Risk-Adapted Chemotherapy in Treating Younger Patients With Newly Diagnosed Standard-Risk Acute Lymphoblastic Leukemia or Localized B-Lineage Lymphoblastic Lymphoma
Official Title
Treatment of Patients With Newly Diagnosed Standard Risk B-Lymphoblastic Leukemia (B-ALL) or Localized B-Lineage Lymphoblastic Lymphoma (B-LLy)
Acronym
Not provided
Organization
Children's Oncology GroupNETWORK
Status Module
Record Verification Date
May 2026
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
Aug 11, 2010Actual
Primary Completion Date
Mar 31, 2019Actual
Completion Date
Mar 31, 2026Actual
First Submitted Date
Aug 27, 2010
First Submission Date that Met QC Criteria
Aug 27, 2010
First Posted Date
Aug 30, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 25, 2020
Results First Submitted that Met QC Criteria
Jun 5, 2020
Results First Posted Date
Jun 23, 2020Actual
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
May 26, 2026
Last Update Posted Date
May 28, 2026Actual
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
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This partially randomized phase III trial studies the side effects of different combinations of risk-adapted chemotherapy regimens and how well they work in treating younger patients with newly diagnosed standard-risk acute lymphoblastic leukemia or B-lineage lymphoblastic lymphoma that is found only in the tissue or organ where it began (localized). Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy), giving the drugs in different doses, and giving the drugs in different combinations may kill more cancer cells.
Detailed Description
PRIMARY OBJECTIVES:
l. To determine if a maintenance regimen containing weekly oral methotrexate at 40 mg/m^2/week will result in an improved disease free survival (DFS) compared to that containing weekly oral methotrexate at 20 mg/m^2/week in the average-risk (AR) subset of patients with standard-risk B-precursor acute lymphoblastic leukemia (ALL). (Complete effective January 13, 2017) II. To determine whether a reduced-pulses maintenance regimen with vincristine (vincristine sulfate)/dexamethasone pulses delivered every 12 weeks can be used without adversely impacting DFS as compared to pulses given every 4 weeks in the AR subset of patients with standard risk B-precursor ALL.
III. To confirm that patients in the low-risk (LR) subset of standard risk B-precursor ALL, based on clinical and cytogenetic features and minimal residual disease (MRD) criteria, can attain a 5 year DFS of at least 95% with either a P9904 based regimen that includes 6 courses of intermediate dose (1 g/m^2 over 24 hours) methotrexate without alkylating agents or anthracyclines (Arm LR-M), or an outpatient based regimen identical to that of AR patients with reduced vincristine/dexamethasone pulses at 12 week intervals during maintenance (Arm LR-C).
IV. To provide standardized treatment and enhanced supportive care to children with standard-risk (SR) Down syndrome B-ALL in order to improve outcomes and facilitate further study of this biologically and clinically unique patient subgroup.
V. To improve understanding of the biology of localized B-lineage lymphoblastic lymphoma (B-LLy) and Down syndrome (DS) B-LLy by obtaining biologic data, including fluorescence in situ hybridization (FISH) for recurrent cytogenetic lesions on paraffin specimen, and banking tissue for future research.
VI. To describe the 5-year event free survival (EFS) and overall survival (OS) of patients with Murphy stage I and II B-LLy receiving modified AR B-ALL therapy.
SECONDARY OBJECTIVES:
I. To assess the burden of AR B-ALL therapy as measured by surveys of the child's quality of life, missed days of school/daycare/work by children and parents, family functioning, parental perception of the child's health vulnerability, physical functioning, and emotional distress, 1) overall at different time points during and at the end of therapy, and by 2) comparing children randomized to every 4 week vs. every 12 week dexamethasone/vincristine pulses during maintenance. (Closed to accrual as of April 19, 2013) II. To characterize the onset, severity, and natural history of vincristine associated neuropathy by physical therapists (or occupational therapists) in children undergoing therapy for AR B-ALL, 1) overall at different time points during and at the end of therapy, and by 2) comparing children randomized to every 4 week vs. every 12 week dexamethasone/vincristine pulses during maintenance. (Closed to accrual as of March 15, 2013)
TERTIARY OBJECTIVES:
I. To explore the correlation of minimal marrow disease (MMD) at diagnosis and outcome for patients with B-LLy. (Closed effective Amendment #5)
OUTLINE:
All patients receive induction therapy comprising intrathecal (IT) cytarabine on day 1; vincristine sulfate IV on days 1, 8, 15, and 22; dexamethasone orally (PO) or IV twice daily (BID) on days 1-28; pegaspargase IV over 1-2 hours on day 4; and IT methotrexate* on days 8 and 29. Patients with Philadelphia chromosome-positive disease are eligible to transfer to COG-AALL0622 by day 15 of induction therapy and patients with high-risk (HR) or very high-risk (VHR) disease are eligible to transfer to a COG HR or VHR trial at the end of induction therapy. Patients with standard-risk disease with Down syndrome (DS) who have bone marrow minimal residual disease 0.01% are eligible to transfer to the DS stratum of the HR trial. Patients with induction failure (defined as M3 [> 25% lymphoblasts] on day 29) may be eligible for the COG VHR-acute lymphoblastic leukemia study.
NOTE: *Patients with DS also receive oral leucovorin calcium every 12 hours on days 10-11 and 31-32.
STANDARD-RISK WITH DOWN SYNDROME:
Consolidation therapy (4 weeks): Patients receive vincristine sulfate IV on day 1; mercaptopurine PO on days 1-28; IT methotrexate on days 1, 8, and 15; and leucovorin calcium PO every 12 hours on days 3-4, 10-11, and 17-18. Interim maintenance I therapy (8 weeks): Patients receive vincristine sulfate IV and methotrexate IV over 2-15 minutes on days 1, 11, 21, 31, and 41; IT methotrexate on day 31; and leucovorin calcium PO every 12 hours on days 36-34. Delayed-intensification therapy (8 weeks): Patients receive dexamethasone PO or IV BID on days 1-7 and 15-21; vincristine sulfate IV and doxorubicin hydrochloride IV over 1-15 minutes on days 1, 8, and 15; pegaspargase IV over 1-2 hours on day 4; cyclophosphamide IV over 30-60 minutes on day 29; thioguanine PO on days 29-42; cytarabine IV over 1-30 minutes or subcutaneously (SC) on days 29-32 and 33-39; IT methotrexate on days 1 and 29; and leucovorin calcium PO every 12 hours on days 3-4 and 31-32. Interim maintenance II therapy (8 weeks): Patients receive vincristine sulfate IV and methotrexate IV over 2-15 minutes on days 1, 11, 21, 31, and 41; IT methotrexate on days 1 and 31; and leucovorin calcium PO every 12 hours on days 3-4 and 33-34. Maintenance therapy: Patients receive vincristine sulfate IV on day 1; dexamethasone PO BID on days 1-5; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1. Courses repeat every 12 weeks for 2 years (timed from the start of interim maintenance I therapy).
B-LLy:
Consolidation therapy (4 weeks): Patients receive vincristine sulfate IV on day 1; mercaptopurine PO on days 1-28; IT methotrexate on days 1, 8, and 15; and leucovorin calcium PO every 12 hours on days 3-4, 10-11, and 17-18. Interim maintenance I therapy (8 weeks): Patients receive vincristine sulfate IV and methotrexate IV over 2-15 minutes on days 1, 11, 21, 31, and 41; IT methotrexate on day 31; and leucovorin calcium PO every 12 hours on days 36-34. Delayed-intensification therapy (8 weeks): Patients receive dexamethasone PO or IV BID on days 1-7 and 15-21; vincristine sulfate IV and doxorubicin hydrochloride IV over 1-15 minutes on days 1, 8, and 15; pegaspargase IV over 1-2 hours on day 4; cyclophosphamide IV over 30-60 minutes on day 29; thioguanine PO on days 29-42; cytarabine IV over 1-30 minutes or subcutaneously (SC) on days 29-32 and 33-39; IT methotrexate on days 1 and 29; and leucovorin calcium PO every 12 hours on days 3-4 and 31-32. Interim maintenance II therapy (8 weeks): Patients receive vincristine sulfate IV and methotrexate IV over 2-15 minutes on days 1, 11, 21, 31, and 41; IT methotrexate on days 1 and 31; and leucovorin calcium PO every 12 hours on days 3-4 and 33-34. Maintenance therapy: Patients receive vincristine sulfate IV on day 1; dexamethasone PO BID on days 1-5; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1. Courses repeat every 4 weeks for 2 years (timed from the start of interim maintenance I therapy).
AVERAGE-RISK:
Consolidation therapy (4 weeks): Patients receive vincristine sulfate IV on day 1; mercaptopurine PO on days 1-28; and IT methotrexate on days 1, 8, and 15.Interim maintenance I therapy (8 weeks): Patients receive vincristine sulfate IV and methotrexate IV over 2-15 minutes on days 1, 11, 21, 31, and 41 and IT methotrexate on day 31. Delayed intensification therapy (8 weeks): Patients receive dexamethasone PO or IV BID on days 1-7 and 15-21; vincristine sulfate IV and doxorubicin hydrochloride IV over 1-15 minutes on days 1, 8, and 15; pegaspargase IV over 1-2 hours on day 4; cyclophosphamide IV over 30-60 minutes on day 29; thioguanine PO on days 29-42; cytarabine IV over 1-30 minutes or SC on days 29-32 and 36-39; and IT methotrexate on days 1 and 29. Interim maintenance II therapy (8 weeks): Patients receive vincristine sulfate IV and methotrexate IV over 2-15 minutes on days 1, 11, 21, 31, and 41 and IT methotrexate on days 1 and 31. Maintenance therapy: Patients are randomized to 1 of 4 maintenance therapy treatment arms.
Arm A: Patients receive vincristine sulfate IV on days 1, 29, and 57; dexamethasone PO BID on days 1-5, 29-33, and 57-61; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.
Arm B: Patients receive vincristine sulfate IV on days 1, 29, and 57; dexamethasone PO BID on days 1-5, 29-33, and 57-61; higher-dose methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.
Arm C: Patients receive vincristine sulfate IV on day 1; dexamethasone PO BID on days 1-5; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.
Arm D: Patients receive vincristine sulfate IV on day 1; dexamethasone PO BID on days 1-5; higher-dose methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.
In all arms, maintenance therapy courses repeat every 12 weeks for 2 years for girls and for 3 years for boys (timed from the start of interim maintenance I therapy).
LOW-RISK: Patients are randomized to 1 of 2 treatment arms.
Arm I (LR-M): Consolidation therapy (19 weeks): Beginning one week after completion of induction therapy, patients receive vincristine sulfate IV on days 15, 22, 78, and 85; methotrexate IV over 24 hours and IT methotrexate on days 8, 29, 50, 71, 92, and 113; leucovorin calcium PO or IV on days 9-10, 30-31, 51-52, 72-73, 93-94, and 114-115; dexamethasone PO BID or IV on days 15-21 and 78-84; and PO mercaptopurine on days 1-133.Maintenance therapy: Patients receive vincristine sulfate IV on days 1 and 8; dexamethasone PO BID on days 1-7; methotrexate* PO on days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, and 106; and mercaptopurine PO on days 1-112. Courses repeat every 16 weeks. Patients also receive IT methotrexate on days 1 and 85 (courses 1 and 4), day 57 (courses 2 and 5), or day 29 (courses 3 and 6). Patients then receive course 7 comprising vincristine sulfate IV on days 1 and 8; dexamethasone PO BID on days 1-7; methotrexate PO on days 1, 8, 15, 22, 29, 36, 43, 50, 57, and 64; and mercaptopurine PO on days 1-70. Treatment continues for 2 and ½ years (timed from the date of diagnosis).NOTE: *Patients do not receive methotrexate PO on the days that they receive IT methotrexate.
Arm II (LR-C): Consolidation therapy (4 weeks): Patients receive vincristine sulfate IV on day 1; oral mercaptopurine on days 1-28; and IT methotrexate on days 1, 8, and 15. Interim maintenance I therapy (8 weeks): Patients receive vincristine sulfate IV and methotrexate IV over 2-15 minutes on days 1, 11, 21, 31, and 41 and IT methotrexate on day 31. Delayed-intensification therapy (8 weeks): Patients receive dexamethasone PO or IV BID on days 1-7 and 15-21; vincristine sulfate IV and doxorubicin hydrochloride IV over 1-15 minutes on days 1, 8, and 15; pegaspargase IV over 1-2 hours on day 4; cyclophosphamide IV over 30-60 minutes on day 29; thioguanine PO on days 29-42; cytarabine IV over 1-30 minutes or SC on days 29-32 and 36-39; and IT methotrexate on days 1 and 29.Interim maintenance II therapy (8 weeks): Patients receive vincristine sulfate IV and methotrexate IV over 2-15 minutes on days 1, 11, 21, 31, and 41 and IT methotrexate on days 1 and 31. Maintenance therapy: Patients receive vincristine sulfate IV on day 1; dexamethasone PO BID on days 1-5; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1. Courses repeat every 12 weeks for 2 years for girls and for 3 years for boys (timed from the start of interim maintenance I therapy).
