. Br J Haematol. 2012 Nov;159(4):454-61. doi: 10.1111/bjh.12042. Epub 2012 Sep 21. Result
Available IPD Information Not provided
No data available
No data is available for this block.
ID Title Description FG000 A0 (Localized Disease Stg I/II) Modified CCG BFM Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Doxorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Methotrexate, Intrathecal Methotrexate)
Title Milestones Reasons Not Completed Overall Study Type Comment Milestone Data STARTED
Baseline Analysis Population Description Not provided
No data available
No data is available for this block.
No data available
No data is available for this block.
No data available
No data is available for this block.
Randomized
Intervention Model Description Not provided
Drug: prednisone
Drug: thioguanine
Drug: vincristine sulfate A2 (Disseminated, No CNS - CCG mod BFM w/ intens Experimental Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
Drug: asparaginase Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: mercaptopurine Drug: methotrexate Drug: prednisone Drug: thioguanine Drug: vincristine sulfate
B2 (CNS+) NHL/BFM-95 w/intens delayed radiation therapy Experimental Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
Drug: asparaginase Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: leucovorin calcium Drug: mercaptopurine Drug: methotrexate Drug: prednisone Drug: thioguanine Drug: vincristine sulfate Radiation: radiation therapy
B1 (Disseminated CNS- <Amend 7B) NHL/BFM-95 w/out intens Experimental Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
Drug: asparaginase Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: leucovorin calcium Drug: mercaptopurine Drug: methotrexate Drug: prednisone Drug: thioguanine Drug: vincristine sulfate
B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/intens Experimental Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
Drug: asparaginase Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: leucovorin calcium Drug: mercaptopurine Drug: methotrexate Drug: prednisone Drug: thioguanine Drug: vincristine sulfate
B1 (Disseminated CNS-) NHL/BFM-95 w/out intens Experimental Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
Drug: asparaginase Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: leucovorin calcium Drug: mercaptopurine Drug: methotrexate Drug: prednisone Drug: thioguanine Drug: vincristine sulfate
B1 (Disseminated CNS- <Amend 7B) NHL/BFM-95 w/out intens
B1 (Disseminated CNS-) NHL/BFM-95 w/out intens
B2 (CNS+) NHL/BFM-95 w/intens delayed radiation therapy
B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/intens E.coli L-asparaginase EC 3.5.2.2 colaspase L-asnase Elspar Kidrolase Crasnitin Leunase NSC#109229
cyclophosphamide Drug A0 (localized disease Stg I/II) Modified CCG BFM A1 (Disseminated, No CNS - CCG mod BFM w/out intens A2 (Disseminated, No CNS - CCG mod BFM w/ intens B1 (Disseminated CNS- <Amend 7B) NHL/BFM-95 w/out intens B1 (Disseminated CNS-) NHL/BFM-95 w/out intens B2 (CNS+) NHL/BFM-95 w/intens delayed radiation therapy B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/intens
cytarabine Drug A0 (localized disease Stg I/II) Modified CCG BFM A1 (Disseminated, No CNS - CCG mod BFM w/out intens A2 (Disseminated, No CNS - CCG mod BFM w/ intens B1 (Disseminated CNS- <Amend 7B) NHL/BFM-95 w/out intens B1 (Disseminated CNS-) NHL/BFM-95 w/out intens B2 (CNS+) NHL/BFM-95 w/intens delayed radiation therapy B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/intens cytosine arabinoside Ara-C Cytosar NSC #63878
daunorubicin hydrochloride Drug A0 (localized disease Stg I/II) Modified CCG BFM A1 (Disseminated, No CNS - CCG mod BFM w/out intens A2 (Disseminated, No CNS - CCG mod BFM w/ intens B1 (Disseminated CNS- <Amend 7B) NHL/BFM-95 w/out intens B1 (Disseminated CNS-) NHL/BFM-95 w/out intens B2 (CNS+) NHL/BFM-95 w/intens delayed radiation therapy B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/intens daunomycin rubidomycin Cerubidine NSC #82151
dexamethasone Drug A0 (localized disease Stg I/II) Modified CCG BFM A1 (Disseminated, No CNS - CCG mod BFM w/out intens A2 (Disseminated, No CNS - CCG mod BFM w/ intens B1 (Disseminated CNS- <Amend 7B) NHL/BFM-95 w/out intens B1 (Disseminated CNS-) NHL/BFM-95 w/out intens B2 (CNS+) NHL/BFM-95 w/intens delayed radiation therapy B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/intens Decadron Hexadrol Dexone Dexameth NSC #34521
doxorubicin hydrochloride Drug A0 (localized disease Stg I/II) Modified CCG BFM A1 (Disseminated, No CNS - CCG mod BFM w/out intens A2 (Disseminated, No CNS - CCG mod BFM w/ intens B1 (Disseminated CNS- <Amend 7B) NHL/BFM-95 w/out intens B1 (Disseminated CNS-) NHL/BFM-95 w/out intens B2 (CNS+) NHL/BFM-95 w/intens delayed radiation therapy B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/intens
leucovorin calcium Drug B1 (Disseminated CNS- <Amend 7B) NHL/BFM-95 w/out intens B1 (Disseminated CNS-) NHL/BFM-95 w/out intens B2 (CNS+) NHL/BFM-95 w/intens delayed radiation therapy B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/intens LCV Wellcovorin citrovorum factor folinic acid NSC #003590
mercaptopurine Drug A0 (localized disease Stg I/II) Modified CCG BFM A1 (Disseminated, No CNS - CCG mod BFM w/out intens A2 (Disseminated, No CNS - CCG mod BFM w/ intens B1 (Disseminated CNS- <Amend 7B) NHL/BFM-95 w/out intens B1 (Disseminated CNS-) NHL/BFM-95 w/out intens B2 (CNS+) NHL/BFM-95 w/intens delayed radiation therapy B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/intens 6-MP Purinethol 6-mercaptopurine NSC #000755
methotrexate Drug A0 (localized disease Stg I/II) Modified CCG BFM A1 (Disseminated, No CNS - CCG mod BFM w/out intens A2 (Disseminated, No CNS - CCG mod BFM w/ intens B1 (Disseminated CNS- <Amend 7B) NHL/BFM-95 w/out intens B1 (Disseminated CNS-) NHL/BFM-95 w/out intens B2 (CNS+) NHL/BFM-95 w/intens delayed radiation therapy B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/intens MTX amethopterin Trexall NSC #000740
prednisone Drug A0 (localized disease Stg I/II) Modified CCG BFM A1 (Disseminated, No CNS - CCG mod BFM w/out intens A2 (Disseminated, No CNS - CCG mod BFM w/ intens B1 (Disseminated CNS- <Amend 7B) NHL/BFM-95 w/out intens B1 (Disseminated CNS-) NHL/BFM-95 w/out intens B2 (CNS+) NHL/BFM-95 w/intens delayed radiation therapy B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/intens Deltasone Meticorten Orasone Liquid Pred Pediapred Sterapred NSC #010023
thioguanine Drug A0 (localized disease Stg I/II) Modified CCG BFM A1 (Disseminated, No CNS - CCG mod BFM w/out intens A2 (Disseminated, No CNS - CCG mod BFM w/ intens B1 (Disseminated CNS- <Amend 7B) NHL/BFM-95 w/out intens B1 (Disseminated CNS-) NHL/BFM-95 w/out intens B2 (CNS+) NHL/BFM-95 w/intens delayed radiation therapy B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/intens 6-thioguanine 2-amino-1,7-dihydro-6H-purine-6-thione WR-1141 Tabloid Lanvis NSC # 751
vincristine sulfate Drug A0 (localized disease Stg I/II) Modified CCG BFM A1 (Disseminated, No CNS - CCG mod BFM w/out intens A2 (Disseminated, No CNS - CCG mod BFM w/ intens B1 (Disseminated CNS- <Amend 7B) NHL/BFM-95 w/out intens B1 (Disseminated CNS-) NHL/BFM-95 w/out intens B2 (CNS+) NHL/BFM-95 w/intens delayed radiation therapy B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/intens
radiation therapy Radiation B2 (CNS+) NHL/BFM-95 w/intens delayed radiation therapy
Phoenix Children's Hospital
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Little Rock Arkansas 72205 United States
Southern California Permanente Medical Group Downey California 90242-2814 United States
City of Hope Comprehensive Cancer Center Duarte California 91010-3000 United States
Loma Linda University Cancer Institute at Loma Linda University Medical Center Loma Linda California 92354 United States
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital Long Beach California 90801 United States
Childrens Hospital Los Angeles Los Angeles California 90027 United States
Jonsson Comprehensive Cancer Center at UCLA Los Angeles California 90095-1781 United States
Children's Hospital Central California Madera California 93638-8762 United States
Children's Hospital of Orange County Orange California 92868 United States
Sutter Cancer Center Sacramento California 95816 United States
University of California Davis Cancer Center Sacramento California 95817 United States
Kaiser Permanente Medical Center - Oakland Sacramento California 95825 United States
Children's Hospital and Health Center - San Diego San Diego California 92123-4282 United States
UCSF Comprehensive Cancer Center San Francisco California 94115 United States
Stanford Comprehensive Cancer Center - Stanford Stanford California 94305 United States
Children's Hospital Cancer Center Denver Colorado 80218-1088 United States
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center Farmington Connecticut 06360-2875 United States
Children's National Medical Center Washington D.C. District of Columbia 20010-2970 United States
Broward General Medical Center Cancer Center Fort Lauderdale Florida 33316 United States
Lee Cancer Care of Lee Memorial Health System Fort Myers Florida 33901 United States
University of Florida Shands Cancer Center Gainesville Florida 32610-0232 United States
Memorial Cancer Institute at Memorial Regional Hospital Hollywood Florida 33021 United States
Nemours Children's Clinic Jacksonville Florida 32207 United States
University of Miami Sylvester Comprehensive Cancer Center - Miami Miami Florida 33136 United States
Miami Children's Hospital Miami Florida 33155 United States
Florida Hospital Cancer Institute at Florida Hospital Orlando Orlando Florida 32803-1273 United States
M.D. Anderson Cancer Center at Orlando Orlando Florida 32806 United States
Nemours Children's Clinic - Orlando Orlando Florida 32806 United States
Sacred Heart Cancer Center at Sacred Heart Hospital Pensacola Florida 32504 United States
All Children's Hospital St. Petersburg Florida 33701 United States
St. Joseph's Cancer Institute at St. Joseph's Hospital Tampa Florida 33607 United States
Kaplan Cancer Center at St. Mary's Medical Center West Palm Beach Florida 33407 United States
Winship Cancer Institute of Emory University Atlanta Georgia 30322 United States
MBCCOP - Medical College of Georgia Cancer Center Augusta Georgia 30912-3730 United States
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center Savannah Georgia 31403-3089 United States
St. Luke's Mountain States Tumor Institute - Boise Boise Idaho 83712-6297 United States
University of Illinois Cancer Center Chicago Illinois 60612-7243 United States
Children's Memorial Hospital - Chicago Chicago Illinois 60614 United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center Maywood Illinois 60153 United States
Indiana University Melvin and Bren Simon Cancer Center Indianapolis Indiana 46202-5289 United States
Blank Children's Hospital Des Moines Iowa 50309 United States
Holden Comprehensive Cancer Center at University of Iowa Iowa City Iowa 52242-1002 United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center Kansas City Kansas 66160-7357 United States
