Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
Official Title
Standard Risk B-precursor Acute Lymphoblastic Leukemia (ALL)
Acronym
Not provided
Organization
Children's Oncology GroupNETWORK
Status Module
Record Verification Date
Apr 2021
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 11, 2005Actual
Primary Completion Date
Dec 30, 2013Actual
Completion Date
Mar 31, 2021Actual
First Submitted Date
Feb 7, 2005
First Submission Date that Met QC Criteria
Feb 7, 2005
First Posted Date
Feb 8, 2005Estimated
Results Waived
Not provided
Results First Submitted Date
Jun 28, 2016
Results First Submitted that Met QC Criteria
Jul 9, 2018
Results First Posted Date
Jul 11, 2018Actual
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
Jun 11, 2021
Last Update Posted Date
Jun 14, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Children's Oncology GroupNETWORK
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
This randomized phase III trial is studying different combination chemotherapy regimens and comparing how well they work in treating patients with newly diagnosed acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
Detailed Description
PRIMARY OBJECTIVES:
I. To determine whether the substitution of three intensified phases of post-Induction treatment for standard phases will improve the event free survival (EFS) of children with SR-average acute lymphoblastic leukemia (ALL).
II. Determine whether the substitution of intensified Consolidation for standard Consolidation will improve the EFS of children with SR-average ALL.
III. To determine whether the addition of four doses of percutaneous endoscopic gastrostomy (PEG) asparaginase, given once every three weeks during Consolidation and Interim Maintenance phases, will improve the EFS for children with SR-low ALL.
SECONDARY OBJECTIVES:
I. Identify potentially modifiable factors associated with impaired health related quality of life (HRQOL) at different periods of therapy in the patients who are SR-average enrolled on the standard risk ALL study.
II. Determine the critical time periods when future intervention studies to mitigate adverse HRQOL outcomes should occur.
III. Correlate day 29 minimal residual disease (MRD) with EFS and overall survival (OS) of patients treated with these regimens.
IV. Correlate early marrow response with day 29 MRD status. V. To improve outcome by identifying additional high risk patients by Day 29 MRD for treatment with fully augmented Berlin-Frankfurt-Munster (BFM).
VI. To examine the relative contributions of genetic factors and early treatment response to outcome by comparing the outcome of patients with and without TEL-AML1 fusion or triple trisomy and low levels of MRD at end Induction who are treated with identical therapy on the standard arms of the SR-low and SR-average trials.
OUTLINE: This is a 2-part, partially randomized, multicenter study. Patients are stratified according to early response to study induction therapy (rapid early response [standard risk (SR)-low or SR-average acute lymphoblastic leukemia (ALL)] vs slow early response [SR-high ALL]). After completion of induction therapy but before proceeding to part II therapy, patients are assigned to 1 of 3 groups based on stratification.
PART I:
INDUCTION THERAPY: All patients receive cytarabine intrathecally (IT) on day 1; vincristine IV on days 1, 8, 15, and 22; dexamethasone IV or orally (PO) twice daily (BID) on days 1-28; pegaspargase intramuscularly (IM) (may give IV over 1 to 2 hours) on day 4, 5, or 6; and methotrexate IT on days 8 and 29 (and days 15 and 22 for patients with CNS3 disease). Patients with Down syndrome (DS) receive leucovorin calcium PO at 48 and 60 hours after each dose of methotrexate IT. Patients are assessed for response on day 29. Patients with M1 bone marrow AND minimal residual disease (MRD) < 0.1% OR MRD >= 0.1% and < 1% proceed to therapy in part II. Patients with M2 bone marrow OR M1 bone marrow AND MRD >= 1% proceed to extended induction therapy. Patients with M3 bone marrow are removed from the study.
EXTENDED INDUCTION THERAPY: Patients receive dexamethasone IV or PO BID on days 1-14; vincristine IV on days 1 and 8; pegaspargase IM on day 4, 5, or 6; and daunorubicin hydrochloride IV over 15 minutes to 2 hours on day 1. Patients with M1 bone marrow and MRD < 1% after extended induction therapy proceed to therapy in part II. Patients with M2 or M3 bone marrow after extended induction therapy are removed from the study.
PART II:
GROUP 1 (SR-low ALL): Patients are randomized to 1 of 2 treatment arms.
ARM I:
STANDARD CONSOLIDATION THERAPY: Patients receive vincristine IV on day 1; mercaptopurine PO on days 1-28; and methotrexate IT on days 1, 8, and 15. Patients with Down syndrome (DS) receive leucovorin calcium (PO) at 48 and 60 hours after each dose of methotrexate IT.
STANDARD INTERIM MAINTENANCE THERAPY: Patients receive vincristine IV on days 1 and 29; dexamethasone IV or PO BID on days 1-5 and 29-33; mercaptopurine PO on days 1-50; methotrexate PO on days 1, 8, 15, 22, 29, 36, 43, and 50; and methotrexate IT on day 29. Patients with DS receive leucovorin calcium PO at 48 and 60 hours after each dose of methotrexate IT.
STANDARD DELAYED INTENSIFICATION (DI) THERAPY: Patients receive vincristine IV on days 1, 8, and 15; dexamethasone IV or PO BID on days 1-21; doxorubicin hydrochloride IV over 15 minutes to 2 hours on days 1, 8, and 15; pegaspargase IM on day 4, 5, or 6; cyclophosphamide IV over 30 minutes on day 29; cytarabine IV or subcutaneously (SC) on days 29-32 and 36-39; thioguanine PO on days 29-42; and methotrexate IT on days 1 and 29. Patients with DS receive dexamethasone IV or PO BID on days 1-7 and 15-21 and leucovorin calcium PO at 48 and 60 hours after each dose of methotrexate IT.