After completion of study treatment, patients are followed up periodically for 10 years from study entry.
Conditions Module
Conditions
Acute Lymphoblastic Leukemia
Adult B Lymphoblastic Lymphoma
Ann Arbor Stage I B Lymphoblastic Lymphoma
Ann Arbor Stage II B Lymphoblastic Lymphoma
Childhood B Acute Lymphoblastic Leukemia
Childhood B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
Childhood B Lymphoblastic Lymphoma
Down Syndrome
Hypodiploid B Acute Lymphoblastic Leukemia
Philadelphia Chromosome Positive
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
9,350Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Arm A (risk-adapted chemotherapy)
Experimental
Patients receive vincristine sulfate IV on days 1, 29, and 57; dexamethasone PO BID on days 1-5, 29-33, and 57-61; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.
Drug: Dexamethasone
Other: Laboratory Biomarker Analysis
Drug: Mercaptopurine
Drug: Methotrexate
Other: Quality-of-Life Assessment
Other: Questionnaire Administration
Drug: Vincristine Sulfate
Arm B (risk-adapted chemotherapy)
Experimental
Patients receive vincristine sulfate IV on days 1, 29, and 57; dexamethasone PO BID on days 1-5, 29-33, and 57-61; higher-dose methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.
Drug: Dexamethasone
Other: Laboratory Biomarker Analysis
Drug: Mercaptopurine
Drug: Methotrexate
Other: Quality-of-Life Assessment
Other: Questionnaire Administration
Drug: Vincristine Sulfate
Arm B-LLy (4-week cycle maintenance)
Experimental
See Detailed Description.
Drug: Cyclophosphamide
Drug: Cytarabine
Drug: Dexamethasone
Drug: Doxorubicin Hydrochloride
Other: Laboratory Biomarker Analysis
Drug: Leucovorin Calcium
Drug: Mercaptopurine
Drug: Methotrexate
Drug: Pegaspargase
Other: Quality-of-Life Assessment
Other: Questionnaire Administration
Drug: Thioguanine
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Cyclophosphamide
Drug
Given IV
Arm B-LLy (4-week cycle maintenance)
Arm LR-C (risk-adapted chemotherapy)
Arm SR DS (12-week cycle maintenance)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Disease Free Survival (DFS) in Average Risk (AR) Patients Based on the Methotrexate Dose Randomization
DFS is calculated as the time from randomization at the end of interim maintenance II to first event (relapse, second malignancy, remission death) or date of last contact. Five year DFS estimates will be calculated from the point of randomization for both groups. Two-sided 95% confidence intervals will be calculated.
5.7 years
DFS in Average Risk (AR) Patients Based on the Pulse Frequency Randomization
DFS is calculated as the time from randomization at the end of interim maintenance II to first event (relapse, second malignancy, remission death) or date of last contact. Five year DFS estimates will be calculated from the point of randomization for both groups. Two-sided 95% confidence intervals will be calculated.
5.7 years
DFS in Low Risk (LR) Patients Based on Randomization to 1 of 2 Low-intensity Regimens
DFS is calculated as the time from randomization at the end of Induction to first event (relapse, second malignancy, remission death) or date of last contact. Five year DFS estimates will be calculated from the point of randomization for both groups. Two-sided 95% confidence intervals will be calculated.
5.1 years
DFS for SR Down Syndrome Patients With Standardized Treatment and Enhanced Supportive Care
DFS is calculated as the time from end of Induction to first event (relapse, second malignancy, remission death) or date of last contact. The 5-year DFS and 95% confidence interval for these patients will be estimated.
5.1 years
Sample Collection of Central Path Review Slides in B-LLy Patients
Percent of B-LLy patients who had adequate/usable samples of samples collected will be reported.
Secondary Outcomes
Measure
Description
Time Frame
Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Emotional
Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
2 Months
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: Emotional
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
B-ALL patients must be enrolled on AALL08B1 or APEC14B1 (if open for the classification of newly diagnosed ALL patients) prior to treatment and enrollment on AALL0932
Note: B-LLy patients are not eligible for AALL08B1, and can enroll directly onto AALL0932
B-ALL patients must have an initial white blood cell count < 50,000/uL
Patients must have newly diagnosed National Cancer Institute (NCI) Standard Risk B-ALL or B-LLy Murphy stages I or II; patients with Down syndrome are also eligible
Note: for B-LLy patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to B-ALL; for tissue processed by other means (i.e. paraffin blocks), the methodology and criteria for immunophenotypic analysis to establish the diagnosis of B-LLy defined by the submitting institution will be accepted
All patients and/or their parents or legal guardians must sign a written informed consent
All institutional, Food and Drug Administration (FDA), and NCI requirements for human studies must be met
Exclusion Criteria:
With the exception of steroid pretreatment (defined below) or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B-ALL or B-LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL0932
Patients receiving prior steroid therapy may be eligible for AALL0932
Patients with central nervous system 3 (CNS3) leukemia
CNS status must be known prior to enrollment; (Note: the CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment); B-LLy patients with CNS3 disease are not eligible for this protocol or the COG HR ALL protocol; it is recommended that intrathecal cytarabine be administered at the time of the diagnostic lumbar puncture; this is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture; this is allowed prior to registration; systemic chemotherapy must begin within 72 hours of the first dose of intrathecal therapy
B-ALL patients with testicular leukemia are not eligible for AALL0932
For B-LLy patients the following additional exclusion criteria apply:
T-lymphoblastic lymphoma
Morphologically unclassifiable lymphoma
Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma
CNS3-positive disease or testicular involvement
M2 (5% - 25% blasts) or M3 (> 25% blasts) marrow
Female patients who are pregnant are ineligible
Lactating females are not eligible unless they have agreed not to breastfeed their infants
Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained
Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation
Chen W, Chang TC, Rabin KR, Raetz EA, Devidas M, Hunger SP, Ramirez NC, Mullighan CG, Loh ML, Wu G. Performance of Two-Phase Designs for the Time-to-Event Outcome and a Case Study Assessing the Relapse Risk Associated With B-ALL Subtypes. JCO Clin Cancer Inform. 2025 May;9:e2400223. doi: 10.1200/CCI-24-00223. Epub 2025 May 2.
Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Patients were stratified between 2 disease groups (B-ALL and B-LLY) for Induction and then risk assigned treatment based upon the patient's response.
Recruitment Details
Newly Diagnosed Standard Risk B-Lymphoblastic Leukemia (B-ALL) or Localized B-lineage Lymphoblastic Lymphoma (B-LLy)
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
B-ALL
All patients receive induction therapy comprising intrathecal (IT) cytarabine on day 1; vincristine sulfate IV on days 1, 8, 15, and 22; dexamethasone orally (PO) or IV twice daily (BID) on days 1-28; pegaspargase IV over 1-2 hours on day 4; and IT methotrexate on days 8 and 29. Patients with DS also receive leucovorin calcium every 12 hours on days 10-11 and 21-32. Patients with Philadelphia chromosome-positive disease are eligible to transfer to COG-AALL0622 by day 15 of induction therapy and patients with high-risk (HR) or very high-risk (VHR) disease are eligible to transfer to a COG HR or VHR trial at the end of induction therapy. Patients with standard-risk disease with Down syndrome (DS) who have bone marrow minimal residual disease 0.01% are eligible to transfer to the DS stratum of the HR trial. Patients with induction failure (defined as M3 [> 25% lymphoblasts] on day 29) may be eligible for the COG VHR-acute lymphoblastic leukemia study.
Periods
Title
Milestones
Reasons Not Completed
Induction
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Oct 26, 2017
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
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
Parallel 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: Vincristine Sulfate
Arm C (risk-adapted chemotherapy)
Experimental
Patients receive vincristine sulfate IV on day 1; dexamethasone PO BID on days 1-5; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.
Drug: Dexamethasone
Other: Laboratory Biomarker Analysis
Drug: Mercaptopurine
Drug: Methotrexate
Other: Quality-of-Life Assessment
Other: Questionnaire Administration
Drug: Vincristine Sulfate
Arm D (risk-adapted chemotherapy)
Experimental
Patients receive vincristine sulfate IV on day 1; dexamethasone PO BID on days 1-5; higher-dose methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.
Drug: Dexamethasone
Other: Laboratory Biomarker Analysis
Drug: Mercaptopurine
Drug: Methotrexate
Other: Quality-of-Life Assessment
Other: Questionnaire Administration
Drug: Vincristine Sulfate
Arm LR-C (risk-adapted chemotherapy)
Experimental
Patients receive consolidation, interim maintenance I, delayed intensification, interim maintenance II, and maintenance therapy. See detailed description.
Drug: Cyclophosphamide
Drug: Cytarabine
Drug: Dexamethasone
Drug: Doxorubicin Hydrochloride
Other: Laboratory Biomarker Analysis
Drug: Mercaptopurine
Drug: Methotrexate
Drug: Pegaspargase
Other: Quality-of-Life Assessment
Other: Questionnaire Administration
Drug: Thioguanine
Drug: Vincristine Sulfate
Arm LR-M (risk-adapted chemotherapy)
Experimental
Patients receive consolidation and maintenance therapy. See detailed description.
EFS is calculated as the Time from study enrollment to first event (induction failure, relapse, second malignancy, remission death) or date of last contact. The 5-year EFS and 95% confidence interval for these patients will be estimated.
5 years
Overall Survival (OS) for B-LLy Patients
OS is calculated as the time from study enrollment to death or date of last contact. The 5-year OS and 95% confidence interval for these patients will be estimated.
5 years
Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
1 year
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: Emotional
Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
1.7 years
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Emotional
Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
2.5 years
Burden of Therapy in Boy AR Patients Overall at End of Therapy: Emotional
Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Genetic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
3.2 years
Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Physical
Age and gender standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
2 Months
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: Physical
Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
1 Year
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: Physical
Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
1.7 years
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Physical
Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
2.4 Years
Burden of Therapy in Boy AR Patients Overall at End of Therapy: Physical
Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
3.2 years
Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: School
Age standardized Quality of life, measured by the school subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
2 Months
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: School
Age standardized Quality of life, measured by the school subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
1 Year
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: School
Age standardized Quality of life, measured by the school subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
1.7 Years
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): School
Age standardized Quality of life, measured by the school subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
2.4 years
Burden of Therapy in Boy AR Patients Overall at End of Therapy: School
Age standardized Quality of life, measured by the school subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
3.2 Years
Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Social Functioning
Age standardized Quality of life, measured by the social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
2 Months
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: Social Functioning
Age standardized Quality of life, measured by the social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
1 Year
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: Social Functioning
Age standardized Quality of life, measured by the social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
1.7 Years
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Social Functioning
Age standardized Quality of life, measured by the social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
2.4 Years
Burden of Therapy in Boy AR Patients Overall at End of Therapy: Social Functioning
Age standardized Quality of life, measured by the Social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
3.2 Years
Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 4: Emotional
Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with means and standard deviation reported.
1.7 years
Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Emotional
Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported.
2.4 Years
Burden of Therapy in Boy AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Therapy: Emotional
Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported.
3.2 Years
Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 4: Physical
Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with means and standard deviation reported.
1.7 Years
Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Physical
Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported.
2.4 Years
Burden of Therapy in Boy AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Therapy: Physical
Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported.
3.2 Years
Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 4: School
Age standardized Quality of life, measured by the school subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with means and standard deviation reported.
1.7 Years
Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): School
Age standardized Quality of life, measured by the school subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported.
2.4 Years
Burden of Therapy in Boy AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Therapy: School
Age standardized Quality of life, measured by the school subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported.
3.2 Years
Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 4: Social Functioning
Age standardized Quality of life, measured by the social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with means and standard deviation reported.
1.7 Years
Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Social Functioning
Age standardized Quality of life, measured by the social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported.
2.4 Years
Burden of Therapy in Boy AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Therapy: Social Functioning
Age standardized Quality of life, measured by the social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported.
3.2 Years
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Consolidation Therapy-Right
Strength in the right ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for the cohort will be reported.
2 Months
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Consolidation Therapy-Left
Strength in the left ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for the cohort will be reported.
2 Months
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Maintenance Cycle 1: Right
Strength in the right ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for the cohort will be reported.
1 Year
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Maintenance Cycle 1: Left
Strength in the left ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for the cohort will be reported.
1 Year
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Right
Strength in the right ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for the cohort will be reported.
2.4 Years
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Left
Strength in the left ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for the cohort will be reported.