Markey Cancer Center at University of Kentucky Chandler Medical Center Lexington Kentucky 40536-0293 United States
Kosair Children's Hospital Louisville Kentucky 40232 United States
Tulane Cancer Center Alexandria Louisiana 71315-3198 United States
Children's Hospital of New Orleans New Orleans Louisiana 70118 United States
Ochsner Cancer Institute at Ochsner Clinic Foundation New Orleans Louisiana 70121 United States
CancerCare of Maine at Eastern Maine Medial Center Bangor Maine 04401 United States
Maine Children's Cancer Program at Barbara Bush Children's Hospital Scarborough Maine 04074-9308 United States
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital Baltimore Maryland 21215 United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland 21231-2410 United States
Floating Hospital for Children at Tufts - New England Medical Center Boston Massachusetts 02111 United States
C.S. Mott Children's Hospital at University of Michigan Medical Center Ann Arbor Michigan 48109-0238 United States
Barbara Ann Karmanos Cancer Institute Detroit Michigan 48201-1379 United States
Hurley Medical Center Flint Michigan 48503 United States
Spectrum Health Hospital - Butterworth Campus Grand Rapids Michigan 49503-2560 United States
Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods Michigan 48236 United States
CCOP - Kalamazoo Kalamazoo Michigan 49007-5341 United States
Breslin Cancer Center at Ingham Regional Medical Center Lansing Michigan 48910 United States
William Beaumont Hospital - Royal Oak Campus Royal Oak Michigan 48073 United States
Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis Minnesota 55404 United States
University of Minnesota Children's Hospital - Fairview Minneapolis Minnesota 55455 United States
Mayo Clinic Cancer Center Rochester Minnesota 55905 United States
University of Mississippi Cancer Clinic Jackson Mississippi 39216-4505 United States
Ellis Fischel Cancer Center at University of Missouri - Columbia Columbia Missouri 65203 United States
Children's Mercy Hospital Kansas City Missouri 64108 United States
Cardinal Glennon Children's Hospital St Louis Missouri 63104 United States
Siteman Cancer Center at Barnes-Jewish Hospital St Louis Missouri 63110 United States
Children's Hospital Omaha Nebraska 68114-4113 United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center Omaha Nebraska 68198-6805 United States
Sunrise Hospital and Medical Center Las Vegas Nevada 89109-2306 United States
Norris Cotton Cancer Center at Dartmouth - Hitchcock Medical Center Lebanon New Hampshire 03756-0002 United States
Hackensack University Medical Center Cancer Center Hackensack New Jersey 07601 United States
St. Barnabas Medical Center Cancer Center Livingston New Jersey 07039 United States
Overlook Hospital Morristown New Jersey 07962 United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School New Brunswick New Jersey 08903 United States
Newark Beth Israel Medical Center Newark New Jersey 07112 United States
St. Joseph's Hospital and Medical Center Paterson New Jersey 07503 United States
University of New Mexico Cancer Research and Treatment Center Albuquerque New Mexico 87131-5636 United States
Brooklyn Hospital Center Brooklyn New York 11201-5493 United States
Roswell Park Cancer Institute Buffalo New York 14263-0001 United States
Winthrop University Hospital Mineola New York 11501 United States
Schneider Children's Hospital New Hyde Park New York 11040 United States
NYU Cancer Institute at New York University Medical Center New York New York 10016 United States
Mount Sinai Medical Center New York New York 10029 United States
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center New York New York 10032 United States
James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester New York 14642 United States
Stony Brook University Cancer Center Stony Brook New York 11794-8174 United States
SUNY Upstate Medical University Hospital Syracuse New York 13210 United States
New York Medical College Valhalla New York 10595 United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill North Carolina 27599-7295 United States
Blumenthal Cancer Center at Carolinas Medical Center Charlotte North Carolina 28232-2861 United States
Presbyterian Cancer Center at Presbyterian Hospital Charlotte North Carolina 28233-3549 United States
Duke Comprehensive Cancer Center Durham North Carolina 27710 United States
Leo W. Jenkins Cancer Center at ECU Medical School Greenville North Carolina 27835-6028 United States
Wake Forest University Comprehensive Cancer Center Winston-Salem North Carolina 27157-1096 United States
CCOP - MeritCare Hospital Fargo North Dakota 58122 United States
Children's Hospital Medical Center of Akron Akron Ohio 44308-1062 United States
Cincinnati Children's Hospital Medical Center Cincinnati Ohio 45229-3039 United States
Rainbow Babies and Children's Hospital Cleveland Ohio 44106-5000 United States
Cleveland Clinic Taussig Cancer Center Cleveland Ohio 44195-5217 United States
Columbus Children's Hospital Columbus Ohio 43205-2696 United States
Children's Medical Center - Dayton Dayton Ohio 45404-1815 United States
Toledo Hospital Toledo Ohio 43606 United States
Medical University of Ohio Cancer Center Toledo Ohio 43614 United States
Tod Children's Hospital Youngstown Ohio 44501 United States
Oklahoma University Cancer Institute Oklahoma City Oklahoma 73104 United States
Legacy Emanuel Hospital and Health Center & Children's Hospital Portland Oregon 97227 United States
Oregon Health & Science University Cancer Institute Portland Oregon 97239-3098 United States
Geisinger Medical Center Danville Pennsylvania 17822-0001 United States
Penn State Cancer Institute at Milton S. Hershey Medical Center Hershey Pennsylvania 17033-0850 United States
Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104-9786 United States
Children's Hospital of Pittsburgh Pittsburgh Pennsylvania 15213 United States
Rhode Island Hospital Comprehensive Cancer Center Providence Rhode Island 02903 United States
Hollings Cancer Center at Medical University of South Carolina Charleston South Carolina 29425 United States
Greenville Hospital System Cancer Center Greenville South Carolina 29605 United States
Sanford Cancer Center at Sanford USD Medical Center Sioux Falls South Dakota 57117-5039 United States
T.C. Thompson Children's Hospital Chattanooga Tennessee 37403 United States
East Tennessee Children's Hospital Knoxville Tennessee 37901 United States
St. Jude Children's Research Hospital Memphis Tennessee 38105 United States
Vanderbilt-Ingram Cancer Center Nashville Tennessee 37232-6838 United States
Texas Tech University Health Sciences Center School of Medicine - Amarillo Amarillo Texas 79106 United States
Children's Hospital of Austin Austin Texas 78701 United States
Driscoll Children's Hospital Corpus Christi Texas 78411 United States
Medical City Dallas Hospital Dallas Texas 75230 United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas Dallas Texas 75390 United States
Cook Children's Medical Center - Fort Worth Fort Worth Texas 76104-9958 United States
Baylor University Medical Center - Houston Houston Texas 77030-2399 United States
M. D. Anderson Cancer Center at University of Texas Houston Texas 77030-4009 United States
Covenant Children's Hospital Lubbock Texas 79410 United States
University of Texas Health Science Center at San Antonio San Antonio Texas 78207 United States
Methodist Children's Hospital of South Texas San Antonio Texas 78229-3993 United States
CCOP - Scott and White Hospital Temple Texas 76508 United States
Primary Children's Medical Center Salt Lake City Utah 84113-1100 United States
Fletcher Allen Health Care - University Health Center Campus Burlington Vermont 05405 United States
University of Virginia Cancer Center Charlottesville Virginia 22908 United States
INOVA Fairfax Hospital Fairfax Virginia 22031 United States
Children's Hospital of The King's Daughters Norfolk Virginia 23507-1971 United States
Virginia Commonwealth University Massey Cancer Center Richmond Virginia 23298-0037 United States
Carilion Cancer Center of Western Virginia Roanoke Virginia 24029 United States
Children's Hospital and Regional Medical Center - Seattle Seattle Washington 98105 United States
Providence Cancer Center at Sacred Heart Medical Center Spokane Washington 99220-2555 United States
Mary Bridge Children's Hospital and Health Center - Tacoma Tacoma Washington 98405 United States
Madigan Army Medical Center - Tacoma Tacoma Washington 98431 United States
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital Huntington West Virginia 25701 United States
Mary Babb Randolph Cancer Center at West Virginia University Hospitals Morgantown West Virginia 26506 United States
St. Vincent Hospital Regional Cancer Center Green Bay Wisconsin 54307-3508 United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center Madison Wisconsin 53792-6164 United States
Marshfield Clinic - Marshfield Center Marshfield Wisconsin 54449 United States
Prince of Wales Private Hospital Randwick New South Wales 2031 Australia
Royal Children's Hospital Herston, Brisbane Queensland 4029 Australia
Women's and Children's Hospital North Adelaide South Australia 5006 Australia
Royal Children's Hospital Parkville Victoria 3052 Australia
Princess Margaret Hospital for Children Perth Western Australia 6001 Australia
Alberta Children's Hospital Calgary Alberta T3B 6A8 Canada
Children's & Women's Hospital of British Columbia Vancouver British Columbia V6H 3V4 Canada
CancerCare Manitoba Winnipeg Manitoba R3E 0V9 Canada
Janeway Children's Health and Rehabilitation Centre St. John's Newfoundland and Labrador A1B 3V6 Canada
IWK Health Centre Halifax Nova Scotia B3K 6R8 Canada
McMaster Children's Hospital at Hamilton Health Sciences Hamilton Ontario L8N 3Z5 Canada
Cancer Centre of Southeastern Ontario at Kingston General Hospital Kingston Ontario K7L 3N6 Canada
Children's Hospital of Western Ontario London Ontario N6A 4G5 Canada
Children's Hospital of Eastern Ontario Ottawa Ontario K1H 8L1 Canada
Hospital for Sick Children Toronto Ontario M5G 1X8 Canada
Montreal Children's Hospital at McGill University Health Center Montreal Quebec H3H 1P3 Canada
Hopital Sainte Justine Montreal Quebec H3T 1C5 Canada
Allan Blair Cancer Centre at Pasqua Hospital Regina Saskatchewan S4T 7T1 Canada
Saskatoon Cancer Centre at the University of Saskatchewan Saskatoon Saskatchewan S7N 4H4 Canada
Centre Hospitalier Universitaire de Quebec Québec G1V 4G2 Canada
San Jorge Children's Hospital Santurce 00912 Puerto Rico
Swiss Pediatric Oncology Group Bern Bern 3010 Switzerland
Swiss Pediatric Oncology Group Geneva Geneva 1205 Switzerland
Swiss Pediatric Oncology Group Lausanne Lausanne 1011 Switzerland
Termuhlen AM, Smith LM, Perkins SL, Lones M, Finlay JL, Weinstein H, Gross TG, Abromowitch M. Outcome of newly diagnosed children and adolescents with localized lymphoblastic lymphoma treated on Children's Oncology Group trial A5971: a report from the Children's Oncology Group. Pediatr Blood Cancer. 2012 Dec 15;59(7):1229-33. doi: 10.1002/pbc.24149. Epub 2012 Apr 5.