ARM II:
EXPERIMENTAL CONSOLIDATION THERAPY: Patients receive vincristine, mercaptopurine, methotrexate, and leucovorin calcium as in arm I and pegaspargase IM on days 1 and 22.
EXPERIMENTAL INTERIM MAINTENANCE THERAPY: Patients receive vincristine, dexamethasone, mercaptopurine, methotrexate PO, and methotrexate IT as in arm I and pegaspargase IM on days 15 and 36.Standard DI therapy: Patients receive standard DI therapy as in arm I.
GROUP 2 (SR-average ALL): Patients are randomized to 1 of 4 treatment arms.
ARM I: Patients receive standard consolidation therapy, standard interim maintenance therapy, and standard DI therapy as in group 1, arm I.
ARM II:
STANDARD CONSOLIDATION THERAPY: Patients receive standard consolidation therapy as in group 1, arm I. Augmented interim maintenance therapy: Patients receive vincristine IV and methotrexate IV on days 1, 11, 21, 31, and 41; pegaspargase IM on days 2 and 22; and methotrexate IT on days 1 and 31. Patients with DS receive leucovorin calcium PO at 48 and 60 hours after each dose of methotrexate IT. Augmented DI therapy: Patients receive vincristine IV on days 1, 8, 15, 43, and 50; dexamethasone IV or PO BID on days 1-21; doxorubicin hydrochloride IV over 15 minutes to 2 hours on days 1, 8, and 15; pegaspargase IM on day 4, 5, or 6 AND day 43; cyclophosphamide IV over 30 minutes on day 29; cytarabine IV or SC on days 29-32 and 36-39; thioguanine PO on days 29-42; and methotrexate IT on days 1, 29, and 36. Patients with DS receive dexamethasone on days 1-7 and 15-21 and leucovorin calcium PO at 48 and 60 hours after each dose of methotrexate IT.
ARM III:
INTENSIFIED CONSOLIDATION THERAPY: Patients receive cyclophosphamide IV over 30 minutes on days 1 and 29; cytarabine IV or SC on days 1-4, 8-11, 29-32, and 36-39; mercaptopurine PO on days 1-14 and 29-42; vincristine IV on days 15, 22, 43, and 50; pegaspargase IM on days 15 and 43; and methotrexate IT on days 1, 8, 15*, and 22*. Patients with DS receive leucovorin calcium PO at 48 and 60 hours after each dose of methotrexate IT*.
NOTE: *Patients with CNS3 disease at diagnosis do not receive methotrexate on days 15 and 22 or leucovorin calcium.
STANDARD INTERIM MAINTENANCE THERAPY: Patients receive standard interim maintenance therapy as in group 1, arm I.
STANDARD DI THERAPY: Patients receive standard DI therapy as in group 1, arm I.
ARM IV:
INTENSIFIED CONSOLIDATION THERAPY: Patients receive intensified consolidation therapy as in group 2, arm III.
AUGMENTED INTERIM MAINTENANCE THERAPY: Patients receive augmented interim maintenance therapy as in group 2, arm II.
AUGMENTED DI THERAPY: Patients receive augmented DI therapy as in group 2, arm II.
GROUP 3 (SR-high ALL): Patients receive the following therapy: Intensified consolidation therapy: Patients receive intensified consolidation therapy as in group 2, arm III.
AUGMENTED INTERIM MAINTENANCE* THERAPY: Patients receive augmented interim maintenance therapy as in group 2, arm II. Treatment repeats every 56 days for 2 courses.
NOTE: *As of Amendment #7, all SR-High patients currently receiving AIM 1 therapy should complete this phase of therapy and proceed to ADI 1 therapy as originally planned including Capizzi methotrexate during AIM 1. Upon completion of ADI 1, patients should receive a second Interim Maintenance phase with high-dose methotrexate (IM HD) rather than Capizzi methotrexate. Patients should then proceed to ADI 2 and then Maintenance.
AUGMENTED DI* THERAPY: Patients receive augmented DI therapy as in group 2, arm II. Treatment repeats every 56 days for 2 courses**.
NOTE: *As of Amendment #7, all SR-High patients currently receiving ADI 1 therapy should complete this phase of therapy as originally planned. Upon completion of ADI 1, patients should receive a second Interim Maintenance phase with IM HD. Patients should then proceed to ADI 2 and then Maintenance.
NOTE: **Patients with CNS3 disease at diagnosis also undergo cranial radiotherapy on days 29-33 and 36-40 during course 2 only; these patients do not receive methotrexate on day 36, thioguanine, or leucovorin calcium.
MAINTENANCE THERAPY: All patients receive vincristine IV on days 1, 29, and 57; oral dexamethasone twice daily on days 1-5, 29-33, and 57-61; oral methotrexate on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; oral mercaptopurine on days 1-84; and methotrexate IT* on day 1. Courses repeat every 84 days for a total of 2 years from the start of interim maintenance therapy for female patients and 3 years from the start of interim maintenance therapy for male patients.
NOTE: *SR-High or CNS3 patients should receive up to a maximum of 23 intrathecal treatments for females and 26 intrathecal treatments for males.