2.4 Years
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL 12 Months Post Therapy: Right
Strength in the right ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for the cohort will be reported.
4.2 Years
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL 12 Months Post Therapy: Left
Strength in the left ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for the cohort will be reported.
4.2 Years
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Right
Strength in the right ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for each randomization group will be reported.
2.4 Years
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Left
Strength in the left ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for each randomization group will be reported.
2.4 Years
Birmingham
Alabama
35233
United States
USA Health Strada Patient Care Center
Mobile
Alabama
36604
United States
Providence Alaska Medical Center
Anchorage
Alaska
99508
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
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
Naval Medical Center -San Diego
San Diego
California
92134
United States
UCSF Medical Center-Parnassus
San Francisco
California
94143
United States
UCSF Medical Center-Mission Bay
San Francisco
California
94158
United States
Santa Barbara Cottage Hospital
Santa Barbara
California
93102
United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance
California
90502
United States
Children's Hospital Colorado
Aurora
Colorado
80045
United States
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Denver
Colorado
80218
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
UF Health Cancer Institute - 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
Arnold Palmer Hospital for Children
Orlando
Florida
32806
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
Johns Hopkins All Children's Hospital
St. Petersburg
Florida
33701
United States
Tampa General Hospital
Tampa
Florida
33606
United States
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa
Florida
33607
United States
Saint Mary's Medical Center
West Palm Beach
Florida
33407
United States
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta
Georgia
30329
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
Kapiolani Medical Center for Women and Children
Honolulu
Hawaii
96826
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
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 Children's Hospital-Park Ridge
Park Ridge
Illinois
60068
United States
Advocate Lutheran General Hospital
Park Ridge
Illinois
60068
United States
OSF Children's Hospital of Illinois
Peoria
Illinois
61637
United States
Southern Illinois University School of Medicine
Springfield
Illinois
62702
United States
Riley Hospital for Children
Indianapolis
Indiana
46202
United States
Ascension Saint Vincent Indianapolis Hospital
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 Kentucky/Markey Cancer Center
Lexington
Kentucky
40536
United States
Norton Children's Hospital
Louisville
Kentucky
40202
United States
Tulane University School of Medicine
New Orleans
Louisiana
70112
United States
Children's Hospital New Orleans
New Orleans
Louisiana
70118
United States
Ochsner Medical Center Jefferson
New Orleans
Louisiana
70121
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
Henry Ford Health Saint John Hospital
Detroit
Michigan
48236
United States
Michigan State University
East Lansing
Michigan
48823
United States
Hurley Medical Center
Flint
Michigan
48503
United States
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids
Michigan
49503
United States
Bronson Methodist Hospital
Kalamazoo
Michigan
49007
United States
Kalamazoo Center for Medical Studies
Kalamazoo
Michigan
49008
United States
Corewell Health Children's
Royal Oak
Michigan
48073
United States
Corewell Health William Beaumont University Hospital
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
University of Mississippi Medical Center
Jackson
Mississippi
39216
United States
University of Missouri Children's Hospital
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
Mercy Hospital Saint Louis
St Louis
Missouri
63141
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
University Medical Center of Southern Nevada
Las Vegas
Nevada
89102
United States
Sunrise Hospital and Medical Center
Las Vegas
Nevada
89109
United States
Nevada Cancer Research Foundation NCORP
Las Vegas
Nevada
89120
United States
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas
Nevada
89135
United States
Summerlin Hospital Medical Center
Las Vegas
Nevada
89144
United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer 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
87106
United States
Albany Medical Center
Albany
New York
12208
United States
Brooklyn Hospital Center
Brooklyn
New York
11201
United States
Roswell Park Cancer Institute
Buffalo
New York
14263
United States
NYU Langone Hospital - Long Island
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
Memorial Sloan Kettering Cancer Center
New York
New York
10065
United States
NYP/Weill Cornell Medical Center
New York
New York
10065
United States
University of Rochester
Rochester
New York
14642
United States
Stony Brook University Medical Center
Stony Brook
New York
11794
United States
State University of New York Upstate Medical University
Angiolillo AL, Schore RJ, Kairalla JA, Devidas M, Rabin KR, Zweidler-McKay P, Borowitz MJ, Wood B, Carroll AJ, Heerema NA, Relling MV, Hitzler J, Lane AR, Maloney KW, Wang C, Bassal M, Carroll WL, Winick NJ, Raetz EA, Loh ML, Hunger SP. Excellent Outcomes With Reduced Frequency of Vincristine and Dexamethasone Pulses in Standard-Risk B-Lymphoblastic Leukemia: Results From Children's Oncology Group AALL0932. J Clin Oncol. 2021 May 1;39(13):1437-1447. doi: 10.1200/JCO.20.00494. Epub 2021 Jan 7.
Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive
FG001
B-LLy
Induction: same trt as B-ALL; Consolidation (4 wks): vincristine sulfate day 1; mercaptopurine days 1-28; IT methotrexate (MTX) days 1/8/15; leucovorin calcium days 3-4,10-11,17-18 Interim maintenance I (8 wks): vincristine sulfate and MTX 2-15 min days 1/11/21/31/41; IT MTX day 31; leucovorin calcium days 33-34 Delayed-intensification (8 wks): dexamethasone days 1-7 and 15-21; vincristine sulfate and doxorubicin hydrochloride on days 1/8/15; pegaspargase 1-2 hrs day 4; cyclophosphamide day 29; thioguanine days 29-42; cytarabine 29-32, 33-39; IT MTX days 1/29; and leucovorin calcium days 3-4, 31-32 Interim maintenance II (8 wks): vincristine sulfate and MTX days 1/11/21/31/41; IT MTX days 1/31; and leucovorin calcium days 3-4, 33/34 Maintenance: vincristine sulfate day 1; dexamethasone days 1-5; MTX weekly days 8-78; mercaptopurine days 1-84; and IT MTX day 1. Courses repeat every 4 wks for 2 yrs (from the start of IMI therapy).
FG002
B-ALL Average Risk
Consolidation (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34
FG003
Standard Risk With Down Syndrome
Consolidation (4 w): vincristine (VIN) d1; MP d1-28; IT methotrexate (MTX) d1/8/15; leucovorin (LV) d3-4/10-11/17-18 Interim maintenance I (8 wks): VIN & IV MTX d1/11/21/31/41; IT MTX d31; LV d36-34 Delayed-intensification (8 wks): Patients receive dexamethasone (DEX) d1-7/15-21; VIN & doxorubicin d1/8/15; pegaspargase d4; cyclophosphamide d29; thioguanine d 29-42; cytarabine d29-32/33-39; IT MTX d1/29; and LV d3-4/31-32 Interim maintenance II (8 wks): VIN & IV MTX d1/11/21/31/41; IT MTX d1/31; and LV d3-4/33-34 Maintenance: VIN d1; DEX d1-5; PO MTX wkly d8-78; MP d1-84; and IT MTX d1. Courses repeat every 12 wks for 2 years (timed from the start of interim maintenance I therapy).
FG004
B-ALL Low Risk Arm I (LR-M)
Consolidation (19 w): vincristine (VIN) day(d) 15/22/78/85; IV/IT methotrexate (MTX) d8/29/50/71/92/113; leucovorin (LV) d9-10/30-31/51-52/72-73/93-94/114-115; dexamethasone (DEX) d15-21/78-84; mercaptopurine (MP) d 1-133. Maint.: VIN d1/8; DEX d1-7; MTX* PO wkly d1-106; MP d 1-112. Repeat every 16 w until 2.5 yrs from dx. IT MTX d1/85 (course 1&4), d 57 (course 2&5), d29 (course 3&6). Course 7: VIN d1/8; DEX d 1-7; MTX PO wkly d8-64; and MP d1-70. *Patients do not receive MTX PO on d w/ IT MTX.
FG005
B-ALL Low Risk Arm II (LR-C)
Consolidation (4 w): VIN d1; MP d1-28; IT MTX d1/8/15 Interim Maint. I (8 w): VIN & IV MTX d1/11/21/31/41; IT MTX d31 Delayed-intensification (8 w): DEX d1-7/15-21; VIN & doxorubicin d1/8/15; pegaspargase d4; cyclophosphamide d29; thioguanine d 29-42; cytarabine d29-32/36-39; IT MTX d1/29 Interim Maint. II (8 w): VIN & IV MTX d1/11/21/31/41; IT MTX d1/31 Maint.: VIN d1; DEX d1-5; MTX PO wkly d22-78; MP d 1-84; IT MTX d1. Rpt every 12 w for 2 yrs:girls, 3 yrs:boys from start IM1
FG006
B-ALL Average Risk-Arm A
Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1+P8:W8-84; and IT MTX d 1
FG007
B-ALL Average Risk-Arm B
Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1
FG008
B-ALL Average Risk-Arm C
Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1
FG009
B-ALL Average Risk-Arm D
Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
FG0009298 subjects
FG00152 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
COMPLETED
FG0003949 subjects
FG00143 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
NOT COMPLETED
FG0005349 subjects
FG0019 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Type
Comment
Reasons
Adverse Event
FG00017 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Death
FG00034 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG000125 subjects
FG0013 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0009 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Refusal
FG000235 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Inevaluable
FG00023 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
BM MRD >= 0.01% on Day 29 of Induction
FG00061 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
High Risk Downs
FG00080 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Enrollment onto another COG Protocol
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Average Risk
FG0001847 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
High Risk
FG0001227 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Low Risk
FG000443 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Very High Risk
FG0001012 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Philadelphia chromosome-positive
FG00099 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Incomplete Induction data
FG00063 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Progressive disease
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
No treatment
FG0003 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Ineligible
FG00069 subjects
FG0014 subjects
FG0020 subjects
FG0030 subjects
FG004
Post Induction Pre-Maintenance
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG00143 subjects
FG0023122 subjects
FG003224 subjects
FG004301 subjects
FG005302 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
COMPLETED
FG0000 subjects
FG00137 subjects
FG0022364 subjects
FG003207 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0016 subjects
FG002758 subjects
FG00317 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0028 subjects
FG003
Maintenance
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG00137 subjects
FG0020 subjects
FG003207 subjects
FG004296 subjects
FG005296 subjects
FG006600 subjects
FG007586 subjects
FG008586 subjects
FG009592 subjects
COMPLETED
FG0000 subjects
FG00127 subjects
FG0020 subjects
FG003167 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG00110 subjects
FG0020 subjects
FG00340 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Baseline data were collected according to the Arms from the Induction period (1. B-ALL; 2. B-LLy)
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
B-ALL
All B-ALL patients
BG001
B-LLy
All B-LLy patients
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0009298
BG00152
BG0029350
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
BG0009298
BG00151
BG0029349
Between 18 and 65 years
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG0004.57± 2.12
BG0019.19± 4.40
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0004294
BG00127
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0002132
BG00115
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG00094
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
Disease Free Survival (DFS) in Average Risk (AR) Patients Based on the Methotrexate Dose Randomization
DFS is calculated as the time from randomization at the end of interim maintenance II to first event (relapse, second malignancy, remission death) or date of last contact. Five year DFS estimates will be calculated from the point of randomization for both groups. Two-sided 95% confidence intervals will be calculated.
Average Risk (AR) B-ALL patients who were randomized and started maintenance
Posted
Number
95% Confidence Interval
percent probability
5.7 years
ID
Title
Description
OG000
B-ALL Average Risk: MTX 20 mg/m^2/Week Starting Dose
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
OG001
B-ALL Average Risk: MTX 40 mg/m^2/Week Starting Dose
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
Units
Counts
Participants
OG0001186
OG0011178
Title
Denominators
Categories
Title
Measurements
OG00095.05(93.27 to 96.83)
OG00194.17(92.23 to 96.11)
Primary
DFS in Average Risk (AR) Patients Based on the Pulse Frequency Randomization
DFS is calculated as the time from randomization at the end of interim maintenance II to first event (relapse, second malignancy, remission death) or date of last contact. Five year DFS estimates will be calculated from the point of randomization for both groups. Two-sided 95% confidence intervals will be calculated.
Average Risk (AR) B-ALL patients who were randomized and started maintenance
Posted
Number
95% Confidence Interval
percent probability
5.7 years
ID
Title
Description
OG000
B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
OG001
B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks
Primary
DFS in Low Risk (LR) Patients Based on Randomization to 1 of 2 Low-intensity Regimens
DFS is calculated as the time from randomization at the end of Induction to first event (relapse, second malignancy, remission death) or date of last contact. Five year DFS estimates will be calculated from the point of randomization for both groups. Two-sided 95% confidence intervals will be calculated.