Result Coustan-Smith E, Sandlund JT, Perkins SL, Chen H, Chang M, Abromowitch M, Campana D. Minimal disseminated disease in childhood T-cell lymphoblastic lymphoma: a report from the children's oncology group. J Clin Oncol. 2009 Jul 20;27(21):3533-9. doi: 10.1200/JCO.2008.21.1318. Epub 2009 Jun 22.
Result Abromowitch M, Termuhlen A, Chang M, et al.: High-dose methotrexate and early intensification of therapy do not improve 3 year EFS in children and adolescents with disseminated lymphoblastic lymphoma: results of the randomized arms of COG A5971. [Abstract] Blood 112 (11): A-3610, 2008.
Result Smock KJ, Nelson M, Tripp SR, Sanger WG, Abromowitch M, Cairo MS, Perkins SL; Children's Oncology Group. Characterization of childhood precursor T-lymphoblastic lymphoma by immunophenotyping and fluorescent in situ hybridization: a report from the Children's Oncology Group. Pediatr Blood Cancer. 2008 Oct;51(4):489-94. doi: 10.1002/pbc.21666.
Result Coustan-Smith E, Abromowitz M, Sandlund JT, et al.: A novel approach for minimal residual disease detection in childhood T-cell lymphoblastic lymphoma (T-LL): a Children's Oncology Group report. [Abstract] Blood 110 (11): A-3564, 2007.
FG001 A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, prednisone, Methotrexate, Intrathecal Methotrexate)
FG002 A2 (Disseminated, No CNS - CCG Mod BFM w/ Intens Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
FG003 B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
FG004 B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/Intens Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
FG005 B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
FG006 B1 (NHL/BFM-95 w/Out Intens) Additional Enrollment Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
FG000 60 subjects
FG001 66 subjects
FG002 65 subjects
FG003 13 subjects
FG004 67 subjects
FG005 65 subjects
FG006 57 subjects COMPLETED FG000 51 subjects FG001 51 subjects FG002 46 subjects FG003 6 subjects FG004 51 subjects FG005 51 subjects FG006 45 subjects
NOT COMPLETED FG000 9 subjects FG001 15 subjects FG002 19 subjects FG003 7 subjects FG004 16 subjects FG005 14 subjects FG006 12 subjects
Type Comment Reasons Adverse Event FG000 0 subjects FG001 1 subjects FG002 0 subjects FG003 0 subjects FG004 1 subjects FG005 0 subjects FG006 0 subjects Death FG000 0 subjects FG001 1 subjects FG002 2 subjects FG003 0 subjects FG004 Lack of Efficacy FG000 1 subjects FG001 6 subjects FG002 5 subjects FG003 3 subjects FG004 Lost to Follow-up FG000 0 subjects FG001 0 subjects FG002 1 subjects FG003 0 subjects FG004 Physician Decision FG000 1 subjects FG001 0 subjects FG002 3 subjects FG003 2 subjects FG004 Protocol Violation FG000 0 subjects FG001 5 subjects FG002 2 subjects FG003 1 subjects FG004 Withdrawal by Subject FG000 3 subjects FG001 0 subjects FG002 1 subjects FG003 0 subjects FG004 Other FG000 0 subjects FG001 0 subjects FG002 1 subjects FG003 0 subjects FG004 ineligible FG000 4 subjects FG001 2 subjects FG002 4 subjects FG003 1 subjects FG004
Type of Units Analyzed
ID Title Description BG000 A0 (Localized Disease Stg I/II) Modified CCG BFM Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Doxorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Methotrexate, Intrathecal Methotrexate)
BG001 A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, prednisone, Methotrexate, Intrathecal Methotrexate)
BG002 A2 (Disseminated, No CNS - CCG Mod BFM w/Intens Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
BG003 B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
BG004 B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/Intens Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
BG005 B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
BG006 B1 (NHL/BFM-95 w/Out Intens) Additional Enrollment Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
BG007 Total Total of all reporting groups
Units Counts Participants BG000 60 BG001 66 BG002 65 BG003 13 BG004 67 BG005 65 BG006 57 BG007 393
Title Description Population Description Parameter Type Dispersion Type Unit of Measure Calculate Percentage Denominator Units Selected Denominators Classes Age, Categorical Count of Participants Participants Title Denominators Categories Title Measurements <=18 years BG000 57 BG001 62 BG002 63 BG003
Age, Continuous Mean Standard Deviation years Title Denominators Categories Title Measurements BG000 8.7 ± 4.9 BG001 10.5 ± 5.2 BG002
Sex: Female, Male Count of Participants Participants Title Denominators Categories
Ethnicity (NIH/OMB) Count of Participants Participants Title Denominators Categories Title Measurements Hispanic or Latino
Race (NIH/OMB) Count of Participants Participants Title Denominators Categories Title Measurements American Indian or Alaska Native
Region of Enrollment Number participants Title Denominators Categories United States
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 Event-free Survival Assessed by time to treatment failure, occurrence of second malignant neoplasm, or death from any cause. Statistical analysis will be to estimate the difference in the proportion of patients treated with each therapy who are long-term event-free survivors due either to the difference between the backbone therapy regimens (CCG BFM vs NHL/BFM-95), or due to the intensification.
There were 19 total ineligible patients, 4 for A0, 2 for A1, 4 for A2, 1 for B2 (CNS+), 1 for B2 (Disseminated), 2 for B1 (CNS-), and 5 for B1 (NHL additional enrollment) not included in outcome measure analysis.
Posted Number 95% Confidence Interval percentage of particpants 5 years ID Title Description OG000 A0 (Localized Disease Stg I/II) Modified CCG BFM Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Doxorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Methotrexate, Intrathecal Methotrexate)
OG001 A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, prednisone, Methotrexate, Intrathecal Methotrexate)
OG002 A2 (Disseminated, No CNS - CCG Mod BFM w/ Intens Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
OG003 B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
OG004 B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/Intens Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
OG005 B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
OG006 B1 (NHL/BFM-95 w/Out Intens) Additional Enrollment Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
Units Counts Participants OG000 56 OG001 64 OG002 61 OG003
Title Denominators Categories Title Measurements OG000 88 (76 to 95) OG001 82 (70 to 90) OG002 80 (67 to 89) OG003
Group IDs Group Description Statistical Method Statistical Comment P-Value P-Value Comment Parameter Type Parameter Value Dispersion Type Dispersion Value Confidence Interval Sides Confidence Interval % CI Lower Limit CI Upper Limit CI Lower Limit Comment CI Upper Limit Comment Estimate Comment Tested Non-Inferiority Non-Inferiority Type Non-Inferiority Comment Other Analysis Description OG001 OG002 OG003 OG005 OG006 A Cox model was used to assess evidence of a difference in event-free survival comparing regimens A1+A2 ("A: CCG BFM") to regimens B1+B2 ("B: NHL/BFM-95") while adjusting for the other intervention through stratification.
Regression, Cox .97 2-Sided Superiority or Other
Secondary Percentage of Patients With Overall Survival as Assessed by Time to Death Overall survival will be computed by measuring the rate of deaths during induction due primarily to treatment toxicity and cumulative incidence of toxic deaths in induction or deaths in remission overall and separately for treatment groups defined by the two design factors.
There were 19 total ineligible patients, 4 for A0, 2 for A1, 4 for A2, 1 for B2 (CNS+), 1 for B2 (Disseminated), 2 for B1 (CNS-), and 5 for B1 (NHL additional enrollment) not included in outcome measure analysis.
Posted Number 95% Confidence Interval percentage of participants 5 years ID Title Description OG000 A0 (Localized Disease Stg I/II) Modified CCG BFM Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Doxorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Methotrexate, Intrathecal Methotrexate)
OG001 A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, prednisone, Methotrexate, Intrathecal Methotrexate)
There were 19 total ineligible patients, 4 for A0, 2 for A1, 4 for A2, 1 for B2 (CNS+), 1 for B2 (Disseminated), 2 for B1 (CNS-), and 5 for B1 (NHL additional enrollment). All ineligible patients excluded from adverse event reporting.
All-Cause Mortality Comment 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 A0 (Localized Disease Stg I/II) Modified CCG BFM Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Doxorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Methotrexate, Intrathecal Methotrexate)
8 56 56 56 EG001 A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, prednisone, Methotrexate, Intrathecal Methotrexate)
8 64 64 64 EG002 A2 (Disseminated, No CNS - CCG Mod BFM w/Intens Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate).