After the completion of study treatment, patients are followed every 1-2 months for 2 years, every 3 months for 1 year, and then every 6-12 months for 2 years.
Conditions Module
Conditions
Acute Lymphoblastic Leukemia
Childhood B Acute Lymphoblastic Leukemia
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
5,377Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Group 0 Induction Therapy
Experimental
All patients receive cytarabine intrathecally (IT) on day 1; vincristine IV on days 1, 8, 15, and 22; dexamethasone IV or orally (PO) twice daily (BID) on days 1-28; pegaspargase intramuscularly (IM) (may give IV over 1 to 2 hours) on day 4, 5, or 6; and methotrexate IT on days 8 and 29 (and days 15 and 22 for patients with CNS3 disease). Patients with Down syndrome (DS) receive leucovorin calcium PO at 48 and 60 hours after each dose of methotrexate IT. Patients are assessed for response on day 29. Patients with M1 bone marrow AND minimal residual disease (MRD) < 0.1% OR MRD >= 0.1% and < 1% proceed to therapy in part II. Patients with M2 bone marrow OR M1 bone marrow AND MRD >= 1% proceed to extended induction therapy. Patients with M3 bone marrow are removed from the study.
Drug: Cytarabine
Drug: Dexamethasone
Drug: Leucovorin Calcium
Drug: Methotrexate
Drug: Pegaspargase
Drug: Vincristine Sulfate
Group 1-SR-low ALL, Arm I (combination chemotherapy)
Active Comparator
Patients receive standard consolidation therapy, standard interim maintenance therapy, and standard delayed intensification (DI) therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years
Drug: Cyclophosphamide
Drug: Cytarabine
Drug: Dexamethasone
Drug: Doxorubicin Hydrochloride
Drug: Leucovorin Calcium
Drug: Mercaptopurine
Drug: Methotrexate
Drug: Pegaspargase
Drug: Thioguanine
Drug: Vincristine Sulfate
Group 1-SR-low ALL, arm II (combination chemotherapy)
Experimental
Patients receive experimental consolidation therapy, experimental interim maintenance therapy, and standard DI therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
3-Dimensional Conformal Radiation Therapy
Radiation
Some patients undergo cranial radiotherapy
Group 1-SR-low ALL, arm II (combination chemotherapy)
Group 2-SR-avg ALL, arm I (combination chemotherapy)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Event-free Survival (EFS) for SR-Average ALL Patients
EFS for SR-Average with standard and Intensified Consolidation. Event Free Probability where EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free.
6 years
Event-free Survival (EFS) for SR-Low Patients
Event Free Probability where EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free.
6 years
Secondary Outcomes
Measure
Description
Time Frame
Health-related Quality of Life Relative to Physical, Social and Emotional Impairment
To identify potentially modifiable factors associated with impaired health related quality of life (HRQOL) at different periods of therapy in the patients who are SR-average enrolled on the standard risk ALL study.Standardized scores will be computed for child function using the gender and age-adjusted scores available from normative data from a healthy population of about 10,000 children. The various domains of family functioning will be assessed using well-validated instruments and analyzed as a dichotomous variable (impaired vs. non-impaired family functioning). Multiple regression analysis will be used to test the effect of family functioning (adjusted for therapy given, age at diagnosis, gender, socioeconomic status and other factors) on child function.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Patients must be enrolled on AALL03B1 prior to enrollment on AALL0331
Standard-risk (SR) disease meeting 1 of the following criteria:
SR-average by age and WBC
No unfavorable features
Rapid early responder (RER) by day 15
CNS 1 or 2
Minimal residual disease (MRD) negative on day 29
Trisomies of 4, 10, and 17 or TEL-AML1 translocation and RER and CNS2 allowed
SR-low by age and WBC
No unfavorable features
RER by day 15
MRD negative on day 29
CNS1
Favorable cytogenetics-trisomies of 4, 10, and 17 or TEL-AML translocation
SR-high
Unfavorable features meeting ≥ 1 of the following criteria:
MLL rearrangements and RER
Steroid pretreatment
CNS3
Slow early responder by morphology or MRD
Patients with Down syndrome are allowed
Patients with overt testicular disease are not eligible for this study, but may be eligible for AALL0232
Patients shall have had no prior cytotoxic chemotherapy with the exception of steroids and intrathecal cytarabine; intrathecal chemotherapy with cytarabine is allowed prior to registration for patient convenience; this is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture; (Note: the central nervous system [CNS] status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment
Patients receiving prior steroid therapy may be eligible for AALL0331 study
Patients with a contraindication to additional asparaginase therapy, following Induction, are not eligible for the Standard Risk-Low study, and should be removed from protocol therapy at the end of Induction
Patients who are assigned to the standard risk-average group following Induction and who meet the HRQOL
Age at diagnosis >= 2 years (note that this is a more restrictive age range than for the therapeutic component of the study)
At least one parent with reading comprehension of English or Spanish languages for which validated surveys exist
Diagnosis at one of the institutions participating in this limited institution correlative study
A parent or legal guardian must sign a written informed consent/parental permission for all patients
All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
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.