Posted
Number
95% Confidence Interval
percent probability
5.1 years
ID
Title
Description
OG000
B-ALL Low Risk Arm I (LR-M)
Consolidation (19 w): vincristine (VIN) day(d) 15/22/78/85; IV/IT methotrexate (MTX) d8/29/50/71/92/113; leucovorin (LV) d9-10/30-31/51-52/72-73/93-94/114-115; dexamethasone (DEX) d15-21/78-84; mercaptopurine (MP) d 1-133. Maint.: VIN d1/8; DEX d1-7; MTX* PO wkly d1-106; MP d 1-112. Repeat every 16 w until 2.5 yrs from dx. IT MTX d1/85 (course 1&4), d 57 (course 2&5), d29 (course 3&6). Course 7: VIN d1/8; DEX d 1-7; MTX PO wkly d8-64; and MP d1-70. *Patients do not receive MTX PO on d w/ IT MTX.
OG001
B-ALL Low Risk Arm II (LR-C)
Consolidation (4 w): VIN d1; MP d1-28; IT MTX d1/8/15 Interim Maint. I (8 w): VIN & IV MTX d1/11/21/31/41; IT MTX d31 Delayed-intensification (8 w): DEX d1-7/15-21; VIN & doxorubicin d1/8/15; pegaspargase d4; cyclophosphamide d29; thioguanine d 29-42; cytarabine d29-32/36-39; IT MTX d1/29 Interim Maint. II (8 w): VIN & IV MTX d1/11/21/31/41; IT MTX d1/31 Maint.: VIN d1; DEX d1-5; MTX PO wkly d22-78; MP d 1-84; IT MTX d1. Rpt every 12 w for 2 yrs:girls, 3 yrs:boys from start IM1
Primary
DFS for SR Down Syndrome Patients With Standardized Treatment and Enhanced Supportive Care
DFS is calculated as the time from end of Induction to first event (relapse, second malignancy, remission death) or date of last contact. The 5-year DFS and 95% confidence interval for these patients will be estimated.
Posted
Number
95% Confidence Interval
percent probability
5.1 years
ID
Title
Description
OG000
Standard Risk With Down Syndrome
Consolidation (4 w): vincristine (VIN) d1; MP d1-28; IT methotrexate (MTX) d1/8/15; leucovorin (LV) d3-4/10-11/17-18 Interim maintenance I (8 wks): VIN & IV MTX d1/11/21/31/41; IT MTX d31; LV d36-34 Delayed-intensification (8 wks): Patients receive dexamethasone (DEX) d1-7/15-21; VIN & doxorubicin d1/8/15; pegaspargase d4; cyclophosphamide d29; thioguanine d 29-42; cytarabine d29-32/33-39; IT MTX d1/29; and LV d3-4/31-32 Interim maintenance II (8 wks): VIN & IV MTX d1/11/21/31/41; IT MTX d1/31; and LV d3-4/33-34 Maintenance: VIN d1; DEX d1-5; PO MTX wkly d8-78; MP d1-84; and IT MTX d1. Courses repeat every 12 wks for 2 years (timed from the start of interim maintenance I therapy).
Units
Counts
Participants
OG000
Primary
Sample Collection of Central Path Review Slides in B-LLy Patients
Percent of B-LLy patients who had adequate/usable samples of samples collected will be reported.
patients who had samples collected near diagnosis
Posted
Number
95% Confidence Interval
percentage of patients
Up to 1 month
ID
Title
Description
OG000
B-LLy
Induction: same trt as B-ALL; Consolidation (4 wks): vincristine sulfate day 1; mercaptopurine days 1-28; IT methotrexate (MTX) days 1/8/15; leucovorin calcium days 3-4,10-11,17-18 Interim maintenance I (8 wks): vincristine sulfate and MTX 2-15 min days 1/11/21/31/41; IT MTX day 31; leucovorin calcium days 33-34 Delayed-intensification (8 wks): dexamethasone days 1-7 and 15-21; vincristine sulfate and doxorubicin hydrochloride on days 1/8/15; pegaspargase 1-2 hrs day 4; cyclophosphamide day 29; thioguanine days 29-42; cytarabine 29-32, 33-39; IT MTX days 1/29; and leucovorin calcium days 3-4, 31-32 Interim maintenance II (8 wks): vincristine sulfate and MTX days 1/11/21/31/41; IT MTX days 1/31; and leucovorin calcium days 3-4, 33/34 Maintenance: vincristine sulfate day 1; dexamethasone days 1-5; MTX weekly days 8-78; mercaptopurine days 1-84; and IT MTX day 1. Courses repeat every 4 wks for 2 yrs (from the start of IMI therapy).
Units
Counts
Participants
Primary
Event Free Survival (EFS) for B-LLy Patients
EFS is calculated as the Time from study enrollment to first event (induction failure, relapse, second malignancy, remission death) or date of last contact. The 5-year EFS and 95% confidence interval for these patients will be estimated.
Ineligible patients are excluded
Posted
Number
95% Confidence Interval
percent probability
5 years
ID
Title
Description
OG000
B-LLy
Induction: same trt as B-ALL; Consolidation (4 wks): vincristine sulfate day 1; mercaptopurine days 1-28; IT methotrexate (MTX) days 1/8/15; leucovorin calcium days 3-4,10-11,17-18 Interim maintenance I (8 wks): vincristine sulfate and MTX 2-15 min days 1/11/21/31/41; IT MTX day 31; leucovorin calcium days 33-34 Delayed-intensification (8 wks): dexamethasone days 1-7 and 15-21; vincristine sulfate and doxorubicin hydrochloride on days 1/8/15; pegaspargase 1-2 hrs day 4; cyclophosphamide day 29; thioguanine days 29-42; cytarabine 29-32, 33-39; IT MTX days 1/29; and leucovorin calcium days 3-4, 31-32 Interim maintenance II (8 wks): vincristine sulfate and MTX days 1/11/21/31/41; IT MTX days 1/31; and leucovorin calcium days 3-4, 33/34 Maintenance: vincristine sulfate day 1; dexamethasone days 1-5; MTX weekly days 8-78; mercaptopurine days 1-84; and IT MTX day 1. Courses repeat every 4 wks for 2 yrs (from the start of IMI therapy).
Units
Counts
Participants
Primary
Overall Survival (OS) for B-LLy Patients
OS is calculated as the time from study enrollment to death or date of last contact. The 5-year OS and 95% confidence interval for these patients will be estimated.
Ineligible patients are excluded
Posted
Number
95% Confidence Interval
percent probability
5 years
ID
Title
Description
OG000
B-LLy
Induction: same trt as B-ALL Consolidation (4 wks): vincristine sulfate day 1; mercaptopurine days 1-28; IT methotrexate (MTX) days 1/8/15; leucovorin calcium days 3-4,10-11,17-18 Interim maintenance I (8 wks): vincristine sulfate and MTX 2-15 min days 1/11/21/31/41; IT MTX day 31; leucovorin calcium days 33-34 Delayed-intensification (8 wks): dexamethasone days 1-7 and 15-21; vincristine sulfate and doxorubicin hydrochloride on days 1/8/15; pegaspargase 1-2 hrs day 4; cyclophosphamide day 29; thioguanine days 29-42; cytarabine 29-32, 33-39; IT MTX days 1/29; and leucovorin calcium days 3-4, 31-32 Interim maintenance II (8 wks): vincristine sulfate and MTX days 1/11/21/31/41; IT MTX days 1/31; and leucovorin calcium days 3-4, 33/34 Maintenance: vincristine sulfate day 1; dexamethasone days 1-5; MTX weekly days 8-78; mercaptopurine days 1-84; and IT MTX day 1. Courses repeat every 4 wks for 2 yrs (from the start of IMI therapy).
Units
Counts
Participants
Secondary
Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Emotional
Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
AR patients who had data collected
Posted
Mean
Standard Deviation
Z-Score
2 Months
ID
Title
Description
OG000
B-ALL Average Risk
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
Units
Counts
Participants
Secondary
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: Emotional
Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
AR patients who had data collected
Posted
Mean
Standard Deviation
Z-Score
1 year
ID
Title
Description
OG000
B-ALL Average Risk
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
Units
Counts
Participants
Secondary
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: Emotional
Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
AR patients who had data collected
Posted
Mean
Standard Deviation
Z-Score
1.7 years
ID
Title
Description
OG000
B-ALL Average Risk
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
Units
Counts
Participants
Secondary
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Emotional
Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
AR patients who had data collected
Posted
Mean
Standard Deviation
Z-Score
2.5 years
ID
Title
Description
OG000
B-ALL Average Risk
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
Units
Counts
Secondary
Burden of Therapy in Boy AR Patients Overall at End of Therapy: Emotional
Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Genetic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
AR boy patients who had data collected
Posted
Mean
Standard Deviation
Z-Score
3.2 years
ID
Title
Description
OG000
B-ALL Average Risk
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
Units
Counts
Participants
Secondary
Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Physical
Age and gender standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
AR patients who had data collected
Posted
Mean
Standard Deviation
Z-Score
2 Months
ID
Title
Description
OG000
B-ALL Average Risk
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
Units
Counts
Participants
Secondary
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: Physical
Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
AR patients who had data collected
Posted
Mean
Standard Deviation
Z-Score
1 Year
ID
Title
Description
OG000
B-ALL Average Risk
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
Units
Counts
Participants
Secondary
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: Physical
Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
AR patients who had data collected
Posted
Mean
Standard Deviation
Z-Score
1.7 years
ID
Title
Description
OG000
B-ALL Average Risk
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
Units
Counts
Participants
Secondary
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Physical
Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
AR patients who had data collected
Posted
Mean
Standard Deviation
Z-Score
2.4 Years
ID
Title
Description
OG000
B-ALL Average Risk
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
Units
Counts
Participants
Secondary
Burden of Therapy in Boy AR Patients Overall at End of Therapy: Physical
Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
AR boy patients who had data collected
Posted
Mean
Standard Deviation
Z-Score
3.2 years
ID
Title
Description
OG000
B-ALL Average Risk
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
Units
Counts
Participants
Secondary
Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: School
Age standardized Quality of life, measured by the school subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
Data are unavailable
Posted
2 Months
ID
Title
Description
OG000
B-ALL Average Risk
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
Units
Counts
Participants
Secondary
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: School
Age standardized Quality of life, measured by the school subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
Data are unavailable
Posted
1 Year
ID
Title
Description
OG000
B-ALL Average Risk
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
Units
Counts
Participants
Secondary
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: School
Age standardized Quality of life, measured by the school subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
Data are unavailable
Posted
1.7 Years
ID
Title
Description
OG000
B-ALL Average Risk
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
Units
Counts
Participants
Secondary
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): School
Age standardized Quality of life, measured by the school subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
Data are unavailable
Posted
2.4 years
ID
Title
Description
OG000
B-ALL Average Risk
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
Units
Counts
Participants
Secondary
Burden of Therapy in Boy AR Patients Overall at End of Therapy: School
Age standardized Quality of life, measured by the school subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
Data are unavailable
Posted
3.2 Years
ID
Title
Description
OG000
B-ALL Average Risk
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
Units
Counts
Participants
Secondary
Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Social Functioning
Age standardized Quality of life, measured by the social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
AR patients who had data collected
Posted
Mean
Standard Deviation
Z-Score
2 Months
ID
Title
Description
OG000
B-ALL Average Risk
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
Units
Counts
Participants
Secondary
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: Social Functioning
Age standardized Quality of life, measured by the social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
AR patients who had data collected
Posted
Mean
Standard Deviation
Z-Score
1 Year
ID
Title
Description
OG000
B-ALL Average Risk
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
Units
Counts
Participants
Secondary
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: Social Functioning
Age standardized Quality of life, measured by the social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
AR patients who had data collected
Posted
Mean
Standard Deviation
Z-Score
1.7 Years
ID
Title
Description
OG000
B-ALL Average Risk
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
Units
Counts
Participants
Secondary
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Social Functioning
Age standardized Quality of life, measured by the social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
AR patients who had data collected
Posted
Mean
Standard Deviation
Z-Score
2.4 Years
ID
Title
Description
OG000
B-ALL Average Risk
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
Units
Counts
Secondary
Burden of Therapy in Boy AR Patients Overall at End of Therapy: Social Functioning
Age standardized Quality of life, measured by the Social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
AR boy patients who had data collected
Posted
Mean
Standard Deviation
Z-Score
3.2 Years
ID
Title
Description
OG000
B-ALL Average Risk
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
Units
Counts
Participants
Secondary
Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 4: Emotional
Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with means and standard deviation reported.
AR patients who had data collected
Posted
Mean
Standard Deviation
Z-Score
1.7 years
ID
Title
Description
OG000
B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
OG001
B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks
Secondary
Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Emotional
Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported.
AR patients who had data collected
Posted
Mean
Standard Deviation
Z-Score
2.4 Years
ID
Title
Description
OG000
B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
OG001
B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks
Secondary
Burden of Therapy in Boy AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Therapy: Emotional
Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported.