13 61 60 61 EG003 B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
0 12 10 12 EG004 B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/Intens Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
12 66 66 66 EG005 B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
9 63 62 63 EG006 B1 (NHL/BFM-95 w/Out Intens) Additional Enrollment Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
1 52 52 52
Term Organ System Source Vocabulary Assessment Type Notes Statistical Information Bilirubin Investigations EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 0 events 0 affected 12 at risk EG004 0 events 0 affected 66 at risk EG005 2 events 1 affected 63 at risk EG006 1 events 1 affected 52 at risk CNS cerebrovascular ischemia Nervous system disorders EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 1 events 1 affected 61 at risk EG003 Cardiovascular/Arrhythmia Cardiac disorders EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Cardiovascular/General-Other Cardiac disorders EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Catheter-related infection Infections and infestations EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 1 events 1 affected 61 at risk EG003 Cortical blindness, Anxiety, agitation Nervous system disorders EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Esophagitis Gastrointestinal disorders EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 1 events 1 affected 61 at risk EG003 Febrile neutropenia Blood and lymphatic system disorders EG000 1 events 1 affected 56 at risk EG001 1 events 1 affected 64 at risk EG002 1 events 1 affected 61 at risk EG003 Fever, Increase BP, Back pain General disorders EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 1 events 1 affected 61 at risk EG003 GGT Investigations EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Headache, Vomiting, Nausea, Pancytopenia, Fever General disorders EG000 0 events 0 affected 56 at risk EG001 1 events 1 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Hemoglobin (Hgb) Blood and lymphatic system disorders EG000 2 events 2 affected 56 at risk EG001 2 events 2 affected 64 at risk EG002 3 events 2 affected 61 at risk EG003 Hepatotoxicity Hepatobiliary disorders EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 infection Infections and infestations EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 1 events 1 affected 61 at risk EG003 Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia Infections and infestations EG000 2 events 2 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 3 events 3 affected 61 at risk EG003 Infection without neutropenia Infections and infestations EG000 1 events 1 affected 56 at risk EG001 1 events 1 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Infection/Febrile Neutropenia Infections and infestations EG000 1 events 1 affected 56 at risk EG001 1 events 1 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Infection/Febrile Neutropenia (sepsis) Infections and infestations EG000 0 events 0 affected 56 at risk EG001 1 events 1 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Leukocytes (total WBC) Blood and lymphatic system disorders EG000 8 events 8 affected 56 at risk EG001 5 events 5 affected 64 at risk EG002 7 events 7 affected 61 at risk EG003 Lt Hemiplegia Nervous system disorders EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 1 events 1 affected 61 at risk EG003 N/V, Diplopia Eye disorders EG000 0 events 0 affected 56 at risk EG001 1 events 1 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Neutropenia Blood and lymphatic system disorders EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Pancreatitis Gastrointestinal disorders EG000 1 events 1 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 1 events 1 affected 61 at risk EG003 Partial thromboplastin time Investigations EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Platelets Investigations EG000 4 events 4 affected 56 at risk EG001 3 events 3 affected 64 at risk EG002 1 events 1 affected 61 at risk EG003 SGOT (AST) Investigations EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 1 events 1 affected 61 at risk EG003 SGPT (ALT) Investigations EG000 2 events 1 affected 56 at risk EG001 1 events 1 affected 64 at risk EG002 2 events 2 affected 61 at risk EG003 Seizure Nervous system disorders EG000 0 events 0 affected 56 at risk EG001 2 events 2 affected 64 at risk EG002 1 events 1 affected 61 at risk EG003 Typhlitis Gastrointestinal disorders EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Clot Vascular disorders EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 difficulty with speech, Left sided numbness Nervous system disorders EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 1 events 1 affected 61 at risk EG003
Term Organ System Source Vocabulary Assessment Type Notes Statistical Information Allergic reaction/hypersensitivity Immune system disorders EG000 2 events 1 affected 56 at risk EG001 5 events 4 affected 64 at risk EG002 1 events 1 affected 61 at risk EG003 1 events 1 affected 12 at risk EG004 4 events 3 affected 66 at risk EG005 3 events 3 affected 63 at risk EG006 1 events 1 affected 52 at risk Autoimmune reaction Immune system disorders EG000 0 events 0 affected 56 at risk EG001 1 events 1 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Allergy/Immunology Immune system disorders EG000 0 events 0 affected 56 at risk EG001 1 events 1 affected 64 at risk EG002 2 events 2 affected 61 at risk EG003 Inner ear/hearing Ear and labyrinth disorders EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Middle ear/hearing Ear and labyrinth disorders EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 1 events 1 affected 61 at risk EG003 Auditory/Hearing Ear and labyrinth disorders EG000 0 events 0 affected 56 at risk EG001 1 events 1 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Hemoglobin (Hgb) Blood and lymphatic system disorders EG000 509 events 56 affected 56 at risk EG001 533 events 64 affected 64 at risk EG002 520 events 60 affected 61 at risk EG003 Hemolysis Blood and lymphatic system disorders EG000 0 events 0 affected 56 at risk EG001 1 events 1 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Leukocytes (total WBC) Investigations EG000 532 events 56 affected 56 at risk EG001 552 events 64 affected 64 at risk EG002 536 events 60 affected 61 at risk EG003 Lymphopenia Investigations EG000 40 events 12 affected 56 at risk EG001 52 events 13 affected 64 at risk EG002 40 events 10 affected 61 at risk EG003 Neutrophils/granulocytes (ANC/AGC) Investigations EG000 86 events 28 affected 56 at risk EG001 139 events 45 affected 64 at risk EG002 116 events 40 affected 61 at risk EG003 Platelets Investigations EG000 469 events 56 affected 56 at risk EG001 523 events 64 affected 64 at risk EG002 499 events 60 affected 61 at risk EG003 Transfusion: Platelets Blood and lymphatic system disorders EG000 28 events 19 affected 56 at risk EG001 24 events 14 affected 64 at risk EG002 21 events 18 affected 61 at risk EG003 Transfusion: pRBCs Blood and lymphatic system disorders EG000 40 events 24 affected 56 at risk EG001 54 events 29 affected 64 at risk EG002 42 events 25 affected 61 at risk EG003 Blood/Bone Marrow Blood and lymphatic system disorders EG000 1 events 1 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 3 events 3 affected 61 at risk EG003 Palpitations Cardiac disorders EG000 0 events 0 affected 56 at risk EG001 3 events 1 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Sinus bradycardia Cardiac disorders EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Sinus tachycardia Cardiac disorders EG000 1 events 1 affected 56 at risk EG001 1 events 1 affected 64 at risk EG002 3 events 2 affected 61 at risk EG003 Vasovagal episode Nervous system disorders EG000 0 events 0 affected 56 at risk EG001 1 events 1 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Cardiovascular/Arrhythmia Cardiac disorders EG000 406 events 48 affected 56 at risk EG001 469 events 59 affected 64 at risk EG002 458 events 56 affected 61 at risk EG003 Cardiac left ventricular function Cardiac disorders EG000 428 events 52 affected 56 at risk EG001 482 events 61 affected 64 at risk EG002 462 events 56 affected 61 at risk EG003 Edema Cardiac disorders EG000 0 events 0 affected 56 at risk EG001 2 events 2 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Hypertension Vascular disorders EG000 2 events 1 affected 56 at risk EG001 4 events 4 affected 64 at risk EG002 7 events 6 affected 61 at risk EG003 Hypotension Vascular disorders EG000 1 events 1 affected 56 at risk EG001 2 events 2 affected 64 at risk EG002 5 events 4 affected 61 at risk EG003 Pericardial effusion/pericarditis Cardiac disorders EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 2 events 2 affected 61 at risk EG003 Thrombosis/embolism Vascular disorders EG000 2 events 2 affected 56 at risk EG001 7 events 7 affected 64 at risk EG002 4 events 4 affected 61 at risk EG003 Cardiovascular/General Cardiac disorders EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 1 events 1 affected 61 at risk EG003 DIC (disseminated intravascular coagulation) Blood and lymphatic system disorders EG000 0 events 0 affected 56 at risk EG001 1 events 1 affected 64 at risk EG002 2 events 2 affected 61 at risk EG003 Fibrinogen Investigations EG000 4 events 3 affected 56 at risk EG001 3 events 3 affected 64 at risk EG002 4 events 4 affected 61 at risk EG003 Partial thromboplastin time (PTT) Investigations EG000 0 events 0 affected 56 at risk EG001 2 events 2 affected 64 at risk EG002 3 events 3 affected 61 at risk EG003 Prothrombin time (PT) Investigations EG000 1 events 1 affected 56 at risk EG001 2 events 1 affected 64 at risk EG002 1 events 1 affected 61 at risk EG003 Coagulation Investigations EG000 1 events 1 affected 56 at risk EG001 2 events 2 affected 64 at risk EG002 1 events 1 affected 61 at risk EG003 Fatigue (lethargy, malaise, asthenia) General disorders EG000 6 events 3 affected 56 at risk EG001 7 events 3 affected 64 at risk EG002 5 events 4 affected 61 at risk EG003 Fever General disorders EG000 7 events 5 affected 56 at risk EG001 3 events 2 affected 64 at risk EG002 7 events 5 affected 61 at risk EG003 Rigors, chills General disorders EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Weight gain General disorders EG000 2 events 1 affected 56 at risk EG001 14 events 5 affected 64 at risk EG002 2 events 1 affected 61 at risk EG003 Weight loss General disorders EG000 0 events 0 affected 56 at risk EG001 4 events 2 affected 64 at risk EG002 4 events 4 affected 61 at risk EG003 Constitutional Symptoms General disorders EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 2 events 1 affected 61 at risk EG003 Alopecia Skin and subcutaneous tissue disorders EG000 0 events 0 affected 56 at risk EG001 8 events 3 affected 64 at risk EG002 1 events 1 affected 61 at risk EG003 Dry skin Skin and subcutaneous tissue disorders EG000 0 events 0 affected 56 at risk EG001 1 events 1 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Erythema multiforme Skin and subcutaneous tissue disorders EG000 0 events 0 affected 56 at risk EG001 1 events 1 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Flushing Vascular disorders EG000 1 events 1 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Hand-foot skin reaction Skin and subcutaneous tissue disorders EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Injection site reaction General disorders EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Pruritus Skin and subcutaneous tissue disorders EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 2 events 2 affected 61 at risk EG003 Rash/desquamation Skin and subcutaneous tissue disorders EG000 2 events 2 affected 56 at risk EG001 6 events 3 affected 64 at risk EG002 6 events 4 affected 61 at risk EG003 Urticaria Skin and subcutaneous tissue disorders EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Wound-infectious Infections and infestations EG000 0 events 0 affected 56 at risk EG001 2 events 1 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Wound-non infectious Injury, poisoning and procedural complications EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 1 events 1 affected 61 at risk EG003 Dermatology/Skin Skin and subcutaneous tissue disorders EG000 1 events 1 affected 56 at risk EG001 2 events 2 affected 64 at risk EG002 10 events 7 affected 61 at risk EG003 Cushingoid appearance Endocrine disorders EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 3 events 3 affected 61 at risk EG003 SIADH (syndrome of inappropriate antidiuretic hormone) Investigations EG000 0 events 0 affected 56 at risk EG001 1 events 1 affected 