All patients receive cytarabine intrathecally (IT) on day 1; vincristine IV on days 1, 8, 15, and 22; dexamethasone IV or orally (PO) twice daily (BID) on days 1-28; pegaspargase intramuscularly (IM) (may give IV over 1 to 2 hours) on day 4, 5, or 6; and methotrexate IT on days 8 and 29 (and days 15 and 22 for patients with CNS3 disease). Patients with Down syndrome (DS) receive leucovorin calcium PO at 48 and 60 hours after each dose of methotrexate IT. Patients are assessed for response on day 29. Patients with M1 bone marrow AND minimal residual disease (MRD) < 0.1% OR MRD >= 0.1% and < 1% proceed to therapy in part II. Patients with M2 bone marrow OR M1 bone marrow AND MRD >= 1% proceed to extended induction therapy. Patients with M3 bone marrow are removed from the study.
Group 2-SR-avg ALL, arm I (combination chemotherapy)
Active Comparator
Patients receive standard consolidation therapy, standard interim maintenance therapy, and standard DI therapy as in group 1, arm I, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
Group 2-SR-avg ALL, arm II (combination chemotherapy)
Experimental
Patients receive standard consolidation therapy, augmented interim maintenance therapy, augmented DI therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
Group 2-SR-avg ALL, arm III (combination chemotherapy)
Active Comparator
Patients receive intensified consolidation therapy, standard interim maintenance therapy, and standard DI therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
Group 2-SR-avg ALL, arm IV (combination chemotherapy)
Active Comparator
Patients receive intensified consolidation therapy, augmented interim maintenance therapy, and augmented DI therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
Patients receive intensified consolidation therapy, augmented interim maintenance therapy (2 courses), and augmented DI therapy (2 courses), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
Group 1-SR-low ALL, Arm I (combination chemotherapy)
Group 1-SR-low ALL, arm II (combination chemotherapy)
Group 2-SR-avg ALL, arm I (combination chemotherapy)
Group 2-SR-avg ALL, arm II (combination chemotherapy)
Group 2-SR-avg ALL, arm III (combination chemotherapy)
Group 2-SR-avg ALL, arm IV (combination chemotherapy)
Group 3-SR-high ALL, combination chemotherapy
Adinepar
Calcifolin
Calcium (6S)-Folinate
Calcium Folinate
Calcium Leucovorin
Calfolex
Calinat
Cehafolin
Citofolin
Citrec
Citrovorum Factor
Cromatonbic Folinico
Dalisol
Disintox
Divical
Ecofol
Emovis
Factor, Citrovorum
Flynoken A
Folaren
Folaxin
FOLI-cell
Foliben
Folidan
Folidar
Folinac
Folinate Calcium
folinic acid
Folinic Acid Calcium Salt Pentahydrate
Folinoral
Folinvit
Foliplus
Folix
Imo
Lederfolat
Lederfolin
Leucosar
leucovorin
Rescufolin
Rescuvolin
Tonofolin
Wellcovorin
Mercaptopurine
Drug
Given PO
Group 1-SR-low ALL, Arm I (combination chemotherapy)
Group 1-SR-low ALL, arm II (combination chemotherapy)
Group 2-SR-avg ALL, arm I (combination chemotherapy)
Group 2-SR-avg ALL, arm III (combination chemotherapy)
Group 2-SR-avg ALL, arm IV (combination chemotherapy)
Group 3-SR-high ALL, combination chemotherapy
3H-Purine-6-thiol
6 MP
6 Thiohypoxanthine
6 Thiopurine
6-Mercaptopurine
6-Mercaptopurine Monohydrate
6-MP
6-Purinethiol
6-Thiopurine
6-Thioxopurine
6H-Purine-6-thione, 1,7-dihydro- (9CI)
7-Mercapto-1,3,4,6-tetrazaindene
Alti-Mercaptopurine
Azathiopurine
Bw 57-323H
Flocofil
Ismipur
Leukerin
Leupurin
Mercaleukim
Mercaleukin
Mercaptina
Mercaptopurinum
Mercapurin
Mern
NCI-C04886
Puri-Nethol
Purimethol
Purine, 6-mercapto-
Purine-6-thiol (8CI)
Purine-6-thiol, monohydrate
Purinethiol
Purinethol
U-4748
WR-2785
Methotrexate
Drug
Given IM or IT
Group 0 Induction Therapy
Group 1-SR-low ALL, Arm I (combination chemotherapy)
Group 1-SR-low ALL, arm II (combination chemotherapy)
Group 2-SR-avg ALL, arm I (combination chemotherapy)
Group 2-SR-avg ALL, arm II (combination chemotherapy)
Group 2-SR-avg ALL, arm III (combination chemotherapy)
Group 2-SR-avg ALL, arm IV (combination chemotherapy)
Group 3-SR-high ALL, combination chemotherapy
Abitrexate
Alpha-Methopterin
Amethopterin
Brimexate
CL 14377
CL-14377
Emtexate
Emthexat
Emthexate
Farmitrexat
Fauldexato
Folex
Folex PFS
Lantarel
Ledertrexate
Lumexon
Maxtrex
Medsatrexate
Metex
Methoblastin
Methotrexate LPF
Methotrexate Methylaminopterin
Methotrexatum
Metotrexato
Metrotex
Mexate
Mexate-AQ
MTX
Novatrex
Rheumatrex
Texate
Tremetex
Trexeron
Trixilem
WR-19039
Pegaspargase
Drug
Given IM
Group 0 Induction Therapy
Group 1-SR-low ALL, Arm I (combination chemotherapy)
Group 1-SR-low ALL, arm II (combination chemotherapy)
Group 2-SR-avg ALL, arm I (combination chemotherapy)
Group 2-SR-avg ALL, arm II (combination chemotherapy)
Group 2-SR-avg ALL, arm III (combination chemotherapy)
Group 2-SR-avg ALL, arm IV (combination chemotherapy)
Group 3-SR-high ALL, combination chemotherapy
L-Asparaginase with Polyethylene Glycol
Oncaspar
Oncaspar-IV
PEG-Asparaginase
PEG-L-Asparaginase
PEG-L-Asparaginase (Enzon - Kyowa Hakko)
PEGLA
Polyethylene Glycol L-Asparaginase
Polyethylene Glycol-L-Asparaginase
Thioguanine
Drug
Given PO
Group 1-SR-low ALL, Arm I (combination chemotherapy)
Group 2-SR-avg ALL, arm I (combination chemotherapy)
