Dexamethasone Compared With Prednisone During Induction Therapy and Methotrexate With or Without Leucovorin During Maintenance Therapy in Treating Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia
Official Title
High Risk B-Precursor Acute Lymphoblastic Leukemia (ALL)
Acronym
Not provided
Organization
Children's Oncology GroupNETWORK
Status Module
Record Verification Date
Apr 2021
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 29, 2003Actual
Primary Completion Date
Dec 31, 2010Actual
Completion Date
Mar 31, 2021Actual
First Submitted Date
Jan 9, 2004
First Submission Date that Met QC Criteria
Jan 12, 2004
First Posted Date
Jan 13, 2004Estimated
Results Waived
Not provided
Results First Submitted Date
Jul 10, 2015
Results First Submitted that Met QC Criteria
Jul 10, 2015
Results First Posted Date
Aug 6, 2015Estimated
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
Apr 2, 2021
Last Update Posted Date
Apr 27, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Children's Oncology GroupNETWORK
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
This randomized phase III trial is studying dexamethasone to see how well it works compared to prednisone during induction therapy. This trial is also studying methotrexate and leucovorin calcium to see how well they work compared to methotrexate alone during maintenance therapy in treating patients with newly diagnosed acute lymphoblastic leukemia (ALL). Drugs used in chemotherapy, such as dexamethasone, prednisone, methotrexate, and leucovorin calcium, work in different ways to stop cancer cells from dividing so they stop growing or die. Giving more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating acute lymphoblastic leukemia.
Detailed Description
OBJECTIVES:
I. Improve the outcome of children with high-risk acute lymphoblastic leukemia treated with 2 different chemotherapy regimens.
II. Determine the relative safety and efficacy of dexamethasone given for 14 days vs prednisone given for 28 days during induction.
III. Determine the relative safety and efficacy of high-dose methotrexate (5gm/m^2) with leucovorin rescue compared to escalating methotrexate without leucovorin rescue (Capizzi I) during interim maintenance I.
IV. Correlate Day 29 minimal residual disease (MRD) with event-free survival (EFS) and overall survival (OS).
V. Correlate early marrow response status with day-29 MRD status. VI. Improve outcome by identifying additional high risk patients by Day 29 MRD for treatment with fully augmented Berlin-Frankfurt-Munster (BFM).
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to early response (slow early response [SER] vs rapid early response [RER]). Induction therapy: Patients are randomized to 1 of 4 treatment arms.
ARM I: Patients receive cytarabine intrathecally (IT) on day 1, vincristine intravenously (IV) and daunorubicin IV on days 1, 8, 15, and 22, dexamethasone orally (PO) or IV twice daily (BID) on days 1-14, methotrexate (MTX) IT on days 8 and 29* and pegaspargase intramuscularly (IM) once on day 4, 5, or 6.
NOTE: *Patients with CNS3 disease (WBC > 5/mL in cerebrospinal fluid and positive for blasts on cytospin) also receive MTX IT on days 15 and 22.
ARM II: Patients receive induction therapy as in Arm I.
ARM III: Patients receive cytarabine, vincristine, daunorubicin, and pegaspargase as in Arm I. Patients also receive prednisone PO or IV BID on days 1-28 and MTX IT on days 8 and 29.
ARM IV: Patients receive induction therapy as in Arm III.
Patients in all arms are evaluated at day 29 of induction therapy. Patients with M3 disease are removed from study. Patients with M1 disease and less than 1% minimal residual disease (MRD) proceed to consolidation therapy beginning on day 36. Patients with M2 disease OR with MI disease and at least 1% MRD receive extended induction therapy for 2 additional weeks. Patients with SER disease and MLL rearrangements are removed from the study but may be eligible for treatment on protocol COG-AALL0031.
Extended induction therapy: Patients continue to receive therapy on the arm to which they were originally randomized.
ARMS I and II: Patients receive dexamethasone PO or IV BID on days 1-14, vincristine IV on days 1 and 8, daunorubicin IV on day 1 and pegaspargase IM on day 4, 5, or 6 and are then reevaluated.
ARMS III and IV: Patients receive prednisone PO or IV BID on days 1-14, and vincristine, daunorubicin, and pegaspargase as in Arms I and II and are then reevaluated.
Patients on all arms who have M1 disease and less than 1% MRD after extended induction proceed to consolidation therapy and continue as SER patients. All other patients are removed from study.
Consolidation therapy: All patients receive cyclophosphamide IV over 30 minutes on days 1 and 29, cytarabine IV or subcutaneously (SC) on days 1-4, 8-11, 29-32, and 36-39, mercaptopurine (MP) PO on days 1-14 and 29-42, vincristine IV on days 15, 22, 43, and 50; pegaspargase IM on days 15 and 43 and MTX* IT on days 1, 8, 15, and 22. Patients with testicular disease also receive radiotherapy to the testes.
NOTE: *Patients with CNS3 disease receive MTX on days 1 and 8 only.
Interim maintenance therapy I: Patients continue to receive treatment on the arm to which they were originally randomized.
ARM I: (escalating-dose MTX) Patients receive vincristine IV and escalating-dose MTX IV on days 1, 11, 21, 31, and 41, pegaspargase IM on days 2 and 22 and MTX IT on days 1 and 21.
ARM II: (high-dose MTX) Patients receive vincristine IV and high-dose methotrexate IV over 24 hours on days 1, 15, 29, and 43, MP PO on days 1-56 and IT MTX on days 1 and 29. Patients also receive leucovorin calcium IV every 6 hours for at least 3 doses, beginning 42 hours after start of each MTX infusion.
ARM III: (escalating-dose MTX) Patients receive interim maintenance I therapy as in Arm I.
ARM IV: (high-dose MTX) Patients receive interim maintenance I therapy as in Arm II.
DELAYED INTENSIFICATION THERAPY I: All patients receive vincristine IV on days 1, 8, 15, 43, and 50, dexamethasone PO or IV BID on days 1 to 21 for patients age 1 to 12 OR on days 1-7 and 15-21 for patients age 13 and over, doxorubicin IV on days 1, 8, and 15, pegaspargase IM on day 4, 5, or 6 AND day 43, cyclophosphamide IV over 30 minutes on day 29, cytarabine IV or SC on days 30-33 and 37-40, thioguanine PO on days 29-42 and MTX IT on days 1, 29, and 36.After delayed intensification I, SER patients proceed to interim maintenance II and delayed intensification II. RER patients proceed directly to maintenance.
INTERIM MAINTENANCE THERAPY II: All patients receive vincristine IV and MTX IV on days 1, 11, 21, 31, and 41, pegaspargase IM on days 2 and 22; and MTX IT on days 1 and 21. Patients then proceed to delayed intensification II.
DELAYED INTENSIFICATION THERAPY II: All patients receive therapy as in delayed intensification I, arm I. CNS3 patients also receive radiotherapy for 3-10 days, beginning on day 29. All other SER patients, patients with MLL rearrangements, and some patients pretreated with steroids (> 48 hours within the week prior to diagnosis) receive prophylactic cranial radiotherapy (CRT) for 8 days, beginning on day 29. Patients then proceed to maintenance therapy.
MAINTENANCE THERAPY: All patients receive vincristine IV on days 1, 29, and 57, dexamethasone PO BID on days 1-5, 29-33, and 57-61, MP PO on days 1-84, MTX IT on day 1*; and MTX PO on days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
NOTE: *RER (who did not undergo CRT) patients also receive MTX IT on day 29 for maintenance courses 1-4.
In all arms, maintenance therapy repeats every 12 weeks until total duration of therapy is 2 years from the start of interim maintenance I for female patients and 3 years from the start of interim maintenance I for male patients. Patients with testicular disease may receive testicular radiotherapy for 8 days during one of the first 3 courses of maintenance therapy. Patients are followed monthly for 1 year, every 2 months for 1 year, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.
Conditions Module
Conditions
Acute Lymphoblastic Leukemia
Adult B Acute Lymphoblastic Leukemia
Childhood B Acute Lymphoblastic Leukemia
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
3,154Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Arm I
Active Comparator
Patients in arm I receive intrathecal cytarabine in week 1; infusions of vincristine and daunorubicin once a week in weeks 1-4; dexamethasone by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate in weeks 2 and 5 or 2-5; and an injection of pegaspargase in week 1.
Drug: Cyclophosphamide
Drug: Cytarabine
Drug: Daunorubicin Hydrochloride
Drug: Dexamethasone
Drug: Doxorubicin Hydrochloride
Drug: Mercaptopurine
Drug: Methotrexate
Drug: Pegaspargase
Radiation: Radiation Therapy
Drug: Thioguanine
Drug: Vincristine Sulfate
Arm II
Active Comparator
Patients in arm II will receive intrathecal cytarabine in week 1; infusions of vincristine and daunorubicin once a week in weeks 1-4; dexamethasone by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate in weeks 2 and 5 or 2-5; and an injection of pegaspargase in week 1.
Drug: Cyclophosphamide
Drug: Cytarabine
Drug: Daunorubicin Hydrochloride
Drug: Dexamethasone
Drug: Doxorubicin Hydrochloride
Drug: Leucovorin Calcium
Drug: Mercaptopurine
Drug: Methotrexate
Drug: Pegaspargase
Radiation: Radiation Therapy
Drug: Thioguanine
Drug: Vincristine Sulfate
Arm III
Experimental
Patients in arm III will receive cytarabine, vincristine, daunorubicin, and pegaspargase as in groups one and two. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5.
Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Cyclophosphamide
Drug
Given IV
Arm I
Arm II
Arm III
Arm IV
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Comparison of the Increase in Cure Rate of High Risk ALL Without Causing More Serious Side Effects Between Interventions
Event Free Probability.
5 years
Secondary Outcomes
Measure
Description
Time Frame
Correlation of Minimal Residual Disease (MRD) Positive With Overall Survival (OS)
Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells, and negative with < 0.1 detectable leukemia cells.
5 Years
Correlation of Minimal Residual Disease (MRD) Negative With Overall Survival (OS).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Must be eligible for and enrolled on classification study COG-AALL03B1
Any WBC for patients age 10 to 30 OR patients who have received prior steroid therapy OR patients with testicular disease
Whit blood cell (WBC) criteria:
Age 1 - 9 years: WBC >= 50,000/uL
Age 10 - 30 years: any WBC
Prior steroid therapy: any WBC
Testicular disease: any WBC
Patients shall have had no other prior cytotoxic chemotherapy with the exception of steroids and intrathecal cytarabine
Patients receiving prior steroid therapy (as described in AALL03B1) are eligible for study; the dose and duration of previous steroid therapy should be carefully documented
All patients and/or their parents or legal guardians must sign a written informed consent
All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria:
Patients with Down syndrome are ineligible to enroll onto this study
Dexamethasone and Capizzi Methotrexate Patients < 10 Years
Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Netherlands
Puerto Rico
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: Cyclophosphamide
Drug: Cytarabine
Drug: Daunorubicin Hydrochloride
Drug: Dexamethasone
Drug: Doxorubicin Hydrochloride
Drug: Mercaptopurine
Drug: Methotrexate
Drug: Pegaspargase
Drug: Prednisone
Radiation: Radiation Therapy
Drug: Thioguanine
Drug: Vincristine Sulfate
Arm IV
Experimental
Patients in arm IV will receive cytarabine, vincristine, daunorubicin, and pegaspargase as in groups one and two. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5.
Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
Bone marrow MRD status is defined as negative with < .01 detectable leukemia cells.
5 years
Correlation of Early Marrow Response Status With MRD Positive.
Bone marrow status is defined as: M1: < 5% lymphoblasts; M2: 5-25% lymphoblasts; M3: > 25% lymphoblasts. Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells, and negative with < 0.1 detectable leukemia cells.
Day 29
Correlation of Early Marrow Response Status With MRD Negative.
Bone marrow status is defined as: M1: < 5% lymphoblasts; M2: 5-25% lymphoblasts; M3: > 25% lymphoblasts. Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells, and negative with < 0.1 detectable leukemia cells.
Day 29
Correlation of Minimal Residual Disease (MRD) Positive With Event Free Survival (EFS)
Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells.
5 years
Correlation of Minimal Residual Disease (MRD) Negative With Event Free Survival (EFS).
Bone marrow MRD status is defined as negative with < 0.1 detectable leukemia cells.
5 years
Birmingham
Alabama
35233
United States
USA Health Strada Patient Care Center
Mobile
Alabama
36604
United States
Banner Children's at Desert
Mesa
Arizona
85202
United States
Phoenix Childrens Hospital
Phoenix
Arizona
85016
United States
Banner University Medical Center - Tucson
Tucson
Arizona
85719
United States
Arkansas Children's Hospital
Little Rock
Arkansas
72202-3591
United States
University of Arkansas for Medical Sciences
Little Rock
Arkansas
72205
United States
Kaiser Permanente Downey Medical Center
Downey
California
90242
United States
City of Hope Comprehensive Cancer Center
Duarte
California
91010
United States
Loma Linda University Medical Center
Loma Linda
California
92354
United States
Miller Children's and Women's Hospital Long Beach
Long Beach
California
90806
United States
Children's Hospital Los Angeles
Los Angeles
California
90027
United States
Cedars Sinai Medical Center
Los Angeles
California
90048
United States
Mattel Children's Hospital UCLA
Los Angeles
California
90095
United States
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles
California
90095
United States
Valley Children's Hospital
Madera
California
93636
United States
UCSF Benioff Children's Hospital Oakland
Oakland
California
94609
United States
Kaiser Permanente-Oakland
Oakland
California
94611
United States
Children's Hospital of Orange County
Orange
California
92868
United States
Lucile Packard Children's Hospital Stanford University
Palo Alto
California
94304
United States
Sutter Medical Center Sacramento
Sacramento
California
95816
United States
University of California Davis Comprehensive Cancer Center
Sacramento
California
95817
United States
Rady Children's Hospital - San Diego
San Diego
California
92123
United States
UCSF Medical Center-Parnassus
San Francisco
California
94143
United States
Santa Barbara Cottage Hospital
Santa Barbara
California
93102
United States
Children's Hospital Colorado
Aurora
Colorado
80045
United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver
Colorado
80218
United States
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Denver
Colorado
80218
United States
University of Connecticut
Farmington
Connecticut
06030
United States
Connecticut Children's Medical Center
Hartford
Connecticut
06106
United States
Yale University
New Haven
Connecticut
06520
United States
Alfred I duPont Hospital for Children
Wilmington
Delaware
19803
United States
MedStar Georgetown University Hospital
Washington D.C.
District of Columbia
20007
United States
Children's National Medical Center
Washington D.C.
District of Columbia
20010
United States
Broward Health Medical Center
Fort Lauderdale
Florida
33316
United States
Lee Memorial Health System
Fort Myers
Florida
33901
United States
Golisano Children's Hospital of Southwest Florida
Fort Myers
Florida
33908
United States
University of Florida Health Science Center - Gainesville
Gainesville
Florida
32610
United States
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood
Florida
33021
United States
Nemours Children's Clinic-Jacksonville
Jacksonville
Florida
32207
United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami
Florida
33136
United States
Nicklaus Children's Hospital
Miami
Florida
33155
United States
Miami Cancer Institute
Miami
Florida
33176
United States
AdventHealth Orlando
Orlando
Florida
32803
United States
Nemours Children's Clinic - Orlando
Orlando
Florida
32806
United States
Orlando Health Cancer Institute
Orlando
Florida
32806
United States
Nemours Children's Hospital
Orlando
Florida
32827
United States
Nemours Children's Clinic - Pensacola
Pensacola
Florida
32504
United States
Sacred Heart Hospital
Pensacola
Florida
32504
United States
Johns Hopkins All Children's Hospital
St. Petersburg
Florida
33701
United States
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa
Florida
33607
United States
Saint Mary's Hospital
West Palm Beach
Florida
33407
United States
Children's Healthcare of Atlanta - Egleston
Atlanta
Georgia
30322
United States
Emory University Hospital/Winship Cancer Institute
Atlanta
Georgia
30322
United States
Augusta University Medical Center
Augusta
Georgia
30912
United States
Memorial Health University Medical Center
Savannah
Georgia
31404
United States
University of Hawaii Cancer Center
Honolulu
Hawaii
96813
United States
Tripler Army Medical Center
Honolulu
Hawaii
96859
United States
Saint Luke's Cancer Institute - Boise
Boise
Idaho
83712
United States
Lurie Children's Hospital-Chicago
Chicago
Illinois
60611
United States
Rush University Medical Center
Chicago
Illinois
60612
United States
University of Illinois
Chicago
Illinois
60612
United States
University of Chicago Comprehensive Cancer Center
Chicago
Illinois
60637
United States
Loyola University Medical Center
Maywood
Illinois
60153
United States
Advocate Children's Hospital-Oak Lawn
Oak Lawn
Illinois
60453
United States
Advocate Lutheran General Hospital
Park Ridge
Illinois
60068
United States
Southern Illinois University School of Medicine
Springfield
Illinois
62702
United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis
Indiana
46202
United States
Riley Hospital for Children
Indianapolis
Indiana
46202
United States
Saint Vincent Hospital and Health Care Center
Indianapolis
Indiana
46260
United States
Blank Children's Hospital
Des Moines
Iowa
50309
United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City
Iowa
52242
United States
University of Kansas Cancer Center
Kansas City
Kansas
66160
United States
University of Kentucky/Markey Cancer Center
Lexington
Kentucky
40536
United States
Norton Children's Hospital
Louisville
Kentucky
40202
United States
Tulane University Health Sciences Center
New Orleans
Louisiana
70112
United States
Children's Hospital New Orleans
New Orleans
Louisiana
70118
United States
Eastern Maine Medical Center
Bangor
Maine
04401
United States
Maine Children's Cancer Program
Scarborough
Maine
04074
United States
University of Maryland/Greenebaum Cancer Center
Baltimore
Maryland
21201
United States
Sinai Hospital of Baltimore
Baltimore
Maryland
21215
United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore
Maryland
21287
United States
Walter Reed National Military Medical Center
Bethesda
Maryland
20889-5600
United States
Tufts Children's Hospital
Boston
Massachusetts
02111
United States
Massachusetts General Hospital Cancer Center
Boston
Massachusetts
02114
United States
Baystate Medical Center
Springfield
Massachusetts
01199
United States
UMass Memorial Medical Center - University Campus
Worcester
Massachusetts
01655
United States
C S Mott Children's Hospital
Ann Arbor
Michigan
48109
United States
Wayne State University/Karmanos Cancer Institute
Detroit
Michigan
48201
United States
Ascension Saint John Hospital
Detroit
Michigan
48236
United States
Michigan State University Clinical Center
East Lansing
Michigan
48824-7016
United States
Hurley Medical Center
Flint
Michigan
48503
United States
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids
Michigan
49503
United States
Spectrum Health at Butterworth Campus
Grand Rapids
Michigan
49503
United States
Bronson Methodist Hospital
Kalamazoo
Michigan
49007
United States
Kalamazoo Center for Medical Studies
Kalamazoo
Michigan
49008
United States
Beaumont Children's Hospital-Royal Oak
Royal Oak
Michigan
48073
United States
William Beaumont Hospital-Royal Oak
Royal Oak
Michigan
48073
United States
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis
Minnesota
55404
United States
University of Minnesota/Masonic Cancer Center
Minneapolis
Minnesota
55455
United States
Mayo Clinic in Rochester
Rochester
Minnesota
55905
United States
Children's Hospital and Clinic-Saint Paul
Saint Paul
Minnesota
55102
United States
University of Mississippi Medical Center
Jackson
Mississippi
39216
United States
Columbia Regional
Columbia
Missouri
65201
United States
University of Missouri - Ellis Fischel
Columbia
Missouri
65212
United States
Children's Mercy Hospitals and Clinics
Kansas City
Missouri
64108
United States
Cardinal Glennon Children's Medical Center
St Louis
Missouri
63104
United States
Washington University School of Medicine
St Louis
Missouri
63110
United States
Children's Hospital and Medical Center of Omaha
Omaha
Nebraska
68114
United States
University of Nebraska Medical Center
Omaha
Nebraska
68198
United States
Nevada Cancer Research Foundation NCORP
Las Vegas
Nevada
89169
United States
Dartmouth Hitchcock Medical Center
Lebanon
New Hampshire
03756
United States
Hackensack University Medical Center
Hackensack
New Jersey
07601
United States
Saint Barnabas Medical Center
Livingston
New Jersey
07039
United States
Morristown Medical Center
Morristown
New Jersey
07960
United States
Saint Peter's University Hospital
New Brunswick
New Jersey
08901
United States
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick
New Jersey
08903
United States
Newark Beth Israel Medical Center
Newark
New Jersey
07112
United States
Saint Joseph's Regional Medical Center
Paterson
New Jersey
07503
United States
Overlook Hospital
Summit
New Jersey
07902
United States
University of New Mexico Cancer Center
Albuquerque
New Mexico
87102
United States
Albany Medical Center
Albany
New York
12208
United States
Brooklyn Hospital Center
Brooklyn
New York
11201
United States
Brookdale Hospital Medical Center
Brooklyn
New York
11212
United States
Maimonides Medical Center
Brooklyn
New York
11219
United States
Roswell Park Cancer Institute
Buffalo
New York
14263
United States
NYU Winthrop Hospital
Mineola
New York
11501
United States
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park
New York
11040
United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York
New York
10016
United States
Mount Sinai Hospital
New York
New York
10029
United States
NYP/Weill Cornell Medical Center
New York
New York
10065
United States
Stony Brook University Medical Center
Stony Brook
New York
11794
United States
State University of New York Upstate Medical University
Escherich CS, Chen W, Li Y, Yang W, Nishii R, Li Z, Raetz EA, Devidas M, Wu G, Nichols KE, Inaba H, Pui CH, Jeha S, Camitta BM, Larsen E, Hunger SP, Loh ML, Yang JJ. Germ line genetic NBN variation and predisposition to B-cell acute lymphoblastic leukemia in children. Blood. 2024 May 30;143(22):2270-2283. doi: 10.1182/blood.2023023336.
Karol SE, Mattano LA Jr, Yang W, Maloney KW, Smith C, Liu C, Ramsey LB, Fernandez CA, Chang TY, Neale G, Cheng C, Mardis E, Fulton R, Scheet P, San Lucas FA, Larsen EC, Loh ML, Raetz EA, Hunger SP, Devidas M, Relling MV. Genetic risk factors for the development of osteonecrosis in children under age 10 treated for acute lymphoblastic leukemia. Blood. 2016 Feb 4;127(5):558-64. doi: 10.1182/blood-2015-10-673848. Epub 2015 Nov 20.