64 at risk EG002 1 events 1 affected 61 at risk EG003 Endocrine Endocrine disorders EG000 0 events 0 affected 56 at risk EG001 2 events 2 affected 64 at risk EG002 1 events 1 affected 61 at risk EG003 Anorexia Metabolism and nutrition disorders EG000 2 events 2 affected 56 at risk EG001 7 events 7 affected 64 at risk EG002 9 events 5 affected 61 at risk EG003 Colitis Gastrointestinal disorders EG000 0 events 0 affected 56 at risk EG001 2 events 2 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Constipation Gastrointestinal disorders EG000 2 events 2 affected 56 at risk EG001 13 events 7 affected 64 at risk EG002 7 events 5 affected 61 at risk EG003 Dehydration Metabolism and nutrition disorders EG000 1 events 1 affected 56 at risk EG001 7 events 7 affected 64 at risk EG002 4 events 4 affected 61 at risk EG003 Diarrhea (without colostomy) Gastrointestinal disorders EG000 7 events 7 affected 56 at risk EG001 13 events 7 affected 64 at risk EG002 9 events 7 affected 61 at risk EG003 Dyspepsia/heartburn Gastrointestinal disorders EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Dysphagia, esophagitis, odynophagia (painful swallowing) Gastrointestinal disorders EG000 0 events 0 affected 56 at risk EG001 1 events 1 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Fistula-intestinal Gastrointestinal disorders EG000 0 events 0 affected 56 at risk EG001 1 events 1 affected 64 at risk EG002 1 events 1 affected 61 at risk EG003 Fistula-rectal/anal Gastrointestinal disorders EG000 0 events 0 affected 56 at risk EG001 1 events 1 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Gastric ulcer Gastrointestinal disorders EG000 0 events 0 affected 56 at risk EG001 1 events 1 affected 64 at risk EG002 1 events 1 affected 61 at risk EG003 Gastritis Gastrointestinal disorders EG000 0 events 0 affected 56 at risk EG001 3 events 3 affected 64 at risk EG002 1 events 1 affected 61 at risk EG003 Ileus Gastrointestinal disorders EG000 2 events 1 affected 56 at risk EG001 1 events 1 affected 64 at risk EG002 1 events 1 affected 61 at risk EG003 Mouth dryness Gastrointestinal disorders EG000 0 events 0 affected 56 at risk EG001 1 events 1 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Nausea Gastrointestinal disorders EG000 8 events 6 affected 56 at risk EG001 16 events 9 affected 64 at risk EG002 14 events 5 affected 61 at risk EG003 Pancreatitis Gastrointestinal disorders EG000 431 events 52 affected 56 at risk EG001 481 events 61 affected 64 at risk EG002 458 events 56 affected 61 at risk EG003 Proctitis Gastrointestinal disorders EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 1 events 1 affected 61 at risk EG003 Stomatitis/pharyngitis (oral/pharyngeal mucositis) Gastrointestinal disorders EG000 7 events 4 affected 56 at risk EG001 13 events 9 affected 64 at risk EG002 11 events 7 affected 61 at risk EG003 Typhlitis (inflammation of cecum) Gastrointestinal disorders EG000 0 events 0 affected 56 at risk EG001 2 events 2 affected 64 at risk EG002 3 events 2 affected 61 at risk EG003 Vomiting Gastrointestinal disorders EG000 12 events 8 affected 56 at risk EG001 15 events 7 affected 64 at risk EG002 11 events 8 affected 61 at risk EG003 Gastrointestinal Gastrointestinal disorders EG000 0 events 0 affected 56 at risk EG001 4 events 3 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia Vascular disorders EG000 0 events 0 affected 56 at risk EG001 3 events 3 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 CNS hemorrhage/bleeding Nervous system disorders EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 1 events 1 affected 61 at risk EG003 Epistaxis Respiratory, thoracic and mediastinal disorders EG000 3 events 2 affected 56 at risk EG001 1 events 1 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Hematemesis Gastrointestinal disorders EG000 0 events 0 affected 56 at risk EG001 1 events 1 affected 64 at risk EG002 1 events 1 affected 61 at risk EG003 Hematuria (in the absence of vaginal bleeding) Renal and urinary disorders EG000 2 events 2 affected 56 at risk EG001 1 events 1 affected 64 at risk EG002 1 events 1 affected 61 at risk EG003 Melena/GI bleeding Gastrointestinal disorders EG000 1 events 1 affected 56 at risk EG001 1 events 1 affected 64 at risk EG002 1 events 1 affected 61 at risk EG003 Petechiae/purpura (hemorrhage/bleeding into skin or mucosa) Skin and subcutaneous tissue disorders EG000 0 events 0 affected 56 at risk EG001 1 events 1 affected 64 at risk EG002 1 events 1 affected 61 at risk EG003 Rectal bleeding/hematochezia Gastrointestinal disorders EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 1 events 1 affected 61 at risk EG003 Vaginal bleeding Reproductive system and breast disorders EG000 0 events 0 affected 56 at risk EG001 1 events 1 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Alkaline phosphatase Investigations EG000 11 events 4 affected 56 at risk EG001 2 events 2 affected 64 at risk EG002 4 events 3 affected 61 at risk EG003 Bilirubin Investigations EG000 444 events 53 affected 56 at risk EG001 492 events 61 affected 64 at risk EG002 483 events 57 affected 61 at risk EG003 GGT Investigations EG000 3 events 1 affected 56 at risk EG001 9 events 3 affected 64 at risk EG002 3 events 3 affected 61 at risk EG003 Hepatic enlargement Hepatobiliary disorders EG000 1 events 1 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Hypoalbuminemia Metabolism and nutrition disorders EG000 12 events 8 affected 56 at risk EG001 9 events 5 affected 64 at risk EG002 9 events 7 affected 61 at risk EG003 SGOT (AST) Investigations EG000 469 events 54 affected 56 at risk EG001 502 events 62 affected 64 at risk EG002 492 events 59 affected 61 at risk EG003 SGPT (ALT) Investigations EG000 487 events 54 affected 56 at risk EG001 516 events 63 affected 64 at risk EG002 505 events 59 affected 61 at risk EG003 Hepatic Hepatobiliary disorders EG000 0 events 0 affected 56 at risk EG001 5 events 1 affected 64 at risk EG002 1 events 1 affected 61 at risk EG003 Catheter-related infection Infections and infestations EG000 430 events 51 affected 56 at risk EG001 483 events 63 affected 64 at risk EG002 460 events 58 affected 61 at risk EG003 Febrile neutropenia Blood and lymphatic system disorders EG000 451 events 56 affected 56 at risk EG001 490 events 62 affected 64 at risk EG002 472 events 59 affected 61 at risk EG003 Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia Infections and infestations EG000 441 events 54 affected 56 at risk EG001 488 events 63 affected 64 at risk EG002 469 events 59 affected 61 at risk EG003 Infection with unknown ANC Infections and infestations EG000 0 events 0 affected 56 at risk EG001 1 events 1 affected 64 at risk EG002 1 events 1 affected 61 at risk EG003 Infection without neutropenia Infections and infestations EG000 438 events 53 affected 56 at risk EG001 485 events 63 affected 64 at risk EG002 461 events 57 affected 61 at risk EG003 Infection/Febrile Neutropenia Infections and infestations EG000 410 events 50 affected 56 at risk EG001 467 events 58 affected 64 at risk EG002 460 events 58 affected 61 at risk EG003 Lymphatics Blood and lymphatic system disorders EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Acidosis (metabolic or respiratory) Metabolism and nutrition disorders EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 1 events 1 affected 61 at risk EG003 Amylase Investigations EG000 0 events 0 affected 56 at risk EG001 3 events 3 affected 64 at risk EG002 3 events 3 affected 61 at risk EG003 Bicarbonate Metabolism and nutrition disorders EG000 4 events 3 affected 56 at risk EG001 2 events 2 affected 64 at risk EG002 1 events 1 affected 61 at risk EG003 Hypercalcemia Metabolism and nutrition disorders EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 4 events 4 affected 61 at risk EG003 Hypercholesterolemia Investigations EG000 1 events 1 affected 56 at risk EG001 1 events 1 affected 64 at risk EG002 1 events 1 affected 61 at risk EG003 Hyperglycemia Metabolism and nutrition disorders EG000 15 events 7 affected 56 at risk EG001 27 events 13 affected 64 at risk EG002 25 events 13 affected 61 at risk EG003 Hyperkalemia Metabolism and nutrition disorders EG000 2 events 2 affected 56 at risk EG001 7 events 4 affected 64 at risk EG002 2 events 2 affected 61 at risk EG003 Hypermagnesemia Metabolism and nutrition disorders EG000 2 events 1 affected 56 at risk EG001 3 events 2 affected 64 at risk EG002 4 events 4 affected 61 at risk EG003 Hypernatremia Metabolism and nutrition disorders EG000 1 events 1 affected 56 at risk EG001 2 events 2 affected 64 at risk EG002 4 events 3 affected 61 at risk EG003 Hypertriglyceridemia Metabolism and nutrition disorders EG000 0 events 0 affected 56 at risk EG001 2 events 2 affected 64 at risk EG002 2 events 1 affected 61 at risk EG003 Hyperuricemia Metabolism and nutrition disorders EG000 1 events 1 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 5 events 2 affected 61 at risk EG003 Hypocalcemia Metabolism and nutrition disorders EG000 11 events 7 affected 56 at risk EG001 9 events 7 affected 64 at risk EG002 17 events 10 affected 61 at risk EG003 Hypoglycemia Metabolism and nutrition disorders EG000 1 events 1 affected 56 at risk EG001 3 events 2 affected 64 at risk EG002 2 events 2 affected 61 at risk EG003 Hypokalemia Metabolism and nutrition disorders EG000 19 events 10 affected 56 at risk EG001 15 events 8 affected 64 at risk EG002 20 events 11 affected 61 at risk EG003 Hypomagnesemia Metabolism and nutrition disorders EG000 2 events 2 affected 56 at risk EG001 6 events 5 affected 64 at risk EG002 4 events 2 affected 61 at risk EG003 Hyponatremia Metabolism and nutrition disorders EG000 10 events 6 affected 56 at risk EG001 6 events 5 affected 64 at risk EG002 10 events 7 affected 61 at risk EG003 Hypophosphatemia Metabolism and nutrition disorders EG000 8 events 5 affected 56 at risk EG001 6 events 5 affected 64 at risk EG002 6 events 4 affected 61 at risk EG003 Lipase Investigations EG000 0 events 0 affected 56 at risk EG001 1 events 1 affected 64 at risk EG002 2 events 2 affected 61 at risk EG003 Metabolic/Laboratory Investigations EG000 7 events 3 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 3 events 3 affected 61 at risk EG003 Arthritis Musculoskeletal and connective tissue disorders EG000 0 events 0 affected 56 at risk EG001 2 events 2 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Muscle weakness (not due to neuropathy) Musculoskeletal and connective tissue disorders EG000 1 events 1 affected 56 at risk EG001 1 events 1 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Osteonecrosis (avascular necrosis) Musculoskeletal and connective tissue disorders EG000 430 events 52 affected 56 at risk EG001 480 events 61 affected 64 at risk EG002 460 events 57 affected 61 at risk EG003 Musculoskeletal Musculoskeletal and connective tissue disorders EG000 1 events 1 affected 56 at risk EG001 1 events 1 affected 64 at risk EG002 2 events 2 affected 61 at risk EG003 Arachnoiditis/meningismus/radiculitis Nervous system disorders EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Ataxia (incoordination) Nervous system disorders EG000 1 events 1 affected 56 at risk EG001 1 events 1 affected 64 at risk EG002 3 events 2 affected 61 at risk EG003 CNS cerebrovascular ischemia Nervous system disorders EG000 428 events 51 affected 56 at risk EG001 482 events 61 affected 64 at risk EG002 456 events 56 affected 61 at risk EG003 Confusion Psychiatric disorders EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Delusions Psychiatric disorders EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Depressed level of consciousness Nervous system disorders EG000 0 events 0 affected 56 at risk EG001 1 events 1 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Dizziness/lightheadedness Nervous system disorders EG000 0 events 0 affected 56 at risk EG001 5 events 3 affected 64 at risk EG002 2 events 2 affected 61 at risk EG003 Extrapyramidal/involuntary movement/restlessness Nervous system disorders EG000 1 events 1 affected 56 at risk EG001 1 events 1 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Hallucinations Psychiatric disorders EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Insomnia General disorders EG000 0 events 0 affected 56 at risk EG001 2 events 2 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Leukoencephalopathy associated radiological findings Nervous system disorders EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 1 events 1 affected 61 at risk EG003 Memory loss Nervous system disorders EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Mood alteration-anxiety, agitation Psychiatric disorders EG000 2 events 