AR boy patients who had data collected
Posted
Mean
Standard Deviation
Z-Score
3.2 Years
ID
Title
Description
OG000
B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
OG001
B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks
Secondary
Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 4: Physical
Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with means and standard deviation reported.
AR patients who had data collected
Posted
Mean
Standard Deviation
Z-Score
1.7 Years
ID
Title
Description
OG000
B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
OG001
B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks
Secondary
Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Physical
Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported.
AR patients who had data collected
Posted
Mean
Standard Deviation
Z-Score
2.4 Years
ID
Title
Description
OG000
B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
OG001
B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks
Secondary
Burden of Therapy in Boy AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Therapy: Physical
Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported.
AR boy patients who had data collected
Posted
Mean
Standard Deviation
Z-Score
3.2 Years
ID
Title
Description
OG000
B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
OG001
B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks
Secondary
Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 4: School
Age standardized Quality of life, measured by the school subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with means and standard deviation reported.
Data are unavailable
Posted
1.7 Years
ID
Title
Description
OG000
B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
OG001
B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
Secondary
Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): School
Age standardized Quality of life, measured by the school subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported.
Data are unavailable
Posted
2.4 Years
ID
Title
Description
OG000
B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
OG001
B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks
Secondary
Burden of Therapy in Boy AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Therapy: School
Age standardized Quality of life, measured by the school subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported.
Data are unavailable
Posted
3.2 Years
ID
Title
Description
OG000
B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
OG001
B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
Secondary
Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 4: Social Functioning
Age standardized Quality of life, measured by the social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with means and standard deviation reported.
AR patients who had data collected
Posted
Mean
Standard Deviation
Z-Score
1.7 Years
ID
Title
Description
OG000
B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
OG001
B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks
Secondary
Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Social Functioning
Age standardized Quality of life, measured by the social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported.
AR patients who had data collected
Posted
Mean
Standard Deviation
Z-Score
2.4 Years
ID
Title
Description
OG000
B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
OG001
B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks
Secondary
Burden of Therapy in Boy AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Therapy: Social Functioning
Age standardized Quality of life, measured by the social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported.
AR boy patients who had data collected
Posted
Mean
Standard Deviation
Z-Score
3.2 Years
ID
Title
Description
OG000
B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
OG001
B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks
Secondary
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Consolidation Therapy-Right
Strength in the right ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for the cohort will be reported.
AR patients who had data collected
Posted
Mean
Standard Deviation
Z-Score
2 Months
ID
Title
Description
OG000
B-ALL Average Risk
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
Units
Counts
Participants
Secondary
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Consolidation Therapy-Left
Strength in the left ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for the cohort will be reported.
AR patients who had data collected
Posted
Mean
Standard Deviation
Z-Score
2 Months
ID
Title
Description
OG000
B-ALL Average Risk
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
Units
Counts
Participants
Secondary
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Maintenance Cycle 1: Right
Strength in the right ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for the cohort will be reported.
AR patients who had data collected
Posted
Mean
Standard Deviation
Z-Score
1 Year
ID
Title
Description
OG000
B-ALL Average Risk
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
Units
Counts
Participants
Secondary
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Maintenance Cycle 1: Left
Strength in the left ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for the cohort will be reported.
AR patients who had data collected
Posted
Mean
Standard Deviation
Z-Score
1 Year
ID
Title
Description
OG000
B-ALL Average Risk
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
Units
Counts
Participants
Secondary
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Right
Strength in the right ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for the cohort will be reported.
AR patients who had data collected
Posted
Mean
Standard Deviation
Z-Score
2.4 Years
ID
Title
Description
OG000
B-ALL Average Risk
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
Units
Counts
Secondary
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Left
Strength in the left ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for the cohort will be reported.
AR patients who had data collected
Posted
Mean
Standard Deviation
Z-Score
2.4 Years
ID
Title
Description
OG000
B-ALL Average Risk
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
Units
Counts
Secondary
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL 12 Months Post Therapy: Right
Strength in the right ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for the cohort will be reported.
AR patients who had data collected
Posted
Mean
Standard Deviation
Z-Score
4.2 Years
ID
Title
Description
OG000
B-ALL Average Risk
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
Units
Counts
Participants
Secondary
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL 12 Months Post Therapy: Left
Strength in the left ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for the cohort will be reported.
AR patients who had data collected
Posted
Mean
Standard Deviation
Z-Score
4.2 Years
ID
Title
Description
OG000
B-ALL Average Risk
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
Units
Counts
Participants
Secondary
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Right
Strength in the right ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for each randomization group will be reported.
AR patients who had data collected
Posted
Mean
Standard Deviation
Z-Score
2.4 Years
ID
Title
Description
OG000
B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayedintensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int.
maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
OG001
B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks
Secondary
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Left
Strength in the left ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for each randomization group will be reported.
AR patients who had data collected
Posted
Mean
Standard Deviation
Z-Score
2.4 Years
ID
Title
Description
OG000
B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayedintensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int.
maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
OG001
B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks
Time Frame
Up to 9 years
Description
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
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
B-ALL
All patients receive induction therapy comprising intrathecal (IT) cytarabine on day 1; vincristine sulfate IV on days 1, 8, 15, and 22; dexamethasone orally (PO) or IV twice daily (BID) on days 1-28; pegaspargase IV over 1-2 hours on day 4; and IT methotrexate on days 8 and 29. Patients with DS also receive leucovorin calcium every 12 hours on days 10-11 and 21-32. Patients with Philadelphia chromosome-positive disease are eligible to transfer to COG-AALL0622 by day 15 of induction therapy and patients with high-risk (HR) or very high-risk (VHR) disease are eligible to transfer to a COG HR or VHR trial at the end of induction therapy. Patients with standard-risk disease with Down syndrome (DS) who have bone marrow minimal residual disease 0.01% are eligible to transfer to the DS stratum of the HR trial. Patients with induction failure (defined as M3 [> 25% lymphoblasts] on day 29) may be eligible for the COG VHR-acute lymphoblastic leukemia study.
125
9,229
72
9,229
1,776
9,229
EG001
B-LLy
Induction: same trt as B-ALL; Consolidation (4 wks): vincristine sulfate day 1; mercaptopurine days 1-28; IT methotrexate (MTX) days 1/8/15; leucovorin calcium days 3-4,10-11,17-18 Interim maintenance I (8 wks): vincristine sulfate and MTX 2-15 min days 1/11/21/31/41; IT MTX day 31; leucovorin calcium days 33-34 Delayed-intensification (8 wks): dexamethasone days 1-7 and 15-21; vincristine sulfate and doxorubicin hydrochloride on days 1/8/15; pegaspargase 1-2 hrs day 4; cyclophosphamide day 29; thioguanine days 29-42; cytarabine 29-32, 33-39; IT MTX days 1/29; and leucovorin calcium days 3-4, 31-32 Interim maintenance II (8 wks): vincristine sulfate and MTX days 1/11/21/31/41; IT MTX days 1/31; and leucovorin calcium days 3-4, 33/34 Maintenance: vincristine sulfate day 1; dexamethasone days 1-5; MTX weekly days 8-78; mercaptopurine days 1-84; and IT MTX day 1. Courses repeat every 4 wks for 2 yrs (from the start of IMI therapy).
2
48
0
48
30
48
EG002
B-ALL Average Risk
Consolidation (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34
16
3,122
16
3,122
1,037
3,122
EG003
Standard Risk With Down Syndrome
Consolidation (4 w): vincristine (VIN) d1; MP d1-28; IT methotrexate (MTX) d1/8/15; leucovorin (LV) d3-4/10-11/17-18 Interim maintenance I (8 wks): VIN & IV MTX d1/11/21/31/41; IT MTX d31; LV d36-34 Delayed-intensification (8 wks): Patients receive dexamethasone (DEX) d1-7/15-21; VIN & doxorubicin d1/8/15; pegaspargase d4; cyclophosphamide d29; thioguanine d 29-42; cytarabine d29-32/33-39; IT MTX d1/29; and LV d3-4/31-32 Interim maintenance II (8 wks): VIN & IV MTX d1/11/21/31/41; IT MTX d1/31; and LV d3-4/33-34 Maintenance: VIN d1; DEX d1-5; PO MTX wkly d8-78; MP d1-84; and IT MTX d1. Courses repeat every 12 wks for 2 years (timed from the start of interim maintenance I therapy).
11
224
9
224
191
224
EG004
B-ALL Low Risk Arm I (LR-M)
Consolidation (19 w): vincristine (VIN) day(d) 15/22/78/85; IV/IT methotrexate (MTX) d8/29/50/71/92/113; leucovorin (LV) d9-10/30-31/51-52/72-73/93-94/114-115; dexamethasone (DEX) d15-21/78-84; mercaptopurine (MP) d 1-133. Maint.: VIN d1/8; DEX d1-7; MTX* PO wkly d1-106; MP d 1-112. Repeat every 16 w until 2.5 yrs from dx. IT MTX d1/85 (course 1&4), d 57 (course 2&5), d29 (course 3&6). Course 7: VIN d1/8; DEX d 1-7; MTX PO wkly d8-64; and MP d1-70. *Patients do not receive MTX PO on d w/ IT MTX.