Karol SE, Yang W, Van Driest SL, Chang TY, Kaste S, Bowton E, Basford M, Bastarache L, Roden DM, Denny JC, Larsen E, Winick N, Carroll WL, Cheng C, Pei D, Fernandez CA, Liu C, Smith C, Loh ML, Raetz EA, Hunger SP, Scheet P, Jeha S, Pui CH, Evans WE, Devidas M, Mattano LA Jr, Relling MV. Genetics of glucocorticoid-associated osteonecrosis in children with acute lymphoblastic leukemia. Blood. 2015 Oct 8;126(15):1770-6. doi: 10.1182/blood-2015-05-643601. Epub 2015 Aug 11.
Borowitz MJ, Wood BL, Devidas M, Loh ML, Raetz EA, Salzer WL, Nachman JB, Carroll AJ, Heerema NA, Gastier-Foster JM, Willman CL, Dai Y, Winick NJ, Hunger SP, Carroll WL, Larsen E. Prognostic significance of minimal residual disease in high risk B-ALL: a report from Children's Oncology Group study AALL0232. Blood. 2015 Aug 20;126(8):964-71. doi: 10.1182/blood-2015-03-633685. Epub 2015 Jun 29.
Fernandez CA, Smith C, Yang W, Date M, Bashford D, Larsen E, Bowman WP, Liu C, Ramsey LB, Chang T, Turner V, Loh ML, Raetz EA, Winick NJ, Hunger SP, Carroll WL, Onengut-Gumuscu S, Chen WM, Concannon P, Rich SS, Scheet P, Jeha S, Pui CH, Evans WE, Devidas M, Relling MV. HLA-DRB1*07:01 is associated with a higher risk of asparaginase allergies. Blood. 2014 Aug 21;124(8):1266-76. doi: 10.1182/blood-2014-03-563742. Epub 2014 Jun 26.
FG001
Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)
Patients non-randomly assigned to the DH (High Dose) regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
FG002
Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old
Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
FG003
Dexamethasone, High Dose Methotrexate (IM) < 10 Years
Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
FG004
Prednisone, Capizzi Methotrexate <10 Years
Patients in regimen PC (Prednisone, Capizzi) will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
FG005
Prednisone, Capezzi Methotrexate >= 10 Years
Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
FG006
Prednisone and High Dose Methotrexate < 10 Yrs Old
Patients randomly assigned to the PH (Prednisone, High Dose MTX) regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
FG007
Prednisone and High Dose Methotrexate >=10 Years
Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
FG008
Dexamethasone, High Dose Methotrexate (IM) >= 10 Years
Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
FG010
Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random)
Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
FG011
Prednisone and High Dose Methotrexate (Non Randomly Assigned)
Patients non-randomly assigned to the PH regimen based on one (or more) of the following: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal MTX in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
FG000246 subjects
FG001106 subjects
FG002296 subjects
FG003246 subjects
FG004232 subjects
FG005710 subjects
FG006246 subjects
FG007696 subjects
FG008302 subjects
FG00934 subjects
FG01012 subjects
FG01128 subjects
COMPLETED
FG000172 subjects
FG00157 subjects
FG002175 subjects
FG003168 subjects
FG004166 subjects
FG005397 subjects
FG006171 subjects
FG007401 subjects
FG008185 subjects
FG00916 subjects
FG0103 subjects
FG01110 subjects
NOT COMPLETED
FG00074 subjects
FG00149 subjects
FG002121 subjects
FG00378 subjects
FG00466 subjects
FG005313 subjects
FG00675 subjects
FG007295 subjects
FG008117 subjects
FG00918 subjects
FG0109 subjects
FG01118 subjects
Type
Comment
Reasons
Adverse Event
FG0006 subjects
FG0016 subjects
FG00220 subjects
FG0038 subjects
FG0044 subjects
FG00538 subjects
FG0063 subjects
FG00751 subjects
FG00815 subjects
FG0094 subjects
FG0102 subjects
FG0112 subjects
Death
FG0003 subjects
FG0015 subjects
FG00210 subjects
FG0032 subjects
FG004
Lost to Follow-up
FG0001 subjects
FG0011 subjects
FG0024 subjects
FG0031 subjects
FG004
Physician Decision
FG0002 subjects
FG0016 subjects
FG0025 subjects
FG0038 subjects
FG004
Pregnancy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0033 subjects
FG004
Withdrawal by Subject
FG00012 subjects
FG0013 subjects
FG0026 subjects
FG00310 subjects
FG004
Disease Progression, all other reasons
FG00017 subjects
FG0015 subjects
FG00233 subjects
FG0036 subjects
FG004
Patient off treatment
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0032 subjects
FG004
Ineligible or wrong diagnosis
FG0008 subjects
FG0013 subjects
FG0023 subjects
FG00310 subjects
FG004
Pt/Guardian refused RT therapy
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0032 subjects
FG004
Pt non compliant with therapy
FG0002 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Pt age out of range for treatment
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Insurance issues
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG004
MRD positive after extended ind
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Pt has very high risk ALL characteristic
FG00015 subjects
FG00111 subjects
FG00226 subjects
FG00318 subjects
Inevaluable
FG0001 subjects
FG0011 subjects
FG0024 subjects
FG0032 subjects
FG004
Other
FG0004 subjects
FG0012 subjects
FG0021 subjects
FG0031 subjects
FG004
Pt trying to find a BM donor
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Clinic chart lost unable to recreate
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Unsuccessful institutional transfer
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG004
specimen(s) not submitted
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG004
Pt went to transplant
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Pt received additional steroids
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Pt relocated
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG004
Institution Terminated
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Study Closure
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other complications
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Pt care terminated due to pt behavior
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Pt incarcerated
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Dexamethasone and Capizzi Methotrexate Patients < 10 Years
Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
BG001
Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)
Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
BG002
Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old
Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
BG003
Dexamethasone, High Dose Methotrexate (IM) < 10 Years
Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
BG004
Prednisone, Capizzi Methotrexate <10 Years
Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
BG005
Prednisone, Capezzi Methotrexate >= 10 Years
Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
BG006
Prednisone and High Dose Methotrexate < 10 Yrs Old
Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
BG007
Prednisone and High Dose Methotrexate >=10 Years
Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
BG008
Dexamethasone, High Dose Methotrexate (IM) >= 10 Years
Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
BG010
Dexamethasone, Capizzi Methotrexate Down Syndrome
Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
BG011
Prednisone and High Dose Methotrexate (Non Randomly Assigned)
Patients non-randomly assigned to the PH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth
BG012
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000246
BG001106
BG002296
BG003246
BG004232
BG005710
BG006246
BG007696
BG008302
BG00934
BG01012
BG01128
BG0123154
Baseline Measures
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
BG000246
BG00196
BG002275
BG003
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG0004.0± 2.3
BG0019.3± 6.0
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000129
BG00131
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00054
BG00122
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
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
Comparison of the Increase in Cure Rate of High Risk ALL Without Causing More Serious Side Effects Between Interventions
Event Free Probability.
Group "Prednisone and High Dose MTX (non-random)" who either had EFS events occur before 5 years or did not have minimum 5 years of follow-up.
Posted
Number
95% Confidence Interval
percentage of participants
5 years
ID
Title
Description
OG000
Dexamethasone and Capizzi Methotrexate Patients < 10 Years
Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
OG001
Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)
Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
OG002
Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old
Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
OG003
Dexamethasone, High Dose Methotrexate (IM) < 10 Years
Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
OG004
Prednisone, Capizzi Methotrexate <10 Years
Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
OG005
Prednisone, Capezzi Methotrexate >= 10 Years
Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
OG006
Predisone and High Dose Methotrexate < 10 Yrs Old
Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
OG007
Prenisone and High Dose Methotrexate >=10 Years
Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
OG008
Dexamethasone, High Dose Methotrexate (IM) >= 10 Years
Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
OG009
Prenisone, Capezzi Methotrexate (Down's Syndrome)
Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
OG010
Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random)
Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
Units
Counts
Participants
OG000218
OG00190
OG002261
OG003
Title
Denominators
Categories
Title
Measurements
OG00083.2(76.6 to 89.9)
OG00181.6(71.2 to 91.9)
OG00269.1(63.1 to 75.2)
OG003
Secondary
Correlation of Minimal Residual Disease (MRD) Positive With Overall Survival (OS)
Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells, and negative with < 0.1 detectable leukemia cells.
Groups "Prednisone Capizzi MTX (Down's Syndrome)", "Dexamethasone, Capizzi MTX (non-random)" & "Prednisone and High Dose MTX (non-random) are not included in this OM as no patients survived the 5 year window for analysis. Cohort of MRD Positive patients who either had EFS/OS events occur before 5 years or did not have minimum 5 years of follow-up.
Posted
Number
95% Confidence Interval
percentage of participants
5 Years
ID
Title
Description
OG000
Dexamethasone and Capizzi Methotrexate Patients < 10 Years
Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
OG001
Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)
Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
Secondary
Correlation of Minimal Residual Disease (MRD) Negative With Overall Survival (OS).
Bone marrow MRD status is defined as negative with < .01 detectable leukemia cells.
Patients on Arm/Group "Prednisone and High Dose Methotrexate (non randomly assigned)" are not included in the OM as there were no survivors for the 5 year duration. Cohort of MRD Negative patients some of whom have had EFS/OS events after 5 years or have minimum 5 years of follow-up.
Posted
Number
95% Confidence Interval
percentage of participants
5 years
ID
Title
Description
OG000
Dexamethasone and Capizzi Methotrexate Patients < 10 Years
Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
OG001
Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)
Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
Secondary
Correlation of Early Marrow Response Status With MRD Positive.
Bone marrow status is defined as: M1: < 5% lymphoblasts; M2: 5-25% lymphoblasts; M3: > 25% lymphoblasts. Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells, and negative with < 0.1 detectable leukemia cells.
Posted
Number
participants
Day 29
ID
Title
Description
OG000
Dexamethasone and Capizzi Methotrexate Patients < 10 Years
Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
OG001
Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)
Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
Secondary
Correlation of Early Marrow Response Status With MRD Negative.
Bone marrow status is defined as: M1: < 5% lymphoblasts; M2: 5-25% lymphoblasts; M3: > 25% lymphoblasts. Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells, and negative with < 0.1 detectable leukemia cells.
Posted
Number
participants
Day 29
ID
Title
Description
OG000
Dexamethasone and Capizzi Methotrexate Patients < 10 Years
Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
OG001
Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)
Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
Secondary
Correlation of Minimal Residual Disease (MRD) Positive With Event Free Survival (EFS)
Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells.
Groups "Prednisone Capizzi MTX (Down's Syndrome)", "Dexamethasone, Capizzi MTX (non-random)" & "Prednisone and High Dose MTX (non-random) are not included in this OM as no patients survived the 5 year window for analysis. Cohort of MRD Positive patients who either had EFS/OS events occur before 5 years or did not have minimum 5 years of follow-up.
Posted
Number
95% Confidence Interval
percentage of participants
5 years
ID
Title
Description
OG000
Dexamethasone and Capizzi Methotrexate Patients < 10 Years
Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
OG001
Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)
Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
Secondary
Correlation of Minimal Residual Disease (MRD) Negative With Event Free Survival (EFS).