2 affected 56 at risk EG001 2 events 2 affected 64 at risk EG002 1 events 1 affected 61 at risk EG003 Mood alteration-depression Psychiatric disorders EG000 0 events 0 affected 56 at risk EG001 9 events 4 affected 64 at risk EG002 2 events 2 affected 61 at risk EG003 Neuropathy - cranial Nervous system disorders EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 1 events 1 affected 61 at risk EG003 Neuropathy - motor Nervous system disorders EG000 3 events 3 affected 56 at risk EG001 5 events 4 affected 64 at risk EG002 7 events 7 affected 61 at risk EG003 Neuropathy - sensory Nervous system disorders EG000 0 events 0 affected 56 at risk EG001 3 events 3 affected 64 at risk EG002 3 events 3 affected 61 at risk EG003 Personality/behavioral Psychiatric disorders EG000 0 events 0 affected 56 at risk EG001 2 events 1 affected 64 at risk EG002 2 events 1 affected 61 at risk EG003 Seizure(s) Nervous system disorders EG000 432 events 51 affected 56 at risk EG001 481 events 62 affected 64 at risk EG002 456 events 56 affected 61 at risk EG003 Speech impairment Nervous system disorders EG000 0 events 0 affected 56 at risk EG001 1 events 1 affected 64 at risk EG002 2 events 2 affected 61 at risk EG003 Syncope (fainting) Nervous system disorders EG000 0 events 0 affected 56 at risk EG001 5 events 3 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Tremor Nervous system disorders EG000 0 events 0 affected 56 at risk EG001 1 events 1 affected 64 at risk EG002 1 events 1 affected 61 at risk EG003 Vertigo Nervous system disorders EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 2 events 1 affected 61 at risk EG003 Neurology Nervous system disorders EG000 2 events 2 affected 56 at risk EG001 2 events 2 affected 64 at risk EG002 1 events 1 affected 61 at risk EG003 Conjunctivitis Eye disorders EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Tearing (watery eyes) Eye disorders EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Vision-blurred vision Eye disorders EG000 0 events 0 affected 56 at risk EG001 1 events 1 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Vision-photophobia Eye disorders EG000 0 events 0 affected 56 at risk EG001 1 events 1 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Ocular/Visual Eye disorders EG000 0 events 0 affected 56 at risk EG001 1 events 1 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Abdominal pain or cramping Gastrointestinal disorders EG000 5 events 2 affected 56 at risk EG001 10 events 6 affected 64 at risk EG002 8 events 7 affected 61 at risk EG003 Arthralgia (joint pain) General disorders EG000 2 events 2 affected 56 at risk EG001 3 events 3 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Bone pain General disorders EG000 0 events 0 affected 56 at risk EG001 3 events 3 affected 64 at risk EG002 5 events 3 affected 61 at risk EG003 Chest pain (non-cardiac and non-pleuritic) General disorders EG000 0 events 0 affected 56 at risk EG001 1 events 1 affected 64 at risk EG002 2 events 2 affected 61 at risk EG003 Earache (otalgia) Ear and labyrinth disorders EG000 0 events 0 affected 56 at risk EG001 3 events 3 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Headache General disorders EG000 6 events 3 affected 56 at risk EG001 23 events 9 affected 64 at risk EG002 10 events 9 affected 61 at risk EG003 Myalgia (muscle pain) General disorders EG000 2 events 2 affected 56 at risk EG001 8 events 5 affected 64 at risk EG002 2 events 2 affected 61 at risk EG003 Neuropathic pain General disorders EG000 2 events 1 affected 56 at risk EG001 8 events 5 affected 64 at risk EG002 6 events 5 affected 61 at risk EG003 Pelvic pain General disorders EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Pleuritic pain General disorders EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Rectal or perirectal pain Gastrointestinal disorders EG000 1 events 1 affected 56 at risk EG001 2 events 2 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Tumor pain General disorders EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Pain General disorders EG000 2 events 2 affected 56 at risk EG001 7 events 6 affected 64 at risk EG002 7 events 5 affected 61 at risk EG003 Adult respiratory distress syndrome (ARDS) Respiratory, thoracic and mediastinal disorders EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 2 events 2 affected 61 at risk EG003 Apnea Respiratory, thoracic and mediastinal disorders EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Cough Respiratory, thoracic and mediastinal disorders EG000 8 events 2 affected 56 at risk EG001 8 events 5 affected 64 at risk EG002 2 events 2 affected 61 at risk EG003 Dyspnea (shortness of breath) Respiratory, thoracic and mediastinal disorders EG000 0 events 0 affected 56 at risk EG001 3 events 3 affected 64 at risk EG002 2 events 2 affected 61 at risk EG003 Hypoxia Respiratory, thoracic and mediastinal disorders EG000 2 events 2 affected 56 at risk EG001 2 events 2 affected 64 at risk EG002 4 events 4 affected 61 at risk EG003 Pleural effusion (non-malignant) Respiratory, thoracic and mediastinal disorders EG000 0 events 0 affected 56 at risk EG001 1 events 1 affected 64 at risk EG002 8 events 6 affected 61 at risk EG003 Pneumonitis/pulmonary infiltrates Respiratory, thoracic and mediastinal disorders EG000 0 events 0 affected 56 at risk EG001 1 events 1 affected 64 at risk EG002 5 events 5 affected 61 at risk EG003 Pneumothorax Respiratory, thoracic and mediastinal disorders EG000 0 events 0 affected 56 at risk EG001 1 events 1 affected 64 at risk EG002 1 events 1 affected 61 at risk EG003 Voice changes/stridor/larynx Respiratory, thoracic and mediastinal disorders EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Pulmonary Respiratory, thoracic and mediastinal disorders EG000 1 events 1 affected 56 at risk EG001 1 events 1 affected 64 at risk EG002 1 events 1 affected 61 at risk EG003 Serum Creatinine Investigations EG000 438 events 51 affected 56 at risk EG001 482 events 62 affected 64 at risk EG002 467 events 57 affected 61 at risk EG003 Dysuria Renal and urinary disorders EG000 1 events 1 affected 56 at risk EG001 2 events 2 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Incontinence Renal and urinary disorders EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Proteinuria Renal and urinary disorders EG000 0 events 0 affected 56 at risk EG001 2 events 2 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Renal failure Renal and urinary disorders EG000 431 events 51 affected 56 at risk EG001 480 events 61 affected 64 at risk EG002 457 events 57 affected 61 at risk EG003 Urinary electrolyte wasting Metabolism and nutrition disorders EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Urinary frequency/urgency Renal and urinary disorders EG000 0 events 0 affected 56 at risk EG001 1 events 1 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Urinary retention Renal and urinary disorders EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Renal/Genitourinary Renal and urinary disorders EG000 1 events 1 affected 56 at risk EG001 2 events 2 affected 64 at risk EG002 2 events 2 affected 61 at risk EG003 Secondary malignancy - Other (Specify type, excludes metastastic tumors) Neoplasms benign, malignant and unspecified (incl cysts and polyps) EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Irregular menses Reproductive system and breast disorders EG000 0 events 0 affected 56 at risk EG001 1 events 1 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Tumor lysis syndrome Metabolism and nutrition disorders EG000 0 events 0 affected 56 at risk EG001 1 events 1 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Syndromes General disorders EG000 0 events 0 affected 56 at risk EG001 0 events 0 affected 64 at risk EG002 0 events 0 affected 61 at risk EG003 Allergic Rhinitis Respiratory, thoracic and mediastinal disorders EG000 0 events 0 affected 56 at risk EG001 9 events 2 affected 64 at risk EG002 5 events 3 affected 61 at risk EG003
Are all PI(s) employees of the sponsor? No
Results Disclosure Restriction on PI(s)? Yes
Must obtain prior Sponsor approval.
Title Organization Phone Extension Email Results Reporting Coordinator Children's Oncology Group 626-447-0064 resultsreportingcoordinator@childrensoncologygroup.org
ID Term D009370 Neoplasms by Histologic Type D009369 Neoplasms D008232 Lymphoproliferative Disorders D008206 Lymphatic Diseases D006425 Hemic and Lymphatic Diseases D007160 Immunoproliferative Disorders D007154 Immune System Diseases
ID Term D001215 Asparaginase D003520 Cyclophosphamide D003561 Cytarabine D003630 Daunorubicin D003907 Dexamethasone D002123 Calcium Dobesilate D004317 Doxorubicin D002955 Leucovorin D015122 Mercaptopurine D008727 Methotrexate D011241 Prednisone C009022 prednisolone phosphate D013866 Thioguanine D014750 Vincristine D011878 Radiotherapy
ID Term D000581 Amidohydrolases D006867 Hydrolases D004798 Enzymes D045762 Enzymes and Coenzymes D010752 Phosphoramide Mustards D009588 Nitrogen Mustard Compounds D009150 Mustard Compounds D006846 Hydrocarbons, Halogenated D006838 Hydrocarbons D009930 Organic Chemicals D063088 Phosphoramides D009943 Organophosphorus Compounds D003562 Cytidine D011741 Pyrimidine Nucleosides D011743 Pyrimidines D006573 Heterocyclic Compounds, 1-Ring D006571 Heterocyclic Compounds D001087 Arabinonucleosides D009705 Nucleosides D009706 Nucleic Acids, Nucleotides, and Nucleosides D018943 Anthracyclines D009279 Naphthacenes D011084 Polycyclic Aromatic Hydrocarbons D006841 Hydrocarbons, Aromatic D006844 Hydrocarbons, Cyclic D011083 Polycyclic Compounds D000617 Aminoglycosides D006027 Glycosides D002241 Carbohydrates D011246 Pregnadienetriols D011245 Pregnadienes D011278 Pregnanes D013256 Steroids D000072473 Fused-Ring Compounds D013259 Steroids, Fluorinated D001557 Benzenesulfonates D001555 Benzene Derivatives D001190 Arylsulfonates D017739 Arylsulfonic Acids D013451 Sulfonic Acids D013456 Sulfur Acids D013457 Sulfur Compounds D005575 Formyltetrahydrofolates D013763 Tetrahydrofolates D005492 Folic Acid D011622 Pterins D011621 Pteridines D006574 Heterocyclic Compounds, 2-Ring D000072471 Heterocyclic Compounds, Fused-Ring D003067 Coenzymes D013438 Sulfhydryl Compounds D011687 Purines D000630 Aminopterin D011244 Pregnadienediols D014748 Vinca Alkaloids D046948 Secologanin Tryptamine Alkaloids D026121 Indole Alkaloids D000470 Alkaloids D007211 Indoles D054836 Indolizidines D007212 Indolizines D013812 Therapeutics
1 subjects
FG005 0 subjects
FG006 0 subjects 9 subjects
FG005 8 subjects
FG006 4 subjects 0 subjects
FG005 0 subjects
FG006 0 subjects 1 subjects
FG005 1 subjects
FG006 1 subjects 1 subjects
FG005 2 subjects
FG006 0 subjects 2 subjects
FG005 1 subjects
FG006 2 subjects 0 subjects
FG005 0 subjects
FG006 0 subjects 1 subjects
FG005 2 subjects
FG006 5 subjects 12
BG004 65
BG005 62
BG006 52
BG007 373 Between 18 and 65 years BG000 3 BG001 4 BG002 2 BG003 1 BG004 2 BG005 3 BG006 5 BG007 20
>=65 years BG000 0 BG001 0 BG002 0 BG003 0 BG004 0 BG005 0 BG006 0 BG007 0
10
± 4.8
BG003 11.4 ± 5.3
BG004 10.2 ± 5.1
BG005 10.6 ± 5.1
BG006 11.5 ± 5.1
BG007 10.3 ± 5.1 9
BG003 4
BG004 20
BG005 16
BG006 17
BG007 108 Male BG000 37 BG001 47 BG002 56 BG003 9 BG004 47 BG005 49 BG006 40 BG007 285
4
BG003 3
BG004 9
BG005 12
BG006 3
BG007 55 Not Hispanic or Latino BG000 47 BG001 53 BG002 58 BG003 10 BG004 58 BG005 47 BG006 52 BG007 325
Unknown or Not Reported BG000 2 BG001 0 BG002 3 BG003 0 BG004 0 BG005 6 BG006 2 BG007 13
1
BG003 0
BG004 0
BG005 0
BG006 0
BG007 1 Asian BG000 1 BG001 1 BG002 3 BG003 0 BG004 3 BG005 0 BG006 1 BG007 9
Native Hawaiian or Other Pacific Islander BG000 0 BG001 2 BG002 0 BG003 0 BG004 0 BG005 0 BG006 0 BG007 2
Black or African American BG000 3 BG001 5 BG002 9 BG003 2 BG004 6 BG005 5 BG006 11 BG007 41
White BG000 53 BG001 56 BG002 48 BG003 10 BG004 54 BG005 53 BG006 41 BG007 315
More than one race BG000 0 BG001 0 BG002 0 BG003 0 BG004 0 BG005 0 BG006 02 BG007 2
Unknown or Not Reported BG000 3 BG001 2 BG002 4 BG003 1 BG004 4 BG005 7 BG006 2 BG007 23
57
BG003 12
BG004 62
BG005 58
BG006 51
BG007 346 Canada Title Measurements BG000 5 BG001 3 BG002 6 BG003 1 BG004 4 BG005 4 BG006 4 BG007 27
Australia Title Measurements BG000 7 BG001 4 BG002 1 BG003 0 BG004 0 BG005 3 BG006 1 BG007 16
Switzerland Title Measurements BG000 0 BG001 1 BG002 1 BG003 0 BG004 1 BG005 0 BG006 1 BG007 4
12
OG004 66
OG005 63
OG006 52 63
(29 to 85)
OG004 82 (70 to 89)
OG005 84 (72 to 91)
OG006 90 (78 to 96)
OG002
OG003
OG005 A Cox model was used to assess evidence of a difference in event-free survival comparing A1+B1 ("1: no intensification") to A2 +B2 ("2: intensification"), while adjusting for the other intervention through stratification.