0
301
0
301
103
301
EG005
B-ALL Low Risk Arm II (LR-C)
Consolidation (4 w): VIN d1; MP d1-28; IT MTX d1/8/15 Interim Maint. I (8 w): VIN & IV MTX d1/11/21/31/41; IT MTX d31 Delayed-intensification (8 w): DEX d1-7/15-21; VIN & doxorubicin d1/8/15; pegaspargase d4; cyclophosphamide d29; thioguanine d 29-42; cytarabine d29-32/36-39; IT MTX d1/29 Interim Maint. II (8 w): VIN & IV MTX d1/11/21/31/41; IT MTX d1/31 Maint.: VIN d1; DEX d1-5; MTX PO wkly d22-78; MP d 1-84; IT MTX d1. Rpt every 12 w for 2 yrs:girls, 3 yrs:boys from start IM1
1
302
0
302
143
302
EG006
B-ALL Average Risk-Arm A
Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1+P8:W8-84; and IT MTX d 1
7
600
7
600
180
600
EG007
B-ALL Average Risk-Arm B
Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1
8
586
7
586
204
586
EG008
B-ALL Average Risk-Arm C
Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1
6
586
4
586
156
586
EG009
B-ALL Average Risk-Arm D
Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
7
592
3
592
152
592
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anemia
Blood and lymphatic system disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG0030 events0 affected224 at risk
EG0040 events0 affected301 at risk
EG0050 events0 affected302 at risk
EG0060 events0 affected600 at risk
EG0070 events0 affected586 at risk
EG0080 events0 affected586 at risk
EG0090 events0 affected592 at risk
Blood and lymphatic system disorders - Other, specify
Blood and lymphatic system disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Disseminated intravascular coagulation
Blood and lymphatic system disorders
CTCv4
Systematic Assessment
EG0002 events2 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
CTCv4
Systematic Assessment
EG0003 events3 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Cardiac arrest
Cardiac disorders
CTCv4
Systematic Assessment
EG0003 events3 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Heart failure
Cardiac disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Ventricular tachycardia
Cardiac disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Adrenal insufficiency
Endocrine disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Abdominal distension
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0002 events2 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Ascites
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0002 events2 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Colitis
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Colonic perforation
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0007 events7 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Constipation
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0002 events2 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Diarrhea
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Gastric hemorrhage
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Gastric perforation
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Gastrointestinal disorders - Other, specify
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Gastrointestinal pain
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Ileal hemorrhage
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Ileal perforation
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Ileal ulcer
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Ileus
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Mucositis oral
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Nausea
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Pancreatic necrosis
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0002 events2 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Pancreatitis
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0002 events2 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Small intestinal perforation
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Typhlitis
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0004 events4 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Vomiting
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0002 events2 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Death NOS
General disorders
CTCv4
Systematic Assessment
EG0007 events7 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0024 events4 affected3,122 at risk
EG003
Multi-organ failure
General disorders
CTCv4
Systematic Assessment
EG0003 events3 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0022 events2 affected3,122 at risk
EG003
Sudden death NOS
General disorders
CTCv4
Systematic Assessment
EG0002 events2 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Cholecystitis
Hepatobiliary disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Hepatic failure
Hepatobiliary disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Anaphylaxis
Immune system disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Immune system disorders - Other, specify
Immune system disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Abdominal infection
Infections and infestations
CTCv4
Systematic Assessment
EG0002 events2 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Catheter related infection
Infections and infestations
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Cecal infection
Infections and infestations
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Hepatitis viral
Infections and infestations
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Infections and infestations - Other, specify
Infections and infestations
CTCv4
Systematic Assessment
EG0004 events4 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Lung infection
Infections and infestations
CTCv4
Systematic Assessment
EG0005 events5 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Meningitis
Infections and infestations
CTCv4
Systematic Assessment
EG0003 events3 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Mucosal infection
Infections and infestations
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Periorbital infection
Infections and infestations
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Peritoneal infection
Infections and infestations
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Sepsis
Infections and infestations
CTCv4
Systematic Assessment
EG00023 events23 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0022 events2 affected3,122 at risk
EG003
Sinusitis
Infections and infestations
CTCv4
Systematic Assessment
EG0002 events2 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Skin infection
Infections and infestations
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Alanine aminotransferase increased
Investigations
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Aspartate aminotransferase increased
Investigations
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Blood bilirubin increased
Investigations
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Cholesterol high
Investigations
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Neutrophil count decreased
Investigations
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
White blood cell decreased
Investigations
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Acidosis
Metabolism and nutrition disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Anorexia
Metabolism and nutrition disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Hyperglycemia
Metabolism and nutrition disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Hyperkalemia
Metabolism and nutrition disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Hypertriglyceridemia
Metabolism and nutrition disorders
CTCv4
Systematic Assessment
EG0002 events2 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Hypoalbuminemia
Metabolism and nutrition disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Hypoglycemia
Metabolism and nutrition disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Hypophosphatemia
Metabolism and nutrition disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Muscle weakness lower limb
Musculoskeletal and connective tissue disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Myelodysplastic syndrome
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Treatment related secondary malignancy
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CTCv4
Systematic Assessment
EG0003 events3 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Depressed level of consciousness
Nervous system disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Dysarthria
Nervous system disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Edema cerebral
Nervous system disorders
CTCv4
Systematic Assessment
EG0002 events2 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Encephalopathy
Nervous system disorders
CTCv4
Systematic Assessment
EG0002 events2 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Headache
Nervous system disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Hydrocephalus
Nervous system disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Intracranial hemorrhage
Nervous system disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Nervous system disorders - Other, specify
Nervous system disorders
CTCv4
Systematic Assessment
EG0003 events3 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Reversible posterior leukoencephalopathy syndrome
Nervous system disorders
CTCv4
Systematic Assessment
EG0002 events2 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Seizure
Nervous system disorders
CTCv4
Systematic Assessment
EG0003 events3 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Stroke
Nervous system disorders
CTCv4
Systematic Assessment
EG0003 events3 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Personality change
Psychiatric disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Acute kidney injury
Renal and urinary disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Renal and urinary disorders - Other, specify
Renal and urinary disorders
CTCv4
Systematic Assessment
EG0002 events2 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Renal calculi
Renal and urinary disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Adult respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Apnea
Respiratory, thoracic and mediastinal disorders
CTCv4
Systematic Assessment
EG0002 events2 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Bronchopulmonary hemorrhage
Respiratory, thoracic and mediastinal disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Dyspnea
Respiratory, thoracic and mediastinal disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
CTCv4
Systematic Assessment
EG0003 events3 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
CTCv4
Systematic Assessment
EG0003 events3 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Pulmonary edema
Respiratory, thoracic and mediastinal disorders
CTCv4
Systematic Assessment
EG0002 events2 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
CTCv4
Systematic Assessment
EG0007 events7 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0025 events5 affected3,122 at risk
EG003
Sinus disorder
Respiratory, thoracic and mediastinal disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Toxic epidermal necrolysis
Skin and subcutaneous tissue disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Surgical and medical procedures - Other, specify
Surgical and medical procedures
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Hypertension
Vascular disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Hypotension
Vascular disorders
CTCv4
Systematic Assessment
EG0007 events7 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Thromboembolic event
Vascular disorders
CTCv4
Systematic Assessment
EG0003 events3 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Vasculitis
Vascular disorders
CTCv4
Systematic Assessment
EG0002 events2 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anemia
Blood and lymphatic system disorders
CTCv4
Systematic Assessment
EG00026 events26 affected9,229 at risk
EG0010 events0 affected48 at risk
EG00221 events19 affected3,122 at risk
EG0032 events2 affected224 at risk
EG0042 events2 affected301 at risk
EG0053 events3 affected302 at risk
EG0062 events2 affected600 at risk
EG0072 events2 affected586 at risk
EG0082 events2 affected586 at risk
EG0093 events3 affected592 at risk
Blood and lymphatic system disorders - Other, specify
Blood and lymphatic system disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0023 events3 affected3,122 at risk
EG003
Bone marrow hypocellular
Blood and lymphatic system disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Disseminated intravascular coagulation
Blood and lymphatic system disorders
CTCv4
Systematic Assessment
EG0003 events3 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
CTCv4
Systematic Assessment
EG000114 events114 affected9,229 at risk
EG0010 events0 affected48 at risk
EG002112 events101 affected3,122 at risk
EG003
Hemolytic uremic syndrome
Blood and lymphatic system disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Cardiac arrest
Cardiac disorders
CTCv4
Systematic Assessment
EG0006 events6 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Cardiac disorders - Other, specify
Cardiac disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Heart failure
Cardiac disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Sinus bradycardia
Cardiac disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Sinus tachycardia
Cardiac disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
CTCv4
Systematic Assessment
EG0002 events2 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Wolff-Parkinson-White syndrome
Cardiac disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Congenital, familial and genetic disorders - Other, specify
Congenital, familial and genetic disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Ear and labyrinth disorders - Other, specify
Ear and labyrinth disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Hearing impaired
Ear and labyrinth disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Adrenal insufficiency
Endocrine disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Cushingoid
Endocrine disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Endocrine disorders - Other, specify
Endocrine disorders
CTCv4
Systematic Assessment
EG0004 events4 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Conjunctivitis
Eye disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Eye disorders - Other, specify
Eye disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Optic nerve disorder
Eye disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Vitreous hemorrhage
Eye disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Abdominal distension
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0007 events7 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Abdominal pain
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0008 events8 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0022 events2 affected3,122 at risk
EG003
Anal hemorrhage
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Anal mucositis
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0023 events3 affected3,122 at risk
EG003
Anal necrosis
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Anal ulcer
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0002 events2 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Ascites
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0002 events2 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0022 events2 affected3,122 at risk
EG003
Cecal hemorrhage
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Colitis
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0006 events6 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0028 events7 affected3,122 at risk
EG003
Colonic hemorrhage
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Colonic obstruction
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Colonic perforation
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0006 events6 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Constipation
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG00013 events13 affected9,229 at risk
EG0011 events1 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Dental caries
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Diarrhea
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0008 events8 affected9,229 at risk
EG0010 events0 affected48 at risk
EG00212 events12 affected3,122 at risk
EG003
Duodenal perforation
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Dysphagia
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Enterocolitis
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0003 events3 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Gastric hemorrhage
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0002 events2 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Gastric necrosis
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Gastric perforation
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Gastritis
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Gastrointestinal disorders - Other, specify
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0003 events3 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Gastrointestinal pain
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Ileal obstruction
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Ileal perforation
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0004 events4 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Ileus
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG00034 events34 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0024 events4 affected3,122 at risk
EG003
Jejunal obstruction
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Jejunal perforation
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0002 events2 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Lower gastrointestinal hemorrhage
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0003 events3 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Malabsorption
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Mucositis oral
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG00070 events70 affected9,229 at risk
EG00117 events16 affected48 at risk
EG002374 events354 affected3,122 at risk
EG003
Nausea
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0022 events2 affected3,122 at risk
EG003
Oral pain
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0011 events1 affected48 at risk
EG0023 events3 affected3,122 at risk
EG003
Pancreatic necrosis
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Pancreatitis
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG00090 events90 affected9,229 at risk