Group 2-SR-avg ALL, arm II (combination chemotherapy)
Group 2-SR-avg ALL, arm III (combination chemotherapy)
Group 2-SR-avg ALL, arm IV (combination chemotherapy)
Group 3-SR-high ALL, combination chemotherapy
2-Amino 6MP
2-Amino-1,7-dihydro-6H-purine-6-thione
2-Amino-6-mercaptopurine
2-Amino-6-purinethiol
2-Aminopurin-6-thiol
2-Aminopurine-6(1H)-thione
2-Aminopurine-6-thiol
2-Aminopurine-6-thiol Hemihydrate
2-Mercapto-6-aminopurine
6-Amino-2-mercaptopurine
6-Mercapto-2-aminopurine
6-Mercaptoguanine
6-TG
6H-Purine-6-thione, 2-amino-1,7-dihydro- (9CI)
BW 5071
Lanvis
Tabloid
Thioguanine Hemihydrate
Thioguanine Hydrate
Tioguanin
Tioguanine
Wellcome U3B
WR-1141
X 27
Vincristine Sulfate
Drug
Given IV
Group 0 Induction Therapy
Group 1-SR-low ALL, Arm I (combination chemotherapy)
Group 1-SR-low ALL, arm II (combination chemotherapy)
Group 2-SR-avg ALL, arm II (combination chemotherapy)
Group 2-SR-avg ALL, arm III (combination chemotherapy)
Group 2-SR-avg ALL, arm IV (combination chemotherapy)
Group 3-SR-high ALL, combination chemotherapy
Kyocristine
Leurocristine Sulfate
Leurocristine, sulfate
Oncovin
Vincasar
Vincosid
Vincrex
Vincristine, sulfate
At 1, 6 and 12 months after diagnosis and, 3 months post-therapy
Event-Free Survival Probability According to MRD Status End Induction (Day 29)
Event-Free survival by Day 29 MRD status (negative vs positive), Event Free Probability (time from study entry to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free.
MRD at Day 29 of therapy
Overall Survival Probability (OS) According to Induction Day 29 MRD Status
Overall survival by Day 29 MRD status (negative vs positive), Overall survival defined as time from study entry to death or date of last contact for patients who are alive.
Overall Survival Probability of 6 years
Early Marrow Status (EMS) by MRD Status End Induction (Day 29)
Early Marrow Status defined as M1 versus M2/M3 marrow is correlated with MRD (Positive vs. Negative)
Early Marrow Status at Day 15, MRD Status at Day 29 of therapy.
Optimal Time Point for Advance Health Related Quality of Life Intervention
Percentage of patients with elevated Anxiety.
At 1 month after diagnosis and 3 months post-therapy.
Event-free Survival (EFS) for SR-High Patients.
Event Free Probability where EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free.
6 years
Event-Free Survival (EFS) for Low MRD (Negative) Subjects by Genetic Subset (TEL/Trisomy Positive vs Negative)
Event-free probability where EFS is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free.
6 years
Birmingham
Alabama
35233
United States
USA Health Strada Patient Care Center
Mobile
Alabama
36604
United States
Banner Children's at Desert
Mesa
Arizona
85202
United States
Phoenix Childrens Hospital
Phoenix
Arizona
85016
United States
Banner University Medical Center - Tucson
Tucson
Arizona
85719
United States
Arkansas Children's Hospital
Little Rock
Arkansas
72202-3591
United States
University of Arkansas for Medical Sciences
Little Rock
Arkansas
72205
United States
Kaiser Permanente Downey Medical Center
Downey
California
90242
United States
City of Hope Comprehensive Cancer Center
Duarte
California
91010
United States
Loma Linda University Medical Center
Loma Linda
California
92354
United States
Miller Children's and Women's Hospital Long Beach
Long Beach
California
90806
United States
Children's Hospital Los Angeles
Los Angeles
California
90027
United States
Cedars Sinai Medical Center
Los Angeles
California
90048
United States
Mattel Children's Hospital UCLA
Los Angeles
California
90095
United States
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles
California
90095
United States
Valley Children's Hospital
Madera
California
93636
United States
UCSF Benioff Children's Hospital Oakland
Oakland
California
94609
United States
Kaiser Permanente-Oakland
Oakland
California
94611
United States
Children's Hospital of Orange County
Orange
California
92868
United States
Lucile Packard Children's Hospital Stanford University
Palo Alto
California
94304
United States
Sutter Medical Center Sacramento
Sacramento
California
95816
United States
University of California Davis Comprehensive Cancer Center
Sacramento
California
95817
United States
Rady Children's Hospital - San Diego
San Diego
California
92123
United States
UCSF Medical Center-Mount Zion
San Francisco
California
94115
United States
UCSF Medical Center-Parnassus
San Francisco
California
94143
United States
Santa Barbara Cottage Hospital
Santa Barbara
California
93102
United States
Harbor-University of California at Los Angeles Medical Center
Torrance
California
90502
United States
Children's Hospital Colorado
Aurora
Colorado
80045
United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver
Colorado
80218
United States
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Denver
Colorado
80218
United States
University of Connecticut
Farmington
Connecticut
06030
United States
Connecticut Children's Medical Center
Hartford
Connecticut
06106
United States
Yale University
New Haven
Connecticut
06520
United States
Alfred I duPont Hospital for Children
Wilmington
Delaware
19803
United States
MedStar Georgetown University Hospital
Washington D.C.