OG002 A2 (Disseminated, No CNS - CCG Mod BFM w/Intens Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
OG003 B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
OG004 B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/Intens Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
OG005 B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
OG006 B1 (NHL/BFM-95 w/Out Intens) Additional Enrollment Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
Units Counts Participants OG000 56 OG001 64 OG002 61 OG003 12 OG004 66 OG005 63 OG006 52
Title Denominators Categories Title Measurements OG000 96 (84 to 99) OG001 84 (72 to 91) OG002 88 (76 to 94) OG003 81 (42 to 95) OG004 85 (73 to 91) OG005 85 (74 to 92) OG006 92 (80 to 97)
0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 1 events 1 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 1 events 1 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 1 events 1 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 1 events 1 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 2 events 2 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 1 events 1 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 4 events 3 affected 66 at risk
EG005 5 events 4 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 1 events 1 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 1 events 1 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 16 events 12 affected 66 at risk
EG005 10 events 7 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 1 events 1 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 1 events 1 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 1 events 1 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 4 events 3 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 2 events 1 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 1 events 1 affected 52 at risk 0 events
0 affected
12 at risk
EG004 2 events 1 affected 66 at risk
EG005 4 events 2 affected 63 at risk
EG006 1 events 1 affected 52 at risk 0 events
0 affected
12 at risk
EG004 1 events 1 affected 66 at risk
EG005 1 events 1 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 1 events 1 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 1 events 1 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 1 events 1 affected 66 at risk
EG005 1 events 1 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 1 events 1 affected 52 at risk 1 events
1 affected
12 at risk
EG004 1 events 1 affected 66 at risk
EG005 1 events 1 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 69 events
10 affected
12 at risk
EG004 530 events 66 affected 66 at risk
EG005 496 events 62 affected 63 at risk
EG006 476 events 52 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 72 events
10 affected
12 at risk
EG004 556 events 66 affected 66 at risk
EG005 505 events 62 affected 63 at risk
EG006 476 events 52 affected 52 at risk 5 events
1 affected
12 at risk
EG004 39 events 15 affected 66 at risk
EG005 26 events 8 affected 63 at risk
EG006 29 events 9 affected 52 at risk 14 events
5 affected
12 at risk
EG004 114 events 36 affected 66 at risk
EG005 98 events 37 affected 63 at risk
EG006 79 events 27 affected 52 at risk 69 events
10 affected
12 at risk
EG004 520 events 66 affected 66 at risk
EG005 468 events 61 affected 63 at risk
EG006 476 events 52 affected 52 at risk 5 events
3 affected
12 at risk
EG004 22 events 14 affected 66 at risk
EG005 15 events 12 affected 63 at risk
EG006 12 events 9 affected 52 at risk 7 events
3 affected
12 at risk
EG004 51 events 30 affected 66 at risk
EG005 45 events 27 affected 63 at risk
EG006 30 events 28 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 1 events 1 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 1 events 1 affected 52 at risk 0 events
0 affected
12 at risk
EG004 1 events 1 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 2 events 2 affected 66 at risk
EG005 1 events 1 affected 63 at risk
EG006 2 events 2 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 63 events
10 affected
12 at risk
EG004 475 events 60 affected 66 at risk
EG005 427 events 60 affected 63 at risk
EG006 476 events 52 affected 52 at risk 62 events
10 affected
12 at risk
EG004 482 events 61 affected 66 at risk
EG005 436 events 61 affected 63 at risk
EG006 476 events 52 affected 52 at risk 0 events
0 affected
12 at risk
EG004 1 events 1 affected 66 at risk
EG005 1 events 1 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 7 events 7 affected 66 at risk
EG005 5 events 5 affected 63 at risk
EG006 11 events 9 affected 52 at risk 0 events
0 affected
12 at risk
EG004 4 events 4 affected 66 at risk
EG005 2 events 2 affected 63 at risk
EG006 2 events 2 affected 52 at risk 0 events
0 affected
12 at risk
EG004 2 events 2 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 6 events 6 affected 66 at risk
EG005 7 events 5 affected 63 at risk
EG006 6 events 6 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 1 events 1 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 1 events 1 affected 52 at risk 0 events
0 affected
12 at risk
EG004 6 events 6 affected 66 at risk
EG005 7 events 7 affected 63 at risk
EG006 5 events 4 affected 52 at risk 0 events
0 affected
12 at risk
EG004 3 events 3 affected 66 at risk
EG005 4 events 2 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 3 events 3 affected 66 at risk
EG005 5 events 4 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 2 events 1 affected 66 at risk
EG005 1 events 1 affected 63 at risk
EG006 0 events 0 affected 52 at risk 2 events
2 affected
12 at risk
EG004 7 events 5 affected 66 at risk
EG005 2 events 1 affected 63 at risk
EG006 2 events 2 affected 52 at risk 0 events
0 affected
12 at risk
EG004 8 events 6 affected 66 at risk
EG005 16 events 12 affected 63 at risk
EG006 4 events 4 affected 52 at risk 0 events
0 affected
12 at risk
EG004 1 events 1 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 1 events 1 affected 63 at risk
EG006 1 events 1 affected 52 at risk 1 events
1 affected
12 at risk
EG004 3 events 3 affected 66 at risk
EG005 2 events 2 affected 63 at risk
EG006 1 events 1 affected 52 at risk 0 events
0 affected
12 at risk
EG004 1 events 1 affected 66 at risk
EG005 1 events 1 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 9 events 3 affected 66 at risk
EG005 1 events 1 affected 63 at risk
EG006 1 events 1 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 1 events
1 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 2 events 2 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 2 events 2 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 1 events 1 affected 52 at risk 0 events
0 affected
12 at risk
EG004 1 events 1 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 1 events 1 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 2 events
1 affected
12 at risk
EG004 11 events 5 affected 66 at risk
EG005 5 events 5 affected 63 at risk
EG006 3 events 2 affected 52 at risk 0 events
0 affected
12 at risk
EG004 1 events 1 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 1 events 1 affected 66 at risk
EG005 1 events 1 affected 63 at risk
EG006 3 events 3 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 1 events 1 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 1 events 1 affected 66 at risk
EG005 4 events 2 affected 63 at risk
EG006 2 events 2 affected 52 at risk 2 events
1 affected
12 at risk
EG004 4 events 2 affected 66 at risk
EG005 1 events 1 affected 63 at risk
EG006 1 events 1 affected 52 at risk 0 events
0 affected
12 at risk
EG004 1 events 1 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 2 events 2 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 6 events 6 affected 52 at risk 0 events
0 affected
12 at risk
EG004 12 events 7 affected 66 at risk
EG005 2 events 2 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 1 events 1 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 1 events 1 affected 52 at risk 0 events
0 affected
12 at risk
EG004 9 events 8 affected 66 at risk
EG005 9 events 7 affected 63 at risk
EG006 4 events 4 affected 52 at risk 0 events
0 affected
12 at risk
EG004 10 events 7 affected 66 at risk
EG005 10 events 8 affected 63 at risk
EG006 8 events 3 affected 52 at risk 0 events
0 affected
12 at risk
EG004 6 events 4 affected 66 at risk
EG005 11 events 9 affected 63 at risk
EG006 4 events 3 affected 52 at risk 0 events
0 affected
12 at risk
EG004 2 events 1 affected 66 at risk
EG005 1 events 1 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 3 events 2 affected 66 at risk
EG005 5 events 3 affected 63 at risk
EG006 3 events 2 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 1 events 1 affected 66 at risk
EG005 1 events 1 affected 63 at risk
EG006 1 events 1 affected 52 at risk 0 events
0 affected
12 at risk
EG004 6 events 6 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 1 events 1 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 1 events
1 affected
12 at risk
EG004 14 events 9 affected 66 at risk
EG005 11 events 8 affected 63 at risk
EG006 10 events 8 affected 52 at risk 62 events
10 affected
12 at risk
EG004 481 events 63 affected 66 at risk
EG005 436 events 61 affected 63 at risk
EG006 476 events 52 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 1 events 1 affected 63 at risk
EG006 0 events 0 affected 52 at risk 2 events
2 affected
12 at risk
EG004 21 events 17 affected 66 at risk
EG005 24 events 20 affected 63 at risk
EG006 19 events 15 affected 52 at risk 0 events
0 affected
12 at risk
EG004 2 events 2 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 1 events 1 affected 52 at risk 1 events
1 affected
12 at risk
EG004 18 events 11 affected 66 at risk
EG005 17 events 12 affected 63 at risk
EG006 9 events 6 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 3 events 3 affected 52 at risk 0 events
0 affected
12 at risk
EG004 1 events 1 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 1 events 1 affected 52 at risk 0 events
0 affected
12 at risk
EG004 4 events 4 affected 66 at risk
EG005 2 events 1 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 1 events 1 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 1 events 1 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 2 events 2 affected 66 at risk
EG005 5 events 3 affected 63 at risk
EG006 2 events 2 affected 52 at risk 63 events
10 affected
12 at risk
EG004 505 events 65 affected 66 at risk
EG005 454 events 62 affected 63 at risk
EG006 476 events 52 affected 52 at risk 0 events
0 affected
12 at risk
EG004 1 events 1 affected 66 at risk
EG005 6 events 2 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 7 events 6 affected 66 at risk
EG005 5 events 4 affected 63 at risk
EG006 4 events 4 affected 52 at risk 63 events
10 affected
12 at risk
EG004 509 events 65 affected 66 at risk
EG005 468 events 62 affected 63 at risk