Bone marrow MRD status is defined as negative with < 0.1 detectable leukemia cells.
Group "Prednisone and High Dose MTX (non-random)" who either had EFS/OS events occur before 5 years or did not have minimum 5 years of follow-up.
Posted
Number
95% Confidence Interval
percentage of participants
5 years
ID
Title
Description
OG000
Dexamethasone and Capizzi Methotrexate Patients < 10 Years
Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
OG001
Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)
Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
Time Frame
Not provided
Description
SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Dexamethasone and Capizzi Methotrexate Patients < 10 Years
Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
16
218
215
218
EG001
Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)
Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
17
90
87
90
EG002
Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old
Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
42
261
250
261
EG003
Dexamethasone, High Dose Methotrexate (IM) < 10 Years
Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
25
206
203
206
EG004
Prednisone, Capizzi Methotrexate <10 Years
Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
20
214
212
214
EG005
Prednisone, Capezzi Methotrexate >= 10 Years
Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
64
598
564
598
EG006
Prednisone and High Dose Methotrexate < 10 Yrs Old
Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
16
213
204
213
EG007
Prednisone and High Dose Methotrexate >=10 Years
Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
67
601
576
601
EG008
Dexamethasone, High Dose Methotrexate (IM) >= 10 Years
Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
3
30
30
30
EG010
Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random)
Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
3
9
9
9
EG011
Prednisone and High Dose Methotrexate (Non Randomly Assigned)
Patients non-randomly assigned to the PH regimen based on one (or more) of the following: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal MTX in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
1
23
20
23
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal distension
Gastrointestinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG0030 events0 affected206 at risk
EG0040 events0 affected214 at risk
EG0050 events0 affected598 at risk
EG0060 events0 affected213 at risk
EG0071 events1 affected601 at risk
EG0080 events0 affected262 at risk
EG0090 events0 affected30 at risk
EG0100 events0 affected9 at risk
EG0110 events0 affected23 at risk
Abdominal pain
Gastrointestinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Abdominal soft tissue necrosis
Musculoskeletal and connective tissue disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Acidosis
Metabolism and nutrition disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Acute kidney injury
Renal and urinary disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0023 events3 affected261 at risk
EG003
Adrenal insufficiency
Endocrine disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Adult respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Alanine aminotransferase increased
Investigations
CTCv4
EG0003 events1 affected218 at risk
EG0010 events0 affected90 at risk
EG0022 events2 affected261 at risk
EG003
Alkalosis
Metabolism and nutrition disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Allergic reaction
Immune system disorders
CTCv4
EG0001 events1 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Amnesia
Nervous system disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Anaphylaxis
Immune system disorders
CTCv4
EG0001 events1 affected218 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Anemia
Blood and lymphatic system disorders
CTCv4
EG0001 events1 affected218 at risk
EG0010 events0 affected90 at risk
EG0022 events2 affected261 at risk
EG003
Anorexia
Metabolism and nutrition disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Appendicitis perforated
Infections and infestations
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Ascites
Gastrointestinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Aspartate aminotransferase increased
Investigations
CTCv4
EG0001 events1 affected218 at risk
EG0011 events1 affected90 at risk
EG0022 events2 affected261 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Avascular necrosis
Musculoskeletal and connective tissue disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Blood and lymphatic system disorders - Other, specify
Blood and lymphatic system disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Blood bilirubin increased
Investigations
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0024 events3 affected261 at risk
EG003
Bone marrow hypocellular
Blood and lymphatic system disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Bronchial infection
Infections and infestations
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Bronchopulmonary hemorrhage
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Capillary leak syndrome
Vascular disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Cardiac arrest
Cardiac disorders
CTCv4
EG0000 events0 affected218 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Cardiac disorders - Other, specify
Cardiac disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Cholesterol high
Investigations
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Cognitive disturbance
Nervous system disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Colitis
Gastrointestinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Colonic perforation
Gastrointestinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Confusion
Psychiatric disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Constipation
Gastrointestinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Creatinine increased
Investigations
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Cystitis noninfective
Renal and urinary disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Dehydration
Metabolism and nutrition disorders
CTCv4
EG0000 events0 affected218 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Depressed level of consciousness
Nervous system disorders
CTCv4
EG0000 events0 affected218 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Diarrhea
Gastrointestinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Disseminated intravascular coagulation
Blood and lymphatic system disorders
CTCv4
EG0000 events0 affected218 at risk
EG0012 events2 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Dizziness
Nervous system disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Dysphasia
Nervous system disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Dyspnea
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Encephalopathy
Nervous system disorders
CTCv4
EG0001 events1 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Enterocolitis
Gastrointestinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Enterocolitis infectious
Infections and infestations
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Erythema multiforme
Skin and subcutaneous tissue disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Esophagitis
Gastrointestinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Eye disorders - Other, specify
Eye disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Facial nerve disorder
Nervous system disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
CTCv4
EG0007 events4 affected218 at risk
EG0010 events0 affected90 at risk
EG0022 events2 affected261 at risk
EG003
Fever
General disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
General disorders and administration site conditions - Other, specify
General disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Generalized muscle weakness
Musculoskeletal and connective tissue disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
GGT increased
Investigations
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Glucose intolerance
Metabolism and nutrition disorders
CTCv4
EG0000 events0 affected218 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Headache
Nervous system disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Hematuria
Renal and urinary disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Hemolysis
Blood and lymphatic system disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Hepatic failure
Hepatobiliary disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0024 events4 affected261 at risk
EG003
Hepatic pain
Hepatobiliary disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Hepatitis viral
Infections and infestations
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Hepatobiliary disorders - Other, specify
Hepatobiliary disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0022 events2 affected261 at risk
EG003
Hypercalcemia
Metabolism and nutrition disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Hyperglycemia
Metabolism and nutrition disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0022 events2 affected261 at risk
EG003
Hyperkalemia
Metabolism and nutrition disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Hypermagnesemia
Metabolism and nutrition disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Hypernatremia
Metabolism and nutrition disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Hypertension
Vascular disorders
CTCv4
EG0001 events1 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Hypertriglyceridemia
Metabolism and nutrition disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Hyperuricemia
Metabolism and nutrition disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Hypoalbuminemia
Metabolism and nutrition disorders
CTCv4
EG0000 events0 affected218 at risk
EG0012 events2 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Hypocalcemia
Metabolism and nutrition disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Hypoglycemia
Metabolism and nutrition disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Hypokalemia
Metabolism and nutrition disorders
CTCv4
EG0000 events0 affected218 at risk
EG0011 events1 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Hyponatremia
Metabolism and nutrition disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Hypotension
Vascular disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0022 events2 affected261 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0022 events2 affected261 at risk
EG003
Ileal hemorrhage
Gastrointestinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Ileal perforation
Gastrointestinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Infections and infestations - Other, specify
Infections and infestations
CTCv4
EG0007 events3 affected218 at risk
EG0016 events6 affected90 at risk
EG00213 events11 affected261 at risk
EG003
INR increased
Investigations
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Intracranial hemorrhage
Nervous system disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Investigations - Other, specify
Investigations
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Iron overload
Metabolism and nutrition disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Jejunal perforation
Gastrointestinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Left ventricular systolic dysfunction
Cardiac disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Leukemia secondary to oncology chemotherapy
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Leukoencephalopathy
Nervous system disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Lip infection
Infections and infestations
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Lipase increased
Investigations
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Lower gastrointestinal hemorrhage
Gastrointestinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Lung infection
Infections and infestations
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Lymphocyte count decreased
Investigations
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Mucositis oral
Gastrointestinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Multi-organ failure
General disorders
CTCv4
EG0001 events1 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Muscle weakness lower limb
Musculoskeletal and connective tissue disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Myocardial infarction
Cardiac disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Nausea
Gastrointestinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Nervous system disorders - Other, specify
Nervous system disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0022 events2 affected261 at risk
EG003
Neutrophil count decreased
Investigations
CTCv4
EG0002 events2 affected218 at risk
EG0011 events1 affected90 at risk
EG0025 events5 affected261 at risk
EG003
Oral pain
Gastrointestinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Osteoporosis
Musculoskeletal and connective tissue disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Otitis media
Infections and infestations
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Pain
General disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Palmar-plantar erythrodysesthesia syndrome
Skin and subcutaneous tissue disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Pancreatitis
Gastrointestinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Pelvic soft tissue necrosis
Musculoskeletal and connective tissue disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Peripheral motor neuropathy
Nervous system disorders
CTCv4
EG0000 events0 affected218 at risk
EG0011 events1 affected90 at risk
EG0023 events3 affected261 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
CTCv4
EG0000 events0 affected218 at risk
EG0011 events1 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Personality change
Psychiatric disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Pharyngitis
Infections and infestations
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Platelet count decreased
Investigations
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0024 events4 affected261 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Portal hypertension
Hepatobiliary disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Pregnancy, puerperium and perinatal conditions - Other, specify
Pregnancy, puerperium and perinatal conditions
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Purpura
Skin and subcutaneous tissue disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Rectal mucositis
Gastrointestinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Renal and urinary disorders - Other, specify
Renal and urinary disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Respiratory, thoracic and mediastinal disorders - Other, specify
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Seizure
Nervous system disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Sepsis
Infections and infestations
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Serum amylase increased