District of Columbia
20007
United States
Children's National Medical Center
Washington D.C.
District of Columbia
20010
United States
Broward Health Medical Center
Fort Lauderdale
Florida
33316
United States
Lee Memorial Health System
Fort Myers
Florida
33901
United States
Golisano Children's Hospital of Southwest Florida
Fort Myers
Florida
33908
United States
University of Florida Health Science Center - Gainesville
Gainesville
Florida
32610
United States
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood
Florida
33021
United States
Nemours Children's Clinic-Jacksonville
Jacksonville
Florida
32207
United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami
Florida
33136
United States
Nicklaus Children's Hospital
Miami
Florida
33155
United States
Miami Cancer Institute
Miami
Florida
33176
United States
AdventHealth Orlando
Orlando
Florida
32803
United States
Nemours Children's Clinic - Orlando
Orlando
Florida
32806
United States
Orlando Health Cancer Institute
Orlando
Florida
32806
United States
Nemours Children's Hospital
Orlando
Florida
32827
United States
Nemours Children's Clinic - Pensacola
Pensacola
Florida
32504
United States
Sacred Heart Hospital
Pensacola
Florida
32504
United States
Johns Hopkins All Children's Hospital
St. Petersburg
Florida
33701
United States
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa
Florida
33607
United States
Saint Mary's Hospital
West Palm Beach
Florida
33407
United States
Children's Healthcare of Atlanta - Egleston
Atlanta
Georgia
30322
United States
Emory University Hospital/Winship Cancer Institute
Atlanta
Georgia
30322
United States
Augusta University Medical Center
Augusta
Georgia
30912
United States
Memorial Health University Medical Center
Savannah
Georgia
31404
United States
University of Hawaii Cancer Center
Honolulu
Hawaii
96813
United States
Tripler Army Medical Center
Honolulu
Hawaii
96859
United States
Saint Luke's Cancer Institute - Boise
Boise
Idaho
83712
United States
Lurie Children's Hospital-Chicago
Chicago
Illinois
60611
United States
University of Illinois
Chicago
Illinois
60612
United States
University of Chicago Comprehensive Cancer Center
Chicago
Illinois
60637
United States
Loyola University Medical Center
Maywood
Illinois
60153
United States
Advocate Children's Hospital-Oak Lawn
Oak Lawn
Illinois
60453
United States
Advocate Lutheran General Hospital
Park Ridge
Illinois
60068
United States
Saint Jude Midwest Affiliate
Peoria
Illinois
61637
United States
Southern Illinois University School of Medicine
Springfield
Illinois
62702
United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis
Indiana
46202
United States
Riley Hospital for Children
Indianapolis
Indiana
46202
United States
Saint Vincent Hospital and Health Care Center
Indianapolis
Indiana
46260
United States
Blank Children's Hospital
Des Moines
Iowa
50309
United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City
Iowa
52242
United States
University of Kansas Cancer Center
Kansas City
Kansas
66160
United States
University of Kentucky/Markey Cancer Center
Lexington
Kentucky
40536
United States
Norton Children's Hospital
Louisville
Kentucky
40202
United States
Tulane University Health Sciences Center
New Orleans
Louisiana
70112
United States
Children's Hospital New Orleans
New Orleans
Louisiana
70118
United States
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
Ascension Saint John Hospital
Detroit
Michigan
48236
United States
Michigan State University Clinical Center
East Lansing
Michigan
48824-7016
United States
Hurley Medical Center
Flint
Michigan
48503
United States
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids
Michigan
49503
United States
Spectrum Health at Butterworth Campus
Grand Rapids
Michigan
49503
United States
Bronson Methodist Hospital
Kalamazoo
Michigan
49007
United States
Kalamazoo Center for Medical Studies
Kalamazoo
Michigan
49008
United States
Beaumont Children's Hospital-Royal Oak
Royal Oak
Michigan
48073
United States
William Beaumont Hospital-Royal Oak
Royal Oak
Michigan
48073
United States
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis
Minnesota
55404
United States
University of Minnesota/Masonic Cancer Center
Minneapolis
Minnesota
55455
United States
Mayo Clinic in Rochester
Rochester
Minnesota
55905
United States
University of Mississippi Medical Center
Jackson
Mississippi
39216
United States
Columbia Regional
Columbia
Missouri
65201
United States
University of Missouri - Ellis Fischel
Columbia
Missouri
65212
United States
Children's Mercy Hospitals and Clinics
Kansas City
Missouri
64108
United States
Cardinal Glennon Children's Medical Center
St Louis
Missouri
63104
United States
Washington University School of Medicine
St Louis
Missouri
63110
United States
Children's Hospital and Medical Center of Omaha
Omaha
Nebraska
68114
United States
University of Nebraska Medical Center
Omaha
Nebraska
68198
United States
Nevada Cancer Research Foundation NCORP
Las Vegas
Nevada
89169
United States
Dartmouth Hitchcock Medical Center
Lebanon
New Hampshire
03756
United States
Hackensack University Medical Center
Hackensack
New Jersey
07601
United States
Saint Barnabas Medical Center
Livingston
New Jersey
07039
United States