EG006 476 events 52 affected 52 at risk 67 events
10 affected
12 at risk
EG004 520 events 65 affected 66 at risk
EG005 482 events 62 affected 63 at risk
EG006 476 events 52 affected 52 at risk 0 events
0 affected
12 at risk
EG004 1 events 1 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 62 events
10 affected
12 at risk
EG004 481 events 63 affected 66 at risk
EG005 443 events 62 affected 63 at risk
EG006 476 events 52 affected 52 at risk 66 events
10 affected
12 at risk
EG004 486 events 64 affected 66 at risk
EG005 446 events 62 affected 63 at risk
EG006 476 events 52 affected 52 at risk 64 events
10 affected
12 at risk
EG004 488 events 64 affected 66 at risk
EG005 440 events 62 affected 63 at risk
EG006 476 events 52 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 2 events 2 affected 63 at risk
EG006 0 events 0 affected 52 at risk 62 events
10 affected
12 at risk
EG004 488 events 63 affected 66 at risk
EG005 445 events 61 affected 63 at risk
EG006 476 events 52 affected 52 at risk 65 events
10 affected
12 at risk
EG004 473 events 60 affected 66 at risk
EG005 425 events 60 affected 63 at risk
EG006 476 events 52 affected 52 at risk 0 events
0 affected
12 at risk
EG004 1 events 1 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 1 events 1 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 1 events 1 affected 52 at risk 1 events
1 affected
12 at risk
EG004 1 events 1 affected 66 at risk
EG005 6 events 4 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 1 events 1 affected 66 at risk
EG005 1 events 1 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 1 events 1 affected 66 at risk
EG005 6 events 2 affected 63 at risk
EG006 1 events 1 affected 52 at risk 0 events
0 affected
12 at risk
EG004 1 events 1 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 1 events 1 affected 52 at risk 3 events
2 affected
12 at risk
EG004 20 events 13 affected 66 at risk
EG005 30 events 16 affected 63 at risk
EG006 29 events 14 affected 52 at risk 1 events
1 affected
12 at risk
EG004 8 events 6 affected 66 at risk
EG005 2 events 2 affected 63 at risk
EG006 2 events 2 affected 52 at risk 0 events
0 affected
12 at risk
EG004 2 events 2 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 1 events 1 affected 52 at risk 0 events
0 affected
12 at risk
EG004 2 events 1 affected 66 at risk
EG005 7 events 4 affected 63 at risk
EG006 3 events 3 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 1 events
1 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 6 events 5 affected 63 at risk
EG006 1 events 1 affected 52 at risk 2 events
2 affected
12 at risk
EG004 13 events 13 affected 66 at risk
EG005 12 events 9 affected 63 at risk
EG006 16 events 9 affected 52 at risk 0 events
0 affected
12 at risk
EG004 4 events 4 affected 66 at risk
EG005 2 events 1 affected 63 at risk
EG006 2 events 2 affected 52 at risk 0 events
0 affected
12 at risk
EG004 11 events 10 affected 66 at risk
EG005 15 events 13 affected 63 at risk
EG006 27 events 19 affected 52 at risk 0 events
0 affected
12 at risk
EG004 3 events 3 affected 66 at risk
EG005 1 events 1 affected 63 at risk
EG006 2 events 1 affected 52 at risk 1 events
1 affected
12 at risk
EG004 15 events 13 affected 66 at risk
EG005 13 events 10 affected 63 at risk
EG006 26 events 20 affected 52 at risk 0 events
0 affected
12 at risk
EG004 7 events 7 affected 66 at risk
EG005 6 events 6 affected 63 at risk
EG006 4 events 4 affected 52 at risk 1 events
1 affected
12 at risk
EG004 4 events 4 affected 66 at risk
EG005 2 events 2 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 3 events 3 affected 66 at risk
EG005 4 events 2 affected 63 at risk
EG006 4 events 4 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 2 events 1 affected 63 at risk
EG006 2 events 2 affected 52 at risk 62 events
10 affected
12 at risk
EG004 477 events 61 affected 66 at risk
EG005 435 events 61 affected 63 at risk
EG006 476 events 52 affected 52 at risk 0 events
0 affected
12 at risk
EG004 1 events 1 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 1 events 1 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 1 events 1 affected 66 at risk
EG005 1 events 1 affected 63 at risk
EG006 0 events 0 affected 52 at risk 62 events
10 affected
12 at risk
EG004 478 events 61 affected 66 at risk
EG005 435 events 61 affected 63 at risk
EG006 476 events 52 affected 52 at risk 0 events
0 affected
12 at risk
EG004 2 events 2 affected 66 at risk
EG005 1 events 1 affected 63 at risk
EG006 1 events 1 affected 52 at risk 0 events
0 affected
12 at risk
EG004 2 events 2 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 1 events
1 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 2 events 2 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 1 events 1 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 2 events 2 affected 52 at risk 0 events
0 affected
12 at risk
EG004 1 events 1 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 1 events 1 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 1 events 1 affected 52 at risk 0 events
0 affected
12 at risk
EG004 1 events 1 affected 66 at risk
EG005 3 events 2 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 2 events 2 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 1 events 1 affected 52 at risk 0 events
0 affected
12 at risk
EG004 1 events 1 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 2 events 2 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 2 events 2 affected 63 at risk
EG006 1 events 1 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 2 events 2 affected 63 at risk
EG006 1 events 1 affected 52 at risk 0 events
0 affected
12 at risk
EG004 11 events 9 affected 66 at risk
EG005 5 events 5 affected 63 at risk
EG006 3 events 3 affected 52 at risk 0 events
0 affected
12 at risk
EG004 7 events 6 affected 66 at risk
EG005 7 events 5 affected 63 at risk
EG006 5 events 4 affected 52 at risk 0 events
0 affected
12 at risk
EG004 2 events 2 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 1 events 1 affected 52 at risk 62 events
10 affected
12 at risk
EG004 481 events 63 affected 66 at risk
EG005 437 events 61 affected 63 at risk
EG006 476 events 52 affected 52 at risk 0 events
0 affected
12 at risk
EG004 2 events 2 affected 66 at risk
EG005 1 events 1 affected 63 at risk
EG006 2 events 2 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 1 events 1 affected 63 at risk
EG006 1 events 1 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 1 events 1 affected 66 at risk
EG005 4 events 3 affected 63 at risk
EG006 1 events 1 affected 52 at risk 1 events
1 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 2 events 2 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 1 events 1 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 1 events 1 affected 52 at risk 1 events
1 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 1 events 1 affected 63 at risk
EG006 0 events 0 affected 52 at risk 1 events
1 affected
12 at risk
EG004 13 events 13 affected 66 at risk
EG005 5 events 4 affected 63 at risk
EG006 4 events 4 affected 52 at risk 1 events
1 affected
12 at risk
EG004 2 events 2 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 2 events 2 affected 52 at risk 0 events
0 affected
12 at risk
EG004 1 events 1 affected 66 at risk
EG005 2 events 1 affected 63 at risk
EG006 1 events 1 affected 52 at risk 1 events
1 affected
12 at risk
EG004 1 events 1 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 1 events 1 affected 52 at risk 2 events
1 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 3 events 3 affected 63 at risk
EG006 1 events 1 affected 52 at risk 5 events
3 affected
12 at risk
EG004 11 events 5 affected 66 at risk
EG005 7 events 5 affected 63 at risk
EG006 5 events 5 affected 52 at risk 0 events
0 affected
12 at risk
EG004 4 events 4 affected 66 at risk
EG005 2 events 2 affected 63 at risk
EG006 1 events 1 affected 52 at risk 3 events
2 affected
12 at risk
EG004 7 events 7 affected 66 at risk
EG005 11 events 7 affected 63 at risk
EG006 2 events 2 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 2 events 1 affected 52 at risk 0 events
0 affected
12 at risk
EG004 2 events 1 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 1 events 1 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 1 events 1 affected 52 at risk 0 events
0 affected
12 at risk
EG004 1 events 1 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 1 events
1 affected
12 at risk
EG004 11 events 8 affected 66 at risk
EG005 11 events 9 affected 63 at risk
EG006 7 events 5 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 1 events 1 affected 63 at risk
EG006 0 events 0 affected 52 at risk 1 events
1 affected
12 at risk
EG004 5 events 2 affected 66 at risk
EG005 9 events 7 affected 63 at risk
EG006 4 events 3 affected 52 at risk 0 events
0 affected
12 at risk
EG004 2 events 2 affected 66 at risk
EG005 1 events 1 affected 63 at risk
EG006 3 events 2 affected 52 at risk 0 events
0 affected
12 at risk
EG004 4 events 4 affected 66 at risk
EG005 4 events 4 affected 63 at risk
EG006 3 events 2 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 1 events 1 affected 52 at risk 3 events
1 affected
12 at risk
EG004 2 events 2 affected 66 at risk
EG005 1 events 1 affected 63 at risk
EG006 3 events 3 affected 52 at risk 0 events
0 affected
12 at risk
EG004 1 events 1 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 1 events
1 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 2 events 2 affected 52 at risk 1 events
1 affected
12 at risk
EG004 2 events 2 affected 66 at risk
EG005 1 events 1 affected 63 at risk
EG006 1 events 1 affected 52 at risk 62 events
10 affected
12 at risk
EG004 492 events 63 affected 66 at risk
EG005 450 events 61 affected 63 at risk
EG006 476 events 52 affected 52 at risk 0 events
0 affected
12 at risk
EG004 1 events 1 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 1 events 1 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 62 events
10 affected
12 at risk
EG004 480 events 63 affected 66 at risk
EG005 436 events 61 affected 63 at risk
EG006 476 events 52 affected 52 at risk 0 events
0 affected
12 at risk
EG004 1 events 1 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 2 events 2 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 1 events 1 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 1 events 1 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 1 events 1 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 1 events 1 affected 63 at risk
EG006 0 events 0 affected 52 at risk 0 events
0 affected
12 at risk
EG004 0 events 0 affected 66 at risk
EG005 0 events 0 affected 63 at risk
EG006 1 events 1 affected 52 at risk 4 events
2 affected
12 at risk
EG004 2 events 1 affected 66 at risk
EG005 9 events 6 affected 63 at risk
EG006 0 events 0 affected 52 at risk