Investigations
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Sinus disorder
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Sinus tachycardia
Cardiac disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Skin infection
Infections and infestations
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Skin ulceration
Skin and subcutaneous tissue disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Small intestinal perforation
Gastrointestinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Soft tissue infection
Infections and infestations
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Soft tissue necrosis lower limb
Musculoskeletal and connective tissue disorders
CTCv4
EG0000 events0 affected218 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Stevens-Johnson syndrome
Skin and subcutaneous tissue disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Stroke
Nervous system disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Sudden death NOS
General disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Thromboembolic event
Vascular disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Tracheal mucositis
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Treatment related secondary malignancy
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Trigeminal nerve disorder
Nervous system disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Tumor lysis syndrome
Metabolism and nutrition disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Typhlitis
Gastrointestinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0022 events2 affected261 at risk
EG003
Upper respiratory infection
Infections and infestations
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Urinary tract infection
Infections and infestations
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Vagus nerve disorder
Nervous system disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Vascular access complication
Injury, poisoning and procedural complications
CTCv4
EG0001 events1 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Vascular disorders - Other, specify
Vascular disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0023 events3 affected261 at risk
EG003
Ventricular tachycardia
Cardiac disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Vomiting
Gastrointestinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Weight gain
Investigations
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Weight loss
Investigations
CTCv4
EG0000 events0 affected218 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected261 at risk
EG003
White blood cell decreased
Investigations
CTCv4
EG0001 events1 affected218 at risk
EG0011 events1 affected90 at risk
EG0023 events3 affected261 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal distension
Gastrointestinal disorders
CTCv4
EG0002 events2 affected218 at risk
EG0013 events3 affected90 at risk
EG0021 events1 affected261 at risk
EG0030 events0 affected206 at risk
EG0040 events0 affected214 at risk
EG0050 events0 affected598 at risk
EG0063 events2 affected213 at risk
EG0071 events1 affected601 at risk
EG0081 events1 affected262 at risk
EG0090 events0 affected30 at risk
EG0100 events0 affected9 at risk
EG0110 events0 affected23 at risk
Abdominal infection
Infections and infestations
CTCv4
EG0002 events2 affected218 at risk
EG0010 events0 affected90 at risk
EG0022 events2 affected261 at risk
EG003
Abdominal pain
Gastrointestinal disorders
CTCv4
EG00013 events12 affected218 at risk
EG00115 events12 affected90 at risk
EG00245 events38 affected261 at risk
EG003
Accessory nerve disorder
Nervous system disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Acidosis
Metabolism and nutrition disorders
CTCv4
EG0007 events5 affected218 at risk
EG0014 events3 affected90 at risk
EG0024 events4 affected261 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
CTCv4
EG0005 events4 affected218 at risk
EG0016 events5 affected90 at risk
EG00218 events11 affected261 at risk
EG003
Acute kidney injury
Renal and urinary disorders
CTCv4
EG0002 events2 affected218 at risk
EG0012 events2 affected90 at risk
EG00213 events12 affected261 at risk
EG003
Adrenal insufficiency
Endocrine disorders
CTCv4
EG0000 events0 affected218 at risk
EG0011 events1 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Adult respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0023 events3 affected261 at risk
EG003
Agitation
Psychiatric disorders
CTCv4
EG0002 events2 affected218 at risk
EG0012 events2 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Alanine aminotransferase increased
Investigations
CTCv4
EG000272 events96 affected218 at risk
EG00188 events33 affected90 at risk
EG002305 events122 affected261 at risk
EG003
Alcohol intolerance
Metabolism and nutrition disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Alkaline phosphatase increased
Investigations
CTCv4
EG0003 events3 affected218 at risk
EG0013 events3 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Alkalosis
Metabolism and nutrition disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Allergic reaction
Immune system disorders
CTCv4
EG0001 events1 affected218 at risk
EG0012 events2 affected90 at risk
EG0022 events2 affected261 at risk
EG003
Allergic rhinitis
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Anal fistula
Gastrointestinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Anal mucositis
Gastrointestinal disorders
CTCv4
EG0001 events1 affected218 at risk
EG0010 events0 affected90 at risk
EG0026 events6 affected261 at risk
EG003
Anal necrosis
Gastrointestinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Anal pain
Gastrointestinal disorders
CTCv4
EG0001 events1 affected218 at risk
EG0011 events1 affected90 at risk
EG0022 events2 affected261 at risk
EG003
Anaphylaxis
Immune system disorders
CTCv4
EG00033 events30 affected218 at risk
EG0019 events9 affected90 at risk
EG00240 events36 affected261 at risk
EG003
Anemia
Blood and lymphatic system disorders
CTCv4
EG000147 events71 affected218 at risk
EG00171 events33 affected90 at risk
EG002128 events70 affected261 at risk
EG003
Anorectal infection
Infections and infestations
CTCv4
EG0002 events2 affected218 at risk
EG0013 events2 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Anorexia
Metabolism and nutrition disorders
CTCv4
EG00021 events16 affected218 at risk
EG00119 events17 affected90 at risk
EG00268 events43 affected261 at risk
EG003
Anxiety
Psychiatric disorders
CTCv4
EG0000 events0 affected218 at risk
EG0014 events3 affected90 at risk
EG0028 events7 affected261 at risk
EG003
Apnea
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Appendicitis
Infections and infestations
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Appendicitis perforated
Infections and infestations
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Arachnoiditis
Nervous system disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
CTCv4
EG0001 events1 affected218 at risk
EG00113 events3 affected90 at risk
EG00214 events12 affected261 at risk
EG003
Ascites
Gastrointestinal disorders
CTCv4
EG0001 events1 affected218 at risk
EG0012 events2 affected90 at risk
EG0023 events3 affected261 at risk
EG003
Aspartate aminotransferase increased
Investigations
CTCv4
EG00066 events44 affected218 at risk
EG00135 events22 affected90 at risk
EG00291 events63 affected261 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Asystole
Cardiac disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Ataxia
Nervous system disorders
CTCv4
EG0000 events0 affected218 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Atrial flutter
Cardiac disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Avascular necrosis
Musculoskeletal and connective tissue disorders
CTCv4
EG0001 events1 affected218 at risk
EG00120 events6 affected90 at risk
EG00222 events19 affected261 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
CTCv4
EG0002 events2 affected218 at risk
EG0016 events6 affected90 at risk
EG00219 events18 affected261 at risk
EG003
Biliary tract infection
Infections and infestations
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Bladder anastomotic leak
Injury, poisoning and procedural complications
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Bladder infection
Infections and infestations
CTCv4
EG0002 events2 affected218 at risk
EG0011 events1 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Bladder spasm
Renal and urinary disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Blood and lymphatic system disorders - Other, specify
Blood and lymphatic system disorders
CTCv4
EG0007 events3 affected218 at risk
EG0011 events1 affected90 at risk
EG0023 events3 affected261 at risk
EG003
Blood antidiuretic hormone abnormal
Investigations
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Blood bilirubin increased
Investigations
CTCv4
EG00017 events15 affected218 at risk
EG00117 events13 affected90 at risk
EG00283 events47 affected261 at risk
EG003
Blood corticotrophin decreased
Investigations
CTCv4
EG0000 events0 affected218 at risk
EG0011 events1 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Blurred vision
Eye disorders
CTCv4
EG0000 events0 affected218 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Bone infection
Infections and infestations
CTCv4
EG0001 events1 affected218 at risk
EG0012 events2 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Bone marrow hypocellular
Blood and lymphatic system disorders
CTCv4
EG0000 events0 affected218 at risk
EG0011 events1 affected90 at risk
EG0023 events2 affected261 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
CTCv4
EG0001 events1 affected218 at risk
EG0010 events0 affected90 at risk
EG00211 events10 affected261 at risk
EG003
Breast pain
Reproductive system and breast disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Bronchial infection
Infections and infestations
CTCv4
EG0003 events2 affected218 at risk
EG0011 events1 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Bronchial obstruction
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Bronchopulmonary hemorrhage
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0001 events1 affected218 at risk
EG0012 events2 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0001 events1 affected218 at risk
EG0011 events1 affected90 at risk
EG0022 events1 affected261 at risk
EG003
Burn
Injury, poisoning and procedural complications
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Buttock pain
Musculoskeletal and connective tissue disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Capillary leak syndrome
Vascular disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0022 events2 affected261 at risk
EG003
Cardiac arrest
Cardiac disorders
CTCv4
EG0001 events1 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Cardiac disorders - Other, specify
Cardiac disorders
CTCv4
EG0000 events0 affected218 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Cataract
Eye disorders
CTCv4
EG0000 events0 affected218 at risk
EG0011 events1 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Catheter related infection
Infections and infestations
CTCv4
EG00025 events16 affected218 at risk
EG00119 events10 affected90 at risk
EG0029 events9 affected261 at risk
EG003
CD4 lymphocytes decreased
Investigations
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Central nervous system necrosis
Nervous system disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Cerebrospinal fluid leakage
Nervous system disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Chest wall pain
Musculoskeletal and connective tissue disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Chills
General disorders
CTCv4
EG0001 events1 affected218 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Cholecystitis
Hepatobiliary disorders
CTCv4
EG0001 events1 affected218 at risk
EG0010 events0 affected90 at risk
EG0023 events3 affected261 at risk
EG003
Cholesterol high
Investigations
CTCv4
EG0003 events2 affected218 at risk
EG0012 events2 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Chronic kidney disease
Renal and urinary disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Cognitive disturbance
Nervous system disorders
CTCv4
EG0000 events0 affected218 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Colitis
Gastrointestinal disorders
CTCv4
EG0007 events6 affected218 at risk
EG0013 events2 affected90 at risk
EG0029 events9 affected261 at risk
EG003
Colonic hemorrhage
Gastrointestinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Colonic perforation
Gastrointestinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Confusion
Psychiatric disorders
CTCv4
EG0000 events0 affected218 at risk
EG0013 events3 affected90 at risk
EG0024 events4 affected261 at risk
EG003
Conjunctivitis infective
Infections and infestations
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Constipation
Gastrointestinal disorders
CTCv4
EG0005 events5 affected218 at risk
EG0012 events2 affected90 at risk
EG0022 events1 affected261 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0003 events3 affected218 at risk
EG0012 events2 affected90 at risk
EG0024 events4 affected261 at risk
EG003
CPK increased
Investigations
CTCv4
EG0001 events1 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Creatinine increased
Investigations
CTCv4
EG0001 events1 affected218 at risk
EG0010 events0 affected90 at risk
EG00211 events9 affected261 at risk
EG003
Cystitis noninfective
Renal and urinary disorders
CTCv4
EG0001 events1 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Death NOS
General disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Dehydration
Metabolism and nutrition disorders
CTCv4
EG00012 events9 affected218 at risk
EG00121 events13 affected90 at risk
EG00241 events34 affected261 at risk
EG003
Delayed puberty
Endocrine disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Delirium
Psychiatric disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Dental caries
Gastrointestinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Depressed level of consciousness
Nervous system disorders
CTCv4
EG0003 events3 affected218 at risk
EG0012 events2 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Depression
Psychiatric disorders
CTCv4
EG0002 events2 affected218 at risk
EG0012 events2 affected90 at risk
EG00223 events15 affected261 at risk
EG003
Dermatitis radiation
Injury, poisoning and procedural complications
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Device related infection
Infections and infestations
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Diarrhea
Gastrointestinal disorders
CTCv4
EG00022 events18 affected218 at risk
EG0017 events7 affected90 at risk
EG00224 events20 affected261 at risk
EG003
Disseminated intravascular coagulation
Blood and lymphatic system disorders
CTCv4
EG0000 events0 affected218 at risk
EG0011 events1 affected90 at risk
EG0024 events4 affected261 at risk
EG003
Dizziness
Nervous system disorders
CTCv4
EG0000 events0 affected218 at risk
EG0012 events1 affected90 at risk
EG0022 events2 affected261 at risk
EG003
Dry mouth
Gastrointestinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Duodenal hemorrhage
Gastrointestinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Duodenal infection
Infections and infestations
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Duodenal obstruction
Gastrointestinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Duodenal ulcer
Gastrointestinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Dysarthria
Nervous system disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Dyspepsia
Gastrointestinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Dysphagia
Gastrointestinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0013 events3 affected90 at risk
EG0024 events4 affected261 at risk
EG003
Dysphasia
Nervous system disorders
CTCv4
EG0001 events1 affected218 at risk
EG0012 events2 affected90 at risk
EG0024 events4 affected261 at risk
EG003
Dyspnea
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0001 events1 affected218 at risk
EG0013 events2 affected90 at risk
EG00212 events11 affected261 at risk
EG003
Ear pain
Ear and labyrinth disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Edema face
General disorders
CTCv4
EG0000 events0 affected218 at risk
EG0012 events2 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Edema limbs
General disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Edema trunk
General disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Electrocardiogram QT corrected interval prolonged
Investigations
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Encephalitis infection
Infections and infestations
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Encephalomyelitis infection
Infections and infestations
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Encephalopathy
Nervous system disorders
CTCv4
EG0002 events2 affected218 at risk
EG0015 events4 affected90 at risk
EG0027 events7 affected261 at risk
EG003
Endocarditis infective
Infections and infestations
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Endocrine disorders - Other, specify
Endocrine disorders
CTCv4
EG0001 events1 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Enterocolitis
Gastrointestinal disorders
CTCv4
EG0004 events3 affected218 at risk
EG0010 events0 affected90 at risk
EG0023 events3 affected261 at risk
EG003
Enterocolitis infectious
Infections and infestations
CTCv4
EG00012 events9 affected218 at risk
EG0018 events5 affected90 at risk
EG00219 events17 affected261 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0001 events1 affected218 at risk
EG0012 events2 affected90 at risk
EG00212 events12 affected261 at risk
EG003
Erythema multiforme
Skin and subcutaneous tissue disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Esophageal hemorrhage
Gastrointestinal disorders
CTCv4
EG0001 events1 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Esophageal infection
Infections and infestations
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Esophageal pain
Gastrointestinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Esophageal ulcer
Gastrointestinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Esophagitis
Gastrointestinal disorders
CTCv4
EG0001 events1 affected218 at risk
EG0013 events3 affected90 at risk
EG0029 events9 affected261 at risk
EG003
Euphoria
Psychiatric disorders
CTCv4
EG0001 events1 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
External ear inflammation
Ear and labyrinth disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0023 events1 affected261 at risk
EG003
Extraocular muscle paresis
Eye disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Extrapyramidal disorder
Nervous system disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Eye disorders - Other, specify
Eye disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Eye infection
Infections and infestations
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Eye pain
Eye disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Facial muscle weakness
Nervous system disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Facial nerve disorder
Nervous system disorders
CTCv4
EG0000 events0 affected218 at risk
EG0012 events2 affected90 at risk
EG0023 events3 affected261 at risk
EG003
Facial pain
General disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Fall
Injury, poisoning and procedural complications
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Fatigue
General disorders
CTCv4
EG0000 events0 affected218 at risk
EG0015 events4 affected90 at risk
EG0029 events7 affected261 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
CTCv4
EG000387 events164 affected218 at risk
EG001124 events52 affected90 at risk
EG002279 events141 affected261 at risk
EG003
Fecal incontinence
Gastrointestinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Female genital tract fistula
Reproductive system and breast disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Fever
General disorders
CTCv4
EG00034 events26 affected218 at risk
EG0014 events3 affected90 at risk
EG00217 events16 affected261 at risk
EG003
Fibrinogen decreased
Investigations
CTCv4
EG00012 events7 affected218 at risk
EG0018 events7 affected90 at risk
EG00222 events20 affected261 at risk
EG003
Flashing lights
Eye disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Flu like symptoms
General disorders
CTCv4
EG0002 events2 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Fracture
Injury, poisoning and procedural complications
CTCv4
EG0001 events1 affected218 at risk
EG0012 events2 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Gait disturbance
General disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Gallbladder obstruction
Hepatobiliary disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Gallbladder pain
Hepatobiliary disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Gastritis
Gastrointestinal disorders
CTCv4
EG0001 events1 affected218 at risk
EG0012 events2 affected90 at risk
EG0022 events2 affected261 at risk
EG003
Gastrointestinal disorders - Other, specify
Gastrointestinal disorders
CTCv4
EG0005 events5 affected218 at risk
EG0012 events2 affected90 at risk
EG0023 events3 affected261 at risk
EG003
Gastroparesis
Gastrointestinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected261 at risk
EG003
General disorders and administration site conditions - Other, specify
General disorders
CTCv4
EG0003 events3 affected218 at risk
EG0015 events2 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Generalized muscle weakness
Musculoskeletal and connective tissue disorders
CTCv4
EG0001 events1 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
GGT increased
Investigations
CTCv4
EG00010 events5 affected218 at risk
EG0017 events6 affected90 at risk
EG00216 events10 affected261 at risk
EG003
Gingival pain
Gastrointestinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Glossopharyngeal nerve disorder
Nervous system disorders
CTCv4
EG0000 events0 affected218 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Glucose intolerance
Metabolism and nutrition disorders
CTCv4
EG0001 events1 affected218 at risk
EG0019 events6 affected90 at risk
EG0029 events8 affected261 at risk
EG003
Gum infection
Infections and infestations
CTCv4
EG0001 events1 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Gynecomastia
Reproductive system and breast disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Hallucinations
Psychiatric disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Headache
Nervous system disorders
CTCv4
EG0004 events3 affected218 at risk
EG00117 events11 affected90 at risk
EG00245 events34 affected261 at risk
EG003
Hearing impaired
Ear and labyrinth disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Hematoma
Vascular disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0022 events2 affected261 at risk
EG003
Hematuria
Renal and urinary disorders
CTCv4
EG0001 events1 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Hemoglobin increased
Investigations
CTCv4
EG0002 events2 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Hemolysis
Blood and lymphatic system disorders
CTCv4
EG0001 events1 affected218 at risk
EG0010 events0 affected90 at risk
EG0024 events4 affected261 at risk
EG003
Hemolytic uremic syndrome
Blood and lymphatic system disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Hemorrhoids
Gastrointestinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Hepatic failure
Hepatobiliary disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Hepatic hemorrhage
Hepatobiliary disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Hepatic infection
Infections and infestations
CTCv4
EG0002 events2 affected218 at risk
EG0011 events1 affected90 at risk
EG0022 events2 affected261 at risk
EG003
Hepatic necrosis
Hepatobiliary disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Hepatic pain
Hepatobiliary disorders
CTCv4
EG0000 events0 affected218 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Hepatitis viral
Infections and infestations
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Hepatobiliary disorders - Other, specify
Hepatobiliary disorders
CTCv4
EG0000 events0 affected218 at risk
EG0011 events1 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0011 events1 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Hydrocephalus
Nervous system disorders
CTCv4
EG0000 events0 affected218 at risk
EG0012 events2 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Hypercalcemia
Metabolism and nutrition disorders
CTCv4
EG0000 events0 affected218 at risk
EG0012 events2 affected90 at risk
EG0026 events6 affected261 at risk
EG003
Hyperglycemia
Metabolism and nutrition disorders
CTCv4
EG00028 events28 affected218 at risk
EG00133 events20 affected90 at risk
EG002126 events84 affected261 at risk
EG003
Hyperkalemia
Metabolism and nutrition disorders
CTCv4
EG0005 events5 affected218 at risk
EG0018 events8 affected90 at risk
EG00213 events13 affected261 at risk
EG003
Hypermagnesemia
Metabolism and nutrition disorders
CTCv4
EG0002 events2 affected218 at risk
EG0011 events1 affected90 at risk
EG0028 events8 affected261 at risk
EG003
Hypernatremia
Metabolism and nutrition disorders
CTCv4
EG0000 events0 affected218 at risk
EG0015 events4 affected90 at risk
EG0024 events4 affected261 at risk
EG003
Hypersomnia
Nervous system disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Hypertension
Vascular disorders
CTCv4
EG0007 events7 affected218 at risk
EG0013 events3 affected90 at risk
EG00217 events10 affected261 at risk
EG003
Hypertriglyceridemia
Metabolism and nutrition disorders
CTCv4
EG0001 events1 affected218 at risk
EG0016 events4 affected90 at risk
EG00214 events10 affected261 at risk
EG003
Hyperuricemia
Metabolism and nutrition disorders
CTCv4
EG0002 events2 affected218 at risk
EG0012 events2 affected90 at risk
EG0024 events3 affected261 at risk
EG003
Hypoalbuminemia
Metabolism and nutrition disorders
CTCv4
EG00025 events19 affected218 at risk
EG00112 events10 affected90 at risk
EG00233 events24 affected261 at risk
EG003
Hypocalcemia
Metabolism and nutrition disorders
CTCv4
EG00023 events21 affected218 at risk
EG00115 events14 affected90 at risk
EG00231 events26 affected261 at risk
EG003
Hypoglossal nerve disorder
Nervous system disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Hypoglycemia
Metabolism and nutrition disorders
CTCv4
EG00010 events8 affected218 at risk
EG0013 events3 affected90 at risk
EG0024 events4 affected261 at risk
EG003
Hypokalemia
Metabolism and nutrition disorders
CTCv4
EG00043 events30 affected218 at risk
EG00160 events33 affected90 at risk
EG00268 events49 affected261 at risk
EG003
Hypomagnesemia
Metabolism and nutrition disorders
CTCv4
EG0001 events1 affected218 at risk
EG0012 events2 affected90 at risk
EG0023 events3 affected261 at risk
EG003
Hyponatremia
Metabolism and nutrition disorders
CTCv4
EG00036 events34 affected218 at risk
EG00127 events22 affected90 at risk
EG00254 events46 affected261 at risk
EG003
Hypophosphatemia
Metabolism and nutrition disorders
CTCv4
EG0006 events6 affected218 at risk
EG0019 events8 affected90 at risk
EG00220 events15 affected261 at risk
EG003
Hypotension
Vascular disorders
CTCv4
EG0006 events5 affected218 at risk
EG0016 events6 affected90 at risk
EG00216 events16 affected261 at risk
EG003
Hypothermia
General disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
CTCv4
EG00012 events12 affected218 at risk
EG00114 events14 affected90 at risk
EG00226 events20 affected261 at risk
EG003
Ileal obstruction
Gastrointestinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Ileal perforation
Gastrointestinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Ileus
Gastrointestinal disorders
CTCv4
EG0002 events2 affected218 at risk
EG0015 events5 affected90 at risk
EG0028 events8 affected261 at risk
EG003
Immune system disorders - Other, specify
Immune system disorders
CTCv4
EG0002 events2 affected218 at risk
EG0010 events0 affected90 at risk
EG0022 events2 affected261 at risk
EG003
Infections and infestations - Other, specify
Infections and infestations
CTCv4
EG000347 events147 affected218 at risk
EG001179 events63 affected90 at risk
EG002322 events149 affected261 at risk
EG003
Infective myositis
Infections and infestations
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Infusion related reaction
General disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Injection site reaction
General disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Injury, poisoning and procedural complications - Other, specify
Injury, poisoning and procedural complications
CTCv4
EG0000 events0 affected218 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected261 at risk
EG003
INR increased
Investigations
CTCv4
EG0000 events0 affected218 at risk
EG0011 events1 affected90 at risk
EG00210 events6 affected261 at risk
EG003
Insomnia
Psychiatric disorders
CTCv4
EG0001 events1 affected218 at risk
EG0013 events2 affected90 at risk
EG0024 events3 affected261 at risk
EG003
Intra-abdominal hemorrhage
Gastrointestinal disorders
CTCv4
EG0001 events1 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Intracranial hemorrhage
Nervous system disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0022 events2 affected261 at risk
EG003
Intraoperative respiratory injury
Injury, poisoning and procedural complications
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Intraoperative skin injury
Injury, poisoning and procedural complications
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Investigations - Other, specify
Investigations
CTCv4
EG0003 events3 affected218 at risk
EG0012 events2 affected90 at risk
EG0022 events2 affected261 at risk
EG003
Iron overload
Metabolism and nutrition disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0023 events2 affected261 at risk
EG003
Irritability
General disorders
CTCv4
EG0003 events3 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Jejunal perforation
Gastrointestinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Joint effusion
Musculoskeletal and connective tissue disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Joint infection