Morristown Medical Center
Morristown
New Jersey
07960
United States
Saint Peter's University Hospital
New Brunswick
New Jersey
08901
United States
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick
New Jersey
08903
United States
Newark Beth Israel Medical Center
Newark
New Jersey
07112
United States
Saint Joseph's Regional Medical Center
Paterson
New Jersey
07503
United States
Overlook Hospital
Summit
New Jersey
07902
United States
University of New Mexico Cancer Center
Albuquerque
New Mexico
87102
United States
Albany Medical Center
Albany
New York
12208
United States
Brooklyn Hospital Center
Brooklyn
New York
11201
United States
Brookdale Hospital Medical Center
Brooklyn
New York
11212
United States
Maimonides Medical Center
Brooklyn
New York
11219
United States
Roswell Park Cancer Institute
Buffalo
New York
14263
United States
NYU Winthrop Hospital
Mineola
New York
11501
United States
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park
New York
11040
United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York
New York
10016
United States
Mount Sinai Hospital
New York
New York
10029
United States
Memorial Sloan Kettering Cancer Center
New York
New York
10065
United States
NYP/Weill Cornell Medical Center
New York
New York
10065
United States
Stony Brook University Medical Center
Stony Brook
New York
11794
United States
State University of New York Upstate Medical University
Escherich CS, Chen W, Li Y, Yang W, Nishii R, Li Z, Raetz EA, Devidas M, Wu G, Nichols KE, Inaba H, Pui CH, Jeha S, Camitta BM, Larsen E, Hunger SP, Loh ML, Yang JJ. Germ line genetic NBN variation and predisposition to B-cell acute lymphoblastic leukemia in children. Blood. 2024 May 30;143(22):2270-2283. doi: 10.1182/blood.2023023336.
Karol SE, Mattano LA Jr, Yang W, Maloney KW, Smith C, Liu C, Ramsey LB, Fernandez CA, Chang TY, Neale G, Cheng C, Mardis E, Fulton R, Scheet P, San Lucas FA, Larsen EC, Loh ML, Raetz EA, Hunger SP, Devidas M, Relling MV. Genetic risk factors for the development of osteonecrosis in children under age 10 treated for acute lymphoblastic leukemia. Blood. 2016 Feb 4;127(5):558-64. doi: 10.1182/blood-2015-10-673848. Epub 2015 Nov 20.
Teachey DT, Rheingold SR, Maude SL, Zugmaier G, Barrett DM, Seif AE, Nichols KE, Suppa EK, Kalos M, Berg RA, Fitzgerald JC, Aplenc R, Gore L, Grupp SA. Cytokine release syndrome after blinatumomab treatment related to abnormal macrophage activation and ameliorated with cytokine-directed therapy. Blood. 2013 Jun 27;121(26):5154-7. doi: 10.1182/blood-2013-02-485623. Epub 2013 May 15.
FG001
Group 1-SR-low ALL, Arm I-combination Chemotherapy
Patients receive standard consolidation therapy (vincristine sulfate, mercaptopurine and methotrexate. Patients with Down syndrome (DS) receive leucovorin calcium), standard interim maintenance therapy (vincristine sulfate, dexamethasone, mercaptopurine and methotrexate. Patients with DS receive leucovorin calcium), and standard delayed intensification (DI) therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine and methotrexate. Patients with DS receive dexamethasone, leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
doxorubicin hydrochloride: Given IV or IT
cytarabine: Given IV or SC
dexamethasone: Given IV or PO
pegaspargase: Given IM
methotrexate: Given IM or IT
leucovorin calcium: Given PO
mercaptopurine: Given PO
cyclophosphamide: Given IV
thioguanine: Given PO
vincristine sulfate: Given IV
FG002
Group 1-SR-low ALL, Arm II-combination Chemotherapy
Patients receive experimental consolidation therapy (vincristine sulfate, mercaptopurine, MTX, leucovorin calcium and pegaspargase), experimental interim maintenance therapy (vincristine sulfate, dexamethasone, mercaptopurine, MTX and pegaspargase), and standard DI therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine and MTX), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
doxorubicin hydrochloride: Given IV or IT
cytarabine: Given IV or SC
dexamethasone: Given IV or PO
pegaspargase: Given IM
methotrexate: Given IM or IT
leucovorin calcium: Given PO
mercaptopurine: Given PO
cyclophosphamide: Given IV
thioguanine: Given PO
vincristine sulfate: Given IV
FG003
Group 2-SR-avg ALL, Arm I-combination Chemotherapy
Patients receive standard consolidation therapy (vincristine sulfate, mercaptopurine and methotrexate. Patients with Down syndrome (DS) receive leucovorin calcium), standard interim maintenance therapy (vincristine sulfate, dexamethasone, mercaptopurine and methotrexate. Patients with DS receive leucovorin calcium), and standard delayed intensification (DI) therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine and methotrexate. Patients with DS receive dexamethasone, leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
doxorubicin hydrochloride: Given IV or IT
cytarabine: Given IV or SC
dexamethasone: Given IV or PO
pegaspargase: Given IM
methotrexate: Given IM or IT
leucovorin calcium: Given PO
mercaptopurine: Given PO
cyclophosphamide: Given IV
thioguanine: Given PO
vincristine sulfate: Given IV
FG004
Group 2-SR-avg ALL, Arm II-combination Chemotherapy