EG0010 events0 affected48 at risk
EG00215 events15 affected3,122 at risk
EG003
Proctitis
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Rectal mucositis
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0023 events3 affected3,122 at risk
EG003
Rectal obstruction
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Rectal perforation
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0022 events2 affected3,122 at risk
EG003
Small intestinal mucositis
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Small intestinal perforation
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0002 events2 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Typhlitis
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG00015 events15 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0023 events3 affected3,122 at risk
EG003
Vomiting
Gastrointestinal disorders
CTCv4
Systematic Assessment
EG0003 events3 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0029 events8 affected3,122 at risk
EG003
Fatigue
General disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Fever
General disorders
CTCv4
Systematic Assessment
EG00018 events18 affected9,229 at risk
EG0010 events0 affected48 at risk
EG00243 events36 affected3,122 at risk
EG003
Flu like symptoms
General disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Gait disturbance
General disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Infusion related reaction
General disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0022 events2 affected3,122 at risk
EG003
Injection site reaction
General disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Irritability
General disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0022 events2 affected3,122 at risk
EG003
Localized edema
General disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Malaise
General disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Multi-organ failure
General disorders
CTCv4
Systematic Assessment
EG0002 events2 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Pain
General disorders
CTCv4
Systematic Assessment
EG0008 events8 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0025 events5 affected3,122 at risk
EG003
Cholecystitis
Hepatobiliary disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Gallbladder pain
Hepatobiliary disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Hepatic failure
Hepatobiliary disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Hepatobiliary disorders - Other, specify
Hepatobiliary disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0027 events7 affected3,122 at risk
EG003
Portal hypertension
Hepatobiliary disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Portal vein thrombosis
Hepatobiliary disorders
CTCv4
Systematic Assessment
EG0002 events2 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Allergic reaction
Immune system disorders
CTCv4
Systematic Assessment
EG00022 events22 affected9,229 at risk
EG0011 events1 affected48 at risk
EG00250 events50 affected3,122 at risk
EG003
Anaphylaxis
Immune system disorders
CTCv4
Systematic Assessment
EG0009 events9 affected9,229 at risk
EG0012 events2 affected48 at risk
EG00221 events21 affected3,122 at risk
EG003
Immune system disorders - Other, specify
Immune system disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Abdominal infection
Infections and infestations
CTCv4
Systematic Assessment
EG0002 events2 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Anorectal infection
Infections and infestations
CTCv4
Systematic Assessment
EG0003 events3 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Appendicitis
Infections and infestations
CTCv4
Systematic Assessment
EG0002 events2 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Appendicitis perforated
Infections and infestations
CTCv4
Systematic Assessment
EG0003 events3 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Bladder infection
Infections and infestations
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Bone infection
Infections and infestations
CTCv4
Systematic Assessment
EG0002 events2 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Bronchial infection
Infections and infestations
CTCv4
Systematic Assessment
EG0002 events2 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0023 events2 affected3,122 at risk
EG003
Catheter related infection
Infections and infestations
CTCv4
Systematic Assessment
EG00044 events44 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0026 events6 affected3,122 at risk
EG003
Cecal infection
Infections and infestations
CTCv4
Systematic Assessment
EG0002 events2 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Device related infection
Infections and infestations
CTCv4
Systematic Assessment
EG0005 events5 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Encephalitis infection
Infections and infestations
CTCv4
Systematic Assessment
EG0003 events3 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Endocarditis infective
Infections and infestations
CTCv4
Systematic Assessment
EG0002 events2 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Enterocolitis infectious
Infections and infestations
CTCv4
Systematic Assessment
EG0007 events7 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0026 events6 affected3,122 at risk
EG003
Esophageal infection
Infections and infestations
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0011 events1 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Eye infection
Infections and infestations
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Gum infection
Infections and infestations
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Hepatic infection
Infections and infestations
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Hepatitis viral
Infections and infestations
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Infections and infestations - Other, specify
Infections and infestations
CTCv4
Systematic Assessment
EG000125 events122 affected9,229 at risk
EG0012 events2 affected48 at risk
EG00250 events48 affected3,122 at risk
EG003
Infective myositis
Infections and infestations
CTCv4
Systematic Assessment
EG0002 events2 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Kidney infection
Infections and infestations
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Laryngitis
Infections and infestations
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Lip infection
Infections and infestations
CTCv4
Systematic Assessment
EG0003 events3 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Lung infection
Infections and infestations
CTCv4
Systematic Assessment
EG00019 events19 affected9,229 at risk
EG0011 events1 affected48 at risk
EG00213 events13 affected3,122 at risk
EG003
Lymph gland infection
Infections and infestations
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Mediastinal infection
Infections and infestations
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Meningitis
Infections and infestations
CTCv4
Systematic Assessment
EG0002 events2 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Mucosal infection
Infections and infestations
CTCv4
Systematic Assessment
EG0005 events5 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0023 events3 affected3,122 at risk
EG003
Otitis externa
Infections and infestations
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Otitis media
Infections and infestations
CTCv4
Systematic Assessment
EG0003 events3 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0026 events6 affected3,122 at risk
EG003
Pancreas infection
Infections and infestations
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Papulopustular rash
Infections and infestations
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Paronychia
Infections and infestations
CTCv4
Systematic Assessment
EG0002 events2 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Periorbital infection
Infections and infestations
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Peripheral nerve infection
Infections and infestations
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Peritoneal infection
Infections and infestations
CTCv4
Systematic Assessment
EG0004 events4 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Pharyngitis
Infections and infestations
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Rash pustular
Infections and infestations
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Scrotal infection
Infections and infestations
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Sepsis
Infections and infestations
CTCv4
Systematic Assessment
EG000100 events100 affected9,229 at risk
EG0012 events2 affected48 at risk
EG00222 events22 affected3,122 at risk
EG003
Sinusitis
Infections and infestations
CTCv4
Systematic Assessment
EG0004 events4 affected9,229 at risk
EG0012 events1 affected48 at risk
EG0025 events5 affected3,122 at risk
EG003
Skin infection
Infections and infestations
CTCv4
Systematic Assessment
EG00019 events19 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0024 events3 affected3,122 at risk
EG003
Small intestine infection
Infections and infestations
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Soft tissue infection
Infections and infestations
CTCv4
Systematic Assessment
EG0005 events5 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Stoma site infection
Infections and infestations
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Tooth infection
Infections and infestations
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Tracheitis
Infections and infestations
CTCv4
Systematic Assessment
EG0002 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Upper respiratory infection
Infections and infestations
CTCv4
Systematic Assessment
EG00012 events12 affected9,229 at risk
EG0010 events0 affected48 at risk
EG00224 events23 affected3,122 at risk
EG003
Urethral infection
Infections and infestations
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Urinary tract infection
Infections and infestations
CTCv4
Systematic Assessment
EG0008 events8 affected9,229 at risk
EG0010 events0 affected48 at risk
EG00211 events10 affected3,122 at risk
EG003
Vaginal infection
Infections and infestations
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Wound infection
Infections and infestations
CTCv4
Systematic Assessment
EG00014 events14 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Fall
Injury, poisoning and procedural complications
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Fracture
Injury, poisoning and procedural complications
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Injury, poisoning and procedural complications - Other, specify
Injury, poisoning and procedural complications
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Tracheal obstruction
Injury, poisoning and procedural complications
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Vascular access complication
Injury, poisoning and procedural complications
CTCv4
Systematic Assessment
EG00016 events16 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0025 events5 affected3,122 at risk
EG003
Wound dehiscence
Injury, poisoning and procedural complications
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
CTCv4
Systematic Assessment
EG0002 events2 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Alanine aminotransferase increased
Investigations
CTCv4
Systematic Assessment
EG000195 events195 affected9,229 at risk
EG0017 events6 affected48 at risk
EG002160 events139 affected3,122 at risk
EG003
Alkaline phosphatase increased
Investigations
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0028 events8 affected3,122 at risk
EG003
Aspartate aminotransferase increased
Investigations
CTCv4
Systematic Assessment
EG00073 events72 affected9,229 at risk
EG0013 events3 affected48 at risk
EG00223 events22 affected3,122 at risk
EG003
Blood bilirubin increased
Investigations
CTCv4
Systematic Assessment
EG000111 events111 affected9,229 at risk
EG00110 events9 affected48 at risk
EG0029 events9 affected3,122 at risk
EG003
Cholesterol high
Investigations
CTCv4
Systematic Assessment
EG0006 events6 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Creatinine increased
Investigations
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Fibrinogen decreased
Investigations
CTCv4
Systematic Assessment
EG00055 events55 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0026 events6 affected3,122 at risk
EG003
GGT increased
Investigations
CTCv4
Systematic Assessment
EG00034 events34 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Investigations - Other, specify
Investigations
CTCv4
Systematic Assessment
EG0003 events3 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0025 events5 affected3,122 at risk
EG003
Lipase increased
Investigations
CTCv4
Systematic Assessment
EG00040 events39 affected9,229 at risk
EG0010 events0 affected48 at risk
EG00210 events10 affected3,122 at risk
EG003
Lymphocyte count decreased
Investigations
CTCv4
Systematic Assessment
EG00013 events13 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0026 events6 affected3,122 at risk
EG003
Neutrophil count decreased
Investigations
CTCv4
Systematic Assessment
EG000339 events333 affected9,229 at risk
EG0011 events1 affected48 at risk
EG002259 events201 affected3,122 at risk
EG003
Platelet count decreased
Investigations
CTCv4
Systematic Assessment
EG000161 events161 affected9,229 at risk
EG0011 events1 affected48 at risk
EG00240 events38 affected3,122 at risk
EG003
Serum amylase increased
Investigations
CTCv4
Systematic Assessment
EG00014 events13 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0026 events6 affected3,122 at risk
EG003
Weight gain
Investigations
CTCv4
Systematic Assessment
EG0002 events2 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Weight loss
Investigations
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0022 events2 affected3,122 at risk
EG003
White blood cell decreased
Investigations
CTCv4
Systematic Assessment
EG000142 events141 affected9,229 at risk
EG0010 events0 affected48 at risk
EG00244 events41 affected3,122 at risk
EG003
Acidosis
Metabolism and nutrition disorders
CTCv4
Systematic Assessment
EG0002 events2 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Alkalosis
Metabolism and nutrition disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Anorexia
Metabolism and nutrition disorders
CTCv4
Systematic Assessment
EG0003 events3 affected9,229 at risk
EG0011 events1 affected48 at risk
EG0024 events4 affected3,122 at risk
EG003
Dehydration
Metabolism and nutrition disorders
CTCv4
Systematic Assessment
EG0006 events6 affected9,229 at risk
EG0011 events1 affected48 at risk
EG00213 events13 affected3,122 at risk
EG003
Glucose intolerance
Metabolism and nutrition disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Hypercalcemia
Metabolism and nutrition disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Hyperglycemia
Metabolism and nutrition disorders
CTCv4
Systematic Assessment
EG000147 events147 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0026 events5 affected3,122 at risk
EG003
Hyperkalemia
Metabolism and nutrition disorders
CTCv4
Systematic Assessment
EG00010 events10 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0023 events3 affected3,122 at risk
EG003
Hypernatremia
Metabolism and nutrition disorders
CTCv4
Systematic Assessment
EG0005 events5 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0022 events2 affected3,122 at risk
EG003
Hypertriglyceridemia
Metabolism and nutrition disorders
CTCv4
Systematic Assessment
EG00024 events24 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Hyperuricemia
Metabolism and nutrition disorders
CTCv4
Systematic Assessment
EG0008 events8 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Hypoalbuminemia
Metabolism and nutrition disorders
CTCv4
Systematic Assessment
EG0008 events8 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0023 events3 affected3,122 at risk
EG003
Hypocalcemia
Metabolism and nutrition disorders
CTCv4
Systematic Assessment
EG00041 events41 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0027 events7 affected3,122 at risk
EG003
Hypoglycemia
Metabolism and nutrition disorders
CTCv4
Systematic Assessment
EG0004 events4 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Hypokalemia
Metabolism and nutrition disorders
CTCv4
Systematic Assessment
EG00079 events79 affected9,229 at risk
EG0011 events1 affected48 at risk
EG00240 events34 affected3,122 at risk
EG003
Hypomagnesemia
Metabolism and nutrition disorders
CTCv4
Systematic Assessment
EG0004 events4 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Hyponatremia
Metabolism and nutrition disorders
CTCv4
Systematic Assessment
EG00022 events22 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0023 events3 affected3,122 at risk
EG003
Hypophosphatemia
Metabolism and nutrition disorders
CTCv4
Systematic Assessment
EG0004 events4 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Metabolism and nutrition disorders - Other, specify
Metabolism and nutrition disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Tumor lysis syndrome
Metabolism and nutrition disorders
CTCv4
Systematic Assessment
EG00010 events10 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Avascular necrosis
Musculoskeletal and connective tissue disorders
CTCv4
Systematic Assessment
EG0006 events6 affected9,229 at risk
EG0011 events1 affected48 at risk
EG0025 events5 affected3,122 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Generalized muscle weakness
Musculoskeletal and connective tissue disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Muscle weakness left-sided
Musculoskeletal and connective tissue disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0022 events2 affected3,122 at risk
EG003
Muscle weakness lower limb
Musculoskeletal and connective tissue disorders
CTCv4
Systematic Assessment
EG0004 events4 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0022 events2 affected3,122 at risk
EG003
Muscle weakness right-sided
Musculoskeletal and connective tissue disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0022 events2 affected3,122 at risk
EG003
Musculoskeletal and connective tissue disorder - Other, specify
Musculoskeletal and connective tissue disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Myositis
Musculoskeletal and connective tissue disorders
CTCv4
Systematic Assessment
EG0002 events2 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Osteoporosis
Musculoskeletal and connective tissue disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
CTCv4
Systematic Assessment
EG0005 events5 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0022 events2 affected3,122 at risk
EG003
Soft tissue necrosis lower limb
Musculoskeletal and connective tissue disorders