Infections and infestations
CTCv4
EG0001 events1 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Joint range of motion decreased
Musculoskeletal and connective tissue disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Joint range of motion decreased lumbar spine
Musculoskeletal and connective tissue disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Kidney infection
Infections and infestations
CTCv4
EG0001 events1 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Laryngeal edema
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0003 events3 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Laryngeal mucositis
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Left ventricular systolic dysfunction
Cardiac disorders
CTCv4
EG0000 events0 affected218 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
CTCv4
EG0001 events1 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Leukoencephalopathy
Nervous system disorders
CTCv4
EG0001 events1 affected218 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Lip infection
Infections and infestations
CTCv4
EG0001 events1 affected218 at risk
EG0012 events1 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Lip pain
Gastrointestinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Lipase increased
Investigations
CTCv4
EG0008 events8 affected218 at risk
EG0018 events7 affected90 at risk
EG00269 events39 affected261 at risk
EG003
Lower gastrointestinal hemorrhage
Gastrointestinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Lung infection
Infections and infestations
CTCv4
EG00037 events29 affected218 at risk
EG0015 events5 affected90 at risk
EG00223 events21 affected261 at risk
EG003
Lymph gland infection
Infections and infestations
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Lymphedema
Vascular disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Lymphocyte count decreased
Investigations
CTCv4
EG00038 events15 affected218 at risk
EG00129 events9 affected90 at risk
EG00232 events14 affected261 at risk
EG003
Malabsorption
Gastrointestinal disorders
CTCv4
EG0001 events1 affected218 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Memory impairment
Nervous system disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Meningitis
Infections and infestations
CTCv4
EG0001 events1 affected218 at risk
EG0012 events1 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Middle ear inflammation
Ear and labyrinth disorders
CTCv4
EG0002 events2 affected218 at risk
EG0012 events1 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Mucosal infection
Infections and infestations
CTCv4
EG0002 events2 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Mucositis oral
Gastrointestinal disorders
CTCv4
EG00028 events22 affected218 at risk
EG00124 events19 affected90 at risk
EG00263 events57 affected261 at risk
EG003
Multi-organ failure
General disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Muscle weakness left-sided
Musculoskeletal and connective tissue disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Muscle weakness lower limb
Musculoskeletal and connective tissue disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0023 events3 affected261 at risk
EG003
Muscle weakness right-sided
Musculoskeletal and connective tissue disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Muscle weakness upper limb
Musculoskeletal and connective tissue disorders
CTCv4
EG0000 events0 affected218 at risk
EG0011 events1 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Musculoskeletal and connective tissue disorder - Other, specify
Musculoskeletal and connective tissue disorders
CTCv4
EG0001 events1 affected218 at risk
EG0010 events0 affected90 at risk
EG0022 events2 affected261 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
CTCv4
EG0000 events0 affected218 at risk
EG0011 events1 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Myelitis
Nervous system disorders
CTCv4
EG0000 events0 affected218 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Myocardial infarction
Cardiac disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Myositis
Musculoskeletal and connective tissue disorders
CTCv4
EG0000 events0 affected218 at risk
EG0011 events1 affected90 at risk
EG0023 events3 affected261 at risk
EG003
Nail infection
Infections and infestations
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0022 events1 affected261 at risk
EG003
Nausea
Gastrointestinal disorders
CTCv4
EG0008 events8 affected218 at risk
EG0017 events5 affected90 at risk
EG00229 events26 affected261 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
CTCv4
EG0001 events1 affected218 at risk
EG0011 events1 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Neck soft tissue necrosis
Musculoskeletal and connective tissue disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Nervous system disorders - Other, specify
Nervous system disorders
CTCv4
EG0003 events3 affected218 at risk
EG0011 events1 affected90 at risk
EG0027 events7 affected261 at risk
EG003
Neuralgia
Nervous system disorders
CTCv4
EG0004 events4 affected218 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Neutrophil count decreased
Investigations
CTCv4
EG000682 events184 affected218 at risk
EG001248 events61 affected90 at risk
EG002585 events187 affected261 at risk
EG003
Non-cardiac chest pain
General disorders
CTCv4
EG0001 events1 affected218 at risk
EG0011 events1 affected90 at risk
EG0024 events4 affected261 at risk
EG003
Nystagmus
Nervous system disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Obesity
Metabolism and nutrition disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Oculomotor nerve disorder
Nervous system disorders
CTCv4
EG0000 events0 affected218 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Optic nerve disorder
Eye disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Oral hemorrhage
Gastrointestinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Oral pain
Gastrointestinal disorders
CTCv4
EG0002 events2 affected218 at risk
EG0015 events5 affected90 at risk
EG00212 events11 affected261 at risk
EG003
Osteoporosis
Musculoskeletal and connective tissue disorders
CTCv4
EG0000 events0 affected218 at risk
EG0011 events1 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Otitis externa
Infections and infestations
CTCv4
EG0003 events3 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Otitis media
Infections and infestations
CTCv4
EG00018 events16 affected218 at risk
EG0013 events3 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Pain
General disorders
CTCv4
EG0002 events2 affected218 at risk
EG0017 events6 affected90 at risk
EG00211 events10 affected261 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
CTCv4
EG0004 events4 affected218 at risk
EG0017 events5 affected90 at risk
EG00215 events13 affected261 at risk
EG003
Pain of skin
Skin and subcutaneous tissue disorders
CTCv4
EG0001 events1 affected218 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Palmar-plantar erythrodysesthesia syndrome
Skin and subcutaneous tissue disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Pancreas infection
Infections and infestations
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0022 events2 affected261 at risk
EG003
Pancreatic anastomotic leak
Injury, poisoning and procedural complications
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Pancreatic hemorrhage
Gastrointestinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Pancreatic necrosis
Gastrointestinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Pancreatitis
Gastrointestinal disorders
CTCv4
EG0004 events3 affected218 at risk
EG0016 events5 affected90 at risk
EG00221 events16 affected261 at risk
EG003
Papilledema
Eye disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Paresthesia
Nervous system disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Paronychia
Infections and infestations
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Paroxysmal atrial tachycardia
Cardiac disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Pelvic floor muscle weakness
Reproductive system and breast disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Pelvic infection
Infections and infestations
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Penile infection
Infections and infestations
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Penile pain
Reproductive system and breast disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Pericardial effusion
Cardiac disorders
CTCv4
EG0002 events2 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Perineal pain
Reproductive system and breast disorders
CTCv4
EG0001 events1 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Periorbital edema
Skin and subcutaneous tissue disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Peripheral motor neuropathy
Nervous system disorders
CTCv4
EG00021 events12 affected218 at risk
EG00114 events12 affected90 at risk
EG00267 events34 affected261 at risk
EG003
Peripheral nerve infection
Infections and infestations
CTCv4
EG0000 events0 affected218 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
CTCv4
EG00020 events11 affected218 at risk
EG00110 events7 affected90 at risk
EG00227 events22 affected261 at risk
EG003
Peritoneal infection
Infections and infestations
CTCv4
EG0000 events0 affected218 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Personality change
Psychiatric disorders
CTCv4
EG0001 events1 affected218 at risk
EG0011 events1 affected90 at risk
EG0025 events5 affected261 at risk
EG003
Pharyngeal mucositis
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0001 events1 affected218 at risk
EG0010 events0 affected90 at risk
EG0022 events2 affected261 at risk
EG003
Pharyngeal stenosis
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Pharyngitis
Infections and infestations
CTCv4
EG0004 events3 affected218 at risk
EG0010 events0 affected90 at risk
EG0022 events2 affected261 at risk
EG003
Pharyngolaryngeal pain
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0022 events2 affected261 at risk
EG003
Phlebitis infective
Infections and infestations
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Photophobia
Eye disorders
CTCv4
EG0000 events0 affected218 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Photosensitivity
Skin and subcutaneous tissue disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Platelet count decreased
Investigations
CTCv4
EG000199 events96 affected218 at risk
EG00185 events39 affected90 at risk
EG002217 events101 affected261 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0002 events2 affected218 at risk
EG0014 events4 affected90 at risk
EG0025 events5 affected261 at risk
EG003
Pleural hemorrhage
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0007 events7 affected218 at risk
EG0015 events5 affected90 at risk
EG0029 events9 affected261 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0022 events2 affected261 at risk
EG003
Portal hypertension
Hepatobiliary disorders
CTCv4
EG0001 events1 affected218 at risk
EG0011 events1 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Postoperative hemorrhage
Injury, poisoning and procedural complications
CTCv4
EG0000 events0 affected218 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Postoperative thoracic procedure complication
Injury, poisoning and procedural complications
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Proctitis
Gastrointestinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0022 events2 affected261 at risk
EG003
Proteinuria
Renal and urinary disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0022 events2 affected261 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
CTCv4
EG0000 events0 affected218 at risk
EG0012 events2 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Psychiatric disorders - Other, specify
Psychiatric disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Psychosis
Psychiatric disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0024 events3 affected261 at risk
EG003
Purpura
Skin and subcutaneous tissue disorders
CTCv4
EG0002 events1 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Pyramidal tract syndrome
Nervous system disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Radiation recall reaction (dermatologic)
Injury, poisoning and procedural complications
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
CTCv4
EG0001 events1 affected218 at risk
EG0014 events4 affected90 at risk
EG0027 events7 affected261 at risk
EG003
Rash pustular
Infections and infestations
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Rectal hemorrhage
Gastrointestinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Rectal mucositis
Gastrointestinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Rectal pain
Gastrointestinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0022 events2 affected261 at risk
EG003
Rectal ulcer
Gastrointestinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0023 events1 affected261 at risk
EG003
Renal and urinary disorders - Other, specify
Renal and urinary disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Renal calculi
Renal and urinary disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Renal colic
Renal and urinary disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Reproductive system and breast disorders - Other, specify
Reproductive system and breast disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Respiratory, thoracic and mediastinal disorders - Other, specify
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0002 events2 affected218 at risk
EG0012 events2 affected90 at risk
EG0023 events3 affected261 at risk
EG003
Restrictive cardiomyopathy
Cardiac disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Retinal detachment
Eye disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Rhinitis infective
Infections and infestations
CTCv4
EG0001 events1 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Salivary gland infection
Infections and infestations
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Seizure
Nervous system disorders
CTCv4
EG0003 events3 affected218 at risk
EG0013 events3 affected90 at risk
EG00210 events9 affected261 at risk
EG003
Sepsis
Infections and infestations
CTCv4
EG0002 events2 affected218 at risk
EG0015 events3 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Serum amylase increased
Investigations
CTCv4
EG0004 events4 affected218 at risk
EG0015 events4 affected90 at risk
EG00232 events17 affected261 at risk
EG003
Sinus bradycardia
Cardiac disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Sinus disorder
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Sinus tachycardia
Cardiac disorders
CTCv4
EG0002 events2 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Sinusitis
Infections and infestations
CTCv4
EG0006 events6 affected218 at risk
EG00110 events6 affected90 at risk
EG00210 events9 affected261 at risk
EG003
Skin and subcutaneous tissue disorders - Other, specify
Skin and subcutaneous tissue disorders
CTCv4
EG0001 events1 affected218 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Skin infection