Patients receive standard consolidation therapy (vincristine sulfate, mercaptopurine and MTX. Patients with Down syndrome (DS) receive leucovorin calcium), augmented interim maintenance therapy (vincristine sulfate, MTX and pegaspargase. Patients with DS receive leucovorin calcium), augmented DI therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine, MTX. Patients with DS receive dexamethasone and leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
doxorubicin hydrochloride: Given IV or IT
cytarabine: Given IV or SC
dexamethasone: Given IV or PO
pegaspargase: Given IM
methotrexate: Given IM or IT
leucovorin calcium: Given PO
mercaptopurine: Given PO
cyclophosphamide: Given IV
thioguanine: Given PO
vincristine sulfate: Given IV
FG005
Group 2-SR-avg ALL, Arm III-combination Chemotherapy
Patients receive intensified consolidation therapy (cyclophosphamide, cytarabine, mercaptopurine and vincristine sulfate, pegaspargase, MTX. Patients with DS receive oral leucovorin calcium), standard interim maintenance therapy (vincristine sulfate, dexamethasone, mercaptopurine and MTX. Patients with DS receive leucovorin calcium), and standard DI therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine and MTX. Patients with DS receive dexamethasone, leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
doxorubicin hydrochloride: Given IV or IT
cytarabine: Given IV or SC
dexamethasone: Given IV or PO
pegaspargase: Given IM
methotrexate: Given IM or IT
leucovorin calcium: Given PO
mercaptopurine: Given PO
cyclophosphamide: Given IV
thioguanine: Given PO
vincristine sulfate: Given IV
FG006
Group 2-SR-avg ALL, Arm IV-combination Chemotherapy
Patients receive intensified consolidation therapy (cyclophosphamide, cytarabine, mercaptopurine and vincristine sulfate, pegaspargase, MTX. Patients with DS receive oral leucovorin calcium), augmented interim maintenance therapy (vincristine sulfate, MTX and pegaspargase. Patients with DS receive leucovorin calcium), and augmented DI therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine, MTX. Patients with DS receive dexamethasone and leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
doxorubicin hydrochloride: Given IV or IT
cytarabine: Given IV or SC
dexamethasone: Given IV or PO
pegaspargase: Given IM
methotrexate: Given IM or IT
leucovorin calcium: Given PO
mercaptopurine: Given PO
cyclophosphamide: Given IV
thioguanine: Given PO
vincristine sulfate: Given IV
FG007
Group 3-SR-high ALL, Combination Chemotherapy
Patients receive intensified consolidation therapy (cyclophosphamide, cytarabine, mercaptopurine & vincristine sulfate, pegaspargase, methotrexate. Patients with DS receive oral leucovorin calcium), augmented interim maintenance therapy (2 courses - vincristine sulfate, methotrexate and pegaspargase. Patients with DS receive leucovorin calcium), and augmented DI therapy (2 courses - vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine, methotrexate. Patients with DS receive dexamethasone and leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
doxorubicin hydrochloride: Given IV or IT
3-dimensional conformal radiation therapy: Some patients undergo cranial radiotherapy
cytarabine: Given IV or SC
dexamethasone: Given IV or PO
pegaspargase: Given IM
methotrexate: Given IM or IT
leucovorin calcium: Given PO
mercaptopurine
FG0005377 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
COMPLETED
FG0004028 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
NOT COMPLETED
FG0001349 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Type
Comment
Reasons
Adverse Event
FG00014 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Death
FG00024 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG000103 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Ineligible
FG00043 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Refusal
FG000906 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other
FG000258 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Response Assignment
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG001939 subjects
FG002937 subjects
FG003503 subjects
FG004509 subjects
FG005249 subjects
FG006248 subjects
FG007643 subjects
COMPLETED
FG0000 subjects
FG001807 subjects
FG002853 subjects
FG003441 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG001132 subjects
FG00284 subjects
FG00362 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0018 subjects
FG0023 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Group 0 Induction Therapy
All patients receive cytarabine intrathecally (IT) on day 1; vincristine IV on days 1, 8, 15, and 22; dexamethasone IV or orally (PO) twice daily (BID) on days 1-28; pegaspargase intramuscularly (IM) (may give IV over 1 to 2 hours) on day 4, 5, or 6; and methotrexate IT on days 8 and 29 (and days 15 and 22 for patients with CNS3 disease). Patients with Down syndrome (DS) receive leucovorin calcium PO at 48 and 60 hours after each dose of methotrexate IT. Patients are assessed for response on day 29. Patients with M1 bone marrow AND minimal residual disease (MRD) < 0.1% OR MRD >= 0.1% and < 1% proceed to therapy in part II. Patients with M2 bone marrow OR M1 bone marrow AND MRD >= 1% proceed to extended induction therapy. Patients with M3 bone marrow are removed