CTCv4
Systematic Assessment
EG0002 events2 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Soft tissue necrosis upper limb
Musculoskeletal and connective tissue disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Akathisia
Nervous system disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Arachnoiditis
Nervous system disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Central nervous system necrosis
Nervous system disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Cerebrospinal fluid leakage
Nervous system disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Depressed level of consciousness
Nervous system disorders
CTCv4
Systematic Assessment
EG0004 events4 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Dysarthria
Nervous system disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Dysphasia
Nervous system disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Encephalopathy
Nervous system disorders
CTCv4
Systematic Assessment
EG00013 events13 affected9,229 at risk
EG0011 events1 affected48 at risk
EG0027 events7 affected3,122 at risk
EG003
Facial muscle weakness
Nervous system disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Headache
Nervous system disorders
CTCv4
Systematic Assessment
EG0003 events3 affected9,229 at risk
EG0011 events1 affected48 at risk
EG0026 events5 affected3,122 at risk
EG003
Hydrocephalus
Nervous system disorders
CTCv4
Systematic Assessment
EG0003 events3 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Intracranial hemorrhage
Nervous system disorders
CTCv4
Systematic Assessment
EG00017 events17 affected9,229 at risk
EG0011 events1 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Ischemia cerebrovascular
Nervous system disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Leukoencephalopathy
Nervous system disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0011 events1 affected48 at risk
EG0024 events4 affected3,122 at risk
EG003
Movements involuntary
Nervous system disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Nervous system disorders - Other, specify
Nervous system disorders
CTCv4
Systematic Assessment
EG0006 events5 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0025 events5 affected3,122 at risk
EG003
Neuralgia
Nervous system disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Oculomotor nerve disorder
Nervous system disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Paresthesia
Nervous system disorders
CTCv4
Systematic Assessment
EG0002 events2 affected9,229 at risk
EG0011 events1 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Peripheral motor neuropathy
Nervous system disorders
CTCv4
Systematic Assessment
EG000175 events175 affected9,229 at risk
EG0012 events2 affected48 at risk
EG002109 events98 affected3,122 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
CTCv4
Systematic Assessment
EG000151 events151 affected9,229 at risk
EG0014 events3 affected48 at risk
EG00283 events69 affected3,122 at risk
EG003
Recurrent laryngeal nerve palsy
Nervous system disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Reversible posterior leukoencephalopathy syndrome
Nervous system disorders
CTCv4
Systematic Assessment
EG00010 events10 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0022 events2 affected3,122 at risk
EG003
Seizure
Nervous system disorders
CTCv4
Systematic Assessment
EG00069 events69 affected9,229 at risk
EG0014 events4 affected48 at risk
EG00259 events52 affected3,122 at risk
EG003
Stroke
Nervous system disorders
CTCv4
Systematic Assessment
EG0005 events5 affected9,229 at risk
EG0011 events1 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Syncope
Nervous system disorders
CTCv4
Systematic Assessment
EG0002 events2 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Transient ischemic attacks
Nervous system disorders
CTCv4
Systematic Assessment
EG0002 events2 affected9,229 at risk
EG0013 events3 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Vasovagal reaction
Nervous system disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Agitation
Psychiatric disorders
CTCv4
Systematic Assessment
EG0002 events2 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Personality change
Psychiatric disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Psychosis
Psychiatric disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0011 events1 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Acute kidney injury
Renal and urinary disorders
CTCv4
Systematic Assessment
EG00016 events16 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0024 events4 affected3,122 at risk
EG003
Proteinuria
Renal and urinary disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Renal and urinary disorders - Other, specify
Renal and urinary disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Renal calculi
Renal and urinary disorders
CTCv4
Systematic Assessment
EG00013 events13 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Urinary frequency
Renal and urinary disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Urinary incontinence
Renal and urinary disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
CTCv4
Systematic Assessment
EG0003 events3 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Urinary tract pain
Renal and urinary disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Urinary urgency
Renal and urinary disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Reproductive system and breast disorders - Other, specify
Reproductive system and breast disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Scrotal pain
Reproductive system and breast disorders
CTCv4
Systematic Assessment
EG0002 events2 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Adult respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Apnea
Respiratory, thoracic and mediastinal disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Bronchial stricture
Respiratory, thoracic and mediastinal disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Dyspnea
Respiratory, thoracic and mediastinal disorders
CTCv4
Systematic Assessment
EG0003 events3 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Hoarseness
Respiratory, thoracic and mediastinal disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
CTCv4
Systematic Assessment
EG00011 events11 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0023 events3 affected3,122 at risk
EG003
Laryngeal edema
Respiratory, thoracic and mediastinal disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
CTCv4
Systematic Assessment
EG0006 events6 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
CTCv4
Systematic Assessment
EG0002 events2 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0022 events2 affected3,122 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
CTCv4
Systematic Assessment
EG0004 events4 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Pulmonary edema
Respiratory, thoracic and mediastinal disorders
CTCv4
Systematic Assessment
EG0003 events3 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Pulmonary hypertension
Respiratory, thoracic and mediastinal disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
CTCv4
Systematic Assessment
EG00019 events19 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0024 events4 affected3,122 at risk
EG003
Respiratory, thoracic and mediastinal disorders - Other, specify
Respiratory, thoracic and mediastinal disorders
CTCv4
Systematic Assessment
EG0003 events3 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Stridor
Respiratory, thoracic and mediastinal disorders
CTCv4
Systematic Assessment
EG0003 events3 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Tracheal stenosis
Respiratory, thoracic and mediastinal disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Erythema multiforme
Skin and subcutaneous tissue disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Palmar-plantar erythrodysesthesia syndrome
Skin and subcutaneous tissue disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Periorbital edema
Skin and subcutaneous tissue disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Photosensitivity
Skin and subcutaneous tissue disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Rash acneiform
Skin and subcutaneous tissue disorders
CTCv4
Systematic Assessment
EG0000 events0 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0020 events0 affected3,122 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
CTCv4
Systematic Assessment
EG0001 events1 affected9,229 at risk
EG0010 events0 affected48 at risk
EG0021 events1 affected3,122 at risk
EG003
Skin and subcutaneous tissue disorders - Other, specify
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D025063
Chromosome Disorders
D030342
Genetic Diseases, Inborn
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D003520
Cyclophosphamide
D003561
Cytarabine
D003907
Dexamethasone
D002123
Calcium Dobesilate
C059464
auricularum
C018038
dexamethasone acetate
C004180
dexamethasone 21-phosphate
D004317
Doxorubicin
D002955
Leucovorin
D015122
Mercaptopurine
C488629
azathiopurine
D008727
Methotrexate
C015342
merphos
C042705
pegaspargase
D013866
Thioguanine
D014750
Vincristine
Ancestor Terms
ID
Term
D010752
Phosphoramide Mustards
D009588
Nitrogen Mustard Compounds
D009150
Mustard Compounds
D006846
Hydrocarbons, Halogenated
D006838
Hydrocarbons
D009930
Organic Chemicals
D063088
Phosphoramides
D009943
Organophosphorus Compounds
D003562
Cytidine
D011741
Pyrimidine Nucleosides
D011743
Pyrimidines
D006573
Heterocyclic Compounds, 1-Ring
D006571
Heterocyclic Compounds
D001087
Arabinonucleosides
D009705
Nucleosides
D009706
Nucleic Acids, Nucleotides, and Nucleosides
D011246
Pregnadienetriols
D011245
Pregnadienes
D011278
Pregnanes
D013256
Steroids
D000072473
Fused-Ring Compounds
D011083
Polycyclic Compounds
D013259
Steroids, Fluorinated
D001557
Benzenesulfonates
D001555
Benzene Derivatives
D006841
Hydrocarbons, Aromatic
D006844
Hydrocarbons, Cyclic
D001190
Arylsulfonates
D017739
Arylsulfonic Acids
D013451
Sulfonic Acids
D013456
Sulfur Acids
D013457
Sulfur Compounds
D003630
Daunorubicin
D018943
Anthracyclines
D009279
Naphthacenes
D011084
Polycyclic Aromatic Hydrocarbons
D000617
Aminoglycosides
D006027
Glycosides
D002241
Carbohydrates
D005575
Formyltetrahydrofolates
D013763
Tetrahydrofolates
D005492
Folic Acid
D011622
Pterins
D011621
Pteridines
D006574
Heterocyclic Compounds, 2-Ring
D000072471
Heterocyclic Compounds, Fused-Ring
D003067
Coenzymes
D045762
Enzymes and Coenzymes
D013438
Sulfhydryl Compounds
D011687
Purines
D000630
Aminopterin
D014748
Vinca Alkaloids
D046948
Secologanin Tryptamine Alkaloids
D026121
Indole Alkaloids
D000470
Alkaloids
D007211
Indoles
D054836
Indolizidines
D007212
Indolizines
Browse Leaves
Not provided
Browse Branches
Not provided
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FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
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FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
296 subjects
FG005296 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
5 subjects
FG0056 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Death
FG0000 subjects
FG0010 subjects
FG0028 subjects
FG0034 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Physician Decision
FG0000 subjects
FG0012 subjects
FG00235 subjects
FG0037 subjects
FG0045 subjects
FG0053 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0025 subjects
FG0032 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Refusal
FG0000 subjects
FG0012 subjects
FG002694 subjects
FG0034 subjects
FG0040 subjects
FG0053 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Inevaluable
FG0000 subjects
FG0010 subjects
FG0026 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
CR failure at the end of consolidation
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Progressive disease
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Relapse
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
287 subjects
FG005284 subjects
FG006574 subjects
FG007540 subjects
FG008540 subjects
FG009555 subjects
9 subjects
FG00512 subjects
FG00626 subjects
FG00746 subjects
FG00846 subjects
FG00937 subjects
0 subjects
FG0040 subjects
FG0051 subjects
FG0061 subjects
FG0073 subjects
FG0083 subjects
FG0090 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0062 subjects
FG0072 subjects
FG0082 subjects
FG0092 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0071 subjects
FG0081 subjects
FG0090 subjects
Physician Decision
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0035 subjects
FG0049 subjects
FG0054 subjects
FG0068 subjects
FG0078 subjects
FG00810 subjects
FG00917 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0062 subjects
FG0071 subjects
FG0084 subjects
FG0091 subjects
Refusal
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0032 subjects
FG0040 subjects
FG0054 subjects
FG0065 subjects
FG00717 subjects
FG00813 subjects
FG0096 subjects
second malignant neoplasm
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
Inevaluable
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0061 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
Enrollment onto another COG Protocol
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
Relapse
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG0040 subjects
FG0051 subjects
FG0066 subjects
FG00713 subjects
FG00811 subjects
FG00911 subjects
Still on therapy
FG0000 subjects
FG0018 subjects
FG0020 subjects
FG00329 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
BG0000
BG0011
BG0021
>=65 years
BG0000
BG0010
BG0020
4.59
± 2.17
4321
Male
BG0005004
BG00125
BG0025029
2147
Not Hispanic or Latino
BG0006726
BG00135
BG0026761
Unknown or Not Reported
BG000440
BG0012
BG002442
94
Asian
BG000430
BG0011
BG002431
Native Hawaiian or Other Pacific Islander
BG00048
BG0010
BG00248
Black or African American
BG000501
BG0011
BG002502
White
BG0006857
BG00140
BG0026897
More than one race
BG00060
BG0011
BG00261
Unknown or Not Reported
BG0001308
BG0019
BG0021317
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
Units
Counts
Participants
OG0001186
OG0011178
Title
Denominators
Categories
Title
Measurements
OG00094.10(92.16 to 96.04)
OG00195.13(93.35 to 96.91)
Units
Counts
Participants
OG000301
OG001302
Title
Denominators
Categories
Title
Measurements
OG00098.75(97.14 to 100.00)
OG00198.50(96.75 to 100.00)
224
Title
Denominators
Categories
Title
Measurements
OG00089.77(83.60 to 95.94)
OG00039
Title
Denominators
Categories
Title
Measurements
OG00089.7(80.2 to 99.3)
OG00048
Title
Denominators
Categories
Title
Measurements
OG00094.54(78.17 to 100.00)
OG00048
Title
Denominators
Categories
Title
Measurements
OG00093.97(76.88 to 100.00)
OG000379
Title
Denominators
Categories
Title
Measurements
OG000-1.21± 1.14
OG000242
Title
Denominators
Categories
Title
Measurements
OG000-0.86± 1.10
OG000221
Title
Denominators
Categories
Title
Measurements
OG000-0.84± 1.11
Participants
OG000209
Title
Denominators
Categories
Title
Measurements
OG000-0.74± 1.10
OG00080
Title
Denominators
Categories
Title
Measurements
OG000-0.62± 1.26
OG000379
Title
Denominators
Categories
Title
Measurements
OG000-1.44± 1.10
OG000242
Title
Denominators
Categories
Title
Measurements
OG000-0.59± 1.02
OG000221
Title
Denominators
Categories
Title
Measurements
OG000-0.63± 1.06
OG000209
Title
Denominators
Categories
Title
Measurements
OG000-0.66± 1.15
OG00080
Title
Denominators
Categories
Title
Measurements
OG000-0.67± 1.23
OG0000
OG0000
OG0000
OG0000
OG0000
OG000379
Title
Denominators
Categories
Title
Measurements
OG000-0.42± 0.84
OG000242
Title
Denominators
Categories
Title
Measurements
OG000-0.19± 0.92
OG000221
Title
Denominators
Categories
Title
Measurements
OG000-0.20± 0.94
Participants
OG000209
Title
Denominators
Categories
Title
Measurements
OG000-0.30± 0.97
OG00080
Title
Denominators
Categories
Title
Measurements
OG000-0.40± 1.17
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
Units
Counts
Participants
OG000122
OG00199
Title
Denominators
Categories
Title
Measurements
OG000-0.80± 1.11
OG001-0.89± 1.13
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
Units
Counts
Participants
OG000111
OG00198
Title
Denominators
Categories
Title
Measurements
OG000-0.72± 1.10
OG001-0.77± 1.11
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
Units
Counts
Participants
OG00043
OG00137
Title
Denominators
Categories
Title
Measurements
OG000-0.71± 1.45
OG001-0.51± 1.00
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
Units
Counts
Participants
OG000122
OG00199
Title
Denominators
Categories
Title
Measurements
OG000-0.62± 1.01
OG001-0.64± 1.11
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
Units
Counts
Participants
OG000111
OG00198
Title
Denominators
Categories
Title
Measurements
OG000-0.64± 1.11
OG001-0.67± 1.19
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
Units
Counts
Participants
OG00043
OG00137
Title
Denominators
Categories
Title
Measurements
OG000-0.85± 1.30
OG001-0.47± 1.13
Units
Counts
Participants
OG0000
OG0010
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
Units
Counts
Participants
OG0000
OG0010
Units
Counts
Participants
OG0000
OG0010
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
Units
Counts
Participants
OG000122
OG00199
Title
Denominators
Categories
Title
Measurements
OG000-0.16± 0.85
OG001-0.25± 1.03
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
Units
Counts
Participants
OG000111
OG00198
Title
Denominators
Categories
Title
Measurements
OG000-0.27± 0.95
OG001-0.34± 1.00
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
Units
Counts
Participants
OG00043
OG00137
Title
Denominators
Categories
Title
Measurements
OG000-0.46± 1.20
OG001-0.33± 1.15
OG00090
Title
Denominators
Categories
Title
Measurements
OG000-0.87± 1.67
OG00089
Title
Denominators
Categories
Title
Measurements
OG000-0.84± 1.85
OG00089
Title
Denominators
Categories
Title
Measurements
OG000-0.39± 2.10
OG00088
Title
Denominators
Categories
Title
Measurements
OG000-0.36± 1.97
Participants
OG00059
Title
Denominators
Categories
Title
Measurements
OG000-0.27± 2.06
Participants
OG00058
Title
Denominators
Categories
Title
Measurements
OG000-0.28± 2.00
OG00035
Title
Denominators
Categories
Title
Measurements
OG000-1.12± 2.27
OG00035
Title
Denominators
Categories
Title
Measurements
OG000-1.19± 2.14
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayedintensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int.
maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
Units
Counts
Participants
OG00035
OG00140
Title
Denominators
Categories
Title
Measurements
OG000-1.12± 2.27
OG001-0.02± 3.01
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayedintensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int.
maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1