Infections and infestations
CTCv4
EG00011 events9 affected218 at risk
EG0019 events8 affected90 at risk
EG00214 events13 affected261 at risk
EG003
Skin ulceration
Skin and subcutaneous tissue disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0022 events2 affected261 at risk
EG003
Small intestinal mucositis
Gastrointestinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0012 events1 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Small intestinal perforation
Gastrointestinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Small intestine infection
Infections and infestations
CTCv4
EG0003 events1 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Soft tissue infection
Infections and infestations
CTCv4
EG0001 events1 affected218 at risk
EG0013 events2 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Soft tissue necrosis upper limb
Musculoskeletal and connective tissue disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Sore throat
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Spleen disorder
Blood and lymphatic system disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Splenic infection
Infections and infestations
CTCv4
EG0001 events1 affected218 at risk
EG0011 events1 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Stevens-Johnson syndrome
Skin and subcutaneous tissue disorders
CTCv4
EG0000 events0 affected218 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Stoma site infection
Infections and infestations
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Stomach pain
Gastrointestinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0011 events1 affected90 at risk
EG0023 events3 affected261 at risk
EG003
Stroke
Nervous system disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Suicidal ideation
Psychiatric disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Suicide attempt
Psychiatric disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Surgical and medical procedures - Other, specify
Surgical and medical procedures
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Syncope
Nervous system disorders
CTCv4
EG0001 events1 affected218 at risk
EG0013 events2 affected90 at risk
EG0028 events7 affected261 at risk
EG003
Testicular pain
Reproductive system and breast disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Thromboembolic event
Vascular disorders
CTCv4
EG0001 events1 affected218 at risk
EG0011 events1 affected90 at risk
EG0029 events8 affected261 at risk
EG003
Thrombotic thrombocytopenic purpura
Blood and lymphatic system disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Tooth infection
Infections and infestations
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Toothache
Gastrointestinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0011 events1 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Tracheal mucositis
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Tracheitis
Infections and infestations
CTCv4
EG0000 events0 affected218 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Treatment related secondary malignancy
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Tremor
Nervous system disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Trigeminal nerve disorder
Nervous system disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Trismus
Musculoskeletal and connective tissue disorders
CTCv4
EG0000 events0 affected218 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Tumor lysis syndrome
Metabolism and nutrition disorders
CTCv4
EG0001 events1 affected218 at risk
EG0012 events2 affected90 at risk
EG0028 events8 affected261 at risk
EG003
Typhlitis
Gastrointestinal disorders
CTCv4
EG0005 events5 affected218 at risk
EG0015 events5 affected90 at risk
EG00211 events10 affected261 at risk
EG003
Upper gastrointestinal hemorrhage
Gastrointestinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Upper respiratory infection
Infections and infestations
CTCv4
EG00038 events28 affected218 at risk
EG0018 events5 affected90 at risk
EG00215 events14 affected261 at risk
EG003
Urethral infection
Infections and infestations
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Urinary incontinence
Renal and urinary disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Urinary retention
Renal and urinary disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Urinary tract infection
Infections and infestations
CTCv4
EG0008 events7 affected218 at risk
EG0017 events5 affected90 at risk
EG0029 events8 affected261 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
CTCv4
EG0001 events1 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Urinary tract pain
Renal and urinary disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Urine output decreased
Investigations
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
CTCv4
EG0000 events0 affected218 at risk
EG0011 events1 affected90 at risk
EG0025 events5 affected261 at risk
EG003
Uterine hemorrhage
Reproductive system and breast disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Vaginal hemorrhage
Reproductive system and breast disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Vaginal infection
Infections and infestations
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Vaginal pain
Reproductive system and breast disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Vagus nerve disorder
Nervous system disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Vascular access complication
Injury, poisoning and procedural complications
CTCv4
EG0000 events0 affected218 at risk
EG0015 events4 affected90 at risk
EG0026 events6 affected261 at risk
EG003
Vascular disorders - Other, specify
Vascular disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0025 events5 affected261 at risk
EG003
Vasculitis
Vascular disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0022 events1 affected261 at risk
EG003
Vasovagal reaction
Nervous system disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Ventricular arrhythmia
Cardiac disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Ventricular fibrillation
Cardiac disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Ventricular tachycardia
Cardiac disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Vitreous hemorrhage
Eye disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected261 at risk
EG003
Voice alteration
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Vomiting
Gastrointestinal disorders
CTCv4
EG00016 events16 affected218 at risk
EG00113 events11 affected90 at risk
EG00247 events40 affected261 at risk
EG003
Weight gain
Investigations
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0023 events3 affected261 at risk
EG003
Weight loss
Investigations
CTCv4
EG00013 events11 affected218 at risk
EG0013 events3 affected90 at risk
EG00219 events17 affected261 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0000 events0 affected218 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected261 at risk
EG003
White blood cell decreased
Investigations
CTCv4
EG000292 events91 affected218 at risk
EG001125 events41 affected90 at risk
EG002307 events103 affected261 at risk
EG003
Wound dehiscence
Injury, poisoning and procedural complications
CTCv4
EG0000 events0 affected218 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected261 at risk
EG003
Wound infection
Infections and infestations
CTCv4
EG0001 events1 affected218 at risk
EG0013 events3 affected90 at risk
EG0021 events1 affected261 at risk
EG003
The COG SDC reviewed the NLM notification related to ct.gov AE/SAE reporting. The information in 'Additional Description' is accurate with respect to data supplied to ct.gov.COG plans to submit data AE/SAE data consistent with the text in this field.
Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old
Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
OG003
Dexamethasone, High Dose Methotrexate (IM) < 10 Years
Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
OG004
Prednisone, Capizzi Methotrexate <10 Years
Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
OG005
Prednisone, Capizzi Methotrexate >= 10 Years
Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
OG006
Predisone and High Dose Methotrexate < 10 Yrs Old
Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
OG007
Prednisone and High Dose Methotrexate >=10 Years
Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
OG008
Dexamethasone, High Dose Methotrexate (IM) >= 10 Years
Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
Units
Counts
Participants
OG00028
OG00113
OG00253
OG00315
OG00417
OG005116
OG00620
OG007112
OG00844
Title
Denominators
Categories
Title
Measurements
OG00079.2(59.5 to 98.8)
OG00169.9(32.4 to 100)
OG00265.6(50.2 to 81.0)
OG00386.2(49.9 to 100)
OG00493.8(70.8 to 100)
OG00563.1(49.4 to 76.8)
OG00684.2(66.53 to 100)
OG00773.6(59.8 to 87.4)
OG00874.6(60.9 to 88.3)
OG002
Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old
Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
OG003
Dexamethasone, High Dose Methotrexate (IM) < 10 Years
Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
OG004
Prednisone, Capizzi Methotrexate <10 Years
Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
OG005
Prednisone, Capizzi Methotrexate >= 10 Years
Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
OG006
Prednisone and High Dose Methotrexate < 10 Yrs Old
Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
OG007
Prednisone and High Dose Methotrexate >=10 Years
Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
OG008
Dexamethasone, High Dose Methotrexate (IM) >= 10 Years
Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
OG010
Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random)
Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
Units
Counts
Participants
OG000185
OG00173
OG002198
OG003189
OG004195
OG005472
OG006191
OG007480
OG008209
OG00925
OG0104
Title
Denominators
Categories
Title
Measurements
OG00095.4(91.3 to 99.4)
OG00192.9(85.4 to 100)
OG00287.4(82.5 to 92.4)
OG00398.1(95.4 to 100)
OG00493.3(88.6 to 98.0)
OG00590.2(85.5 to 94.9)
OG00694.5(90.0 to 98.9)
OG00790.5(86.1 to 95.0)
OG00891.6(87.5 to 95.8)
OG00978.3(61.0 to 95.7)
OG01025.0(-17.4 to 67.4)
OG002
Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old
Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
OG003
Dexamethasone, High Dose Methotrexate (IM) < 10 Years
Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
OG004
Prednisone, Capizzi Methotrexate <10 Years
Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
OG005
Prednisone, Capezzi Methotrexate >= 10 Years
Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
OG006
Prednisone and High Dose Methotrexate < 10 Yrs Old
Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
OG007
Prednisone and High Dose Methotrexate >=10 Years
Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
OG008
Dexamethasone, High Dose Methotrexate (IM) >= 10 Years
Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
OG010
Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random)
Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
OG011
Prednisone and High Dose Methotrexate (Non Randomly Assigned)
Patients non-randomly assigned to the PH regimen based on one (or more) of the following: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal MTX in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
Units
Counts
Participants
OG00028
OG00113
OG00253
OG00315
OG00417
OG005116
OG00620
OG007112
OG00844
OG0093
OG0103
OG0115
Title
Denominators
Categories
Title
Measurements
OG00026
OG00112
OG00243
OG00314
OG00416
OG00595
OG00617
OG00798
OG00839
OG0093
OG0103
OG0113
OG002
Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old
Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
OG003
Dexamethasone, High Dose Methotrexate (IM) < 10 Years
Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
OG004
Prednisone, Capizzi Methotrexate <10 Years
Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
OG005
Prednisone, Capezzi Methotrexate >= 10 Years
Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
OG006
Prednisone and High Dose Methotrexate < 10 Yrs Old
Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
OG007
Prednisone and High Dose Methotrexate >=10 Years
Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
OG008
Dexamethasone, High Dose Methotrexate (IM) >= 10 Years
Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
OG010
Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random)
Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
OG011
Prednisone and High Dose Methotrexate (Non Randomly Assigned)
Patients non-randomly assigned to the PH regimen based on one (or more) of the following: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal MTX in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
Units
Counts
Participants
OG000185
OG00173
OG002198
OG003189
OG004195
OG005472
OG006191
OG007480
OG008209
OG00925
OG0104
OG01118
Title
Denominators
Categories
Title
Measurements
OG000182
OG00172
OG002198
OG003188
OG004195
OG005471
OG006190
OG007479
OG008208
OG00925
OG0103
OG01118
OG002
Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old
Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
OG003
Dexamethasone, High Dose Methotrexate (IM) < 10 Years
Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
OG004
Prednisone, Capizzi Methotrexate <10 Years
Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
OG005
Prednisone, Capizzi Methotrexate >= 10 Years
Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
OG006
Prednisone and High Dose Methotrexate < 10 Yrs Old
Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
OG007
Prednisone and High Dose Methotrexate >=10 Years
Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
OG008
Dexamethasone, High Dose Methotrexate (IM) >= 10 Years
Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
Units
Counts
Participants
OG00028
OG00113
OG00253
OG00315
OG00417
OG005116
OG00620
OG007112
OG00844
Title
Denominators
Categories
Title
Measurements
OG00066.5(43.7 to 89.2)
OG00143.3(6.4 to 80.2)
OG00235.4(21.4 to 49.3)
OG00380(30.4 to 100)
OG00434.7(-4.2 to 73.5)
OG00539(25.7 to 52.4)
OG00655(29.4 to 80.6)
OG00747.8(32.3 to 63.3)
OG00849.4(34.0 to 64.8)
OG002
Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old
Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
OG003
Dexamethasone, High Dose Methotrexate (IM) < 10 Years
Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
OG004
Prednisone, Capizzi Methotrexate <10 Years
Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
OG005
Prednisone, Capezzi Methotrexate >= 10 Years
Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
OG006
Prednisone and High Dose Methotrexate < 10 Yrs Old
Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
OG007
Prednisone and High Dose Methotrexate >=10 Years
Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
OG008
Dexamethasone, High Dose Methotrexate (IM) >= 10 Years
Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
OG010
Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random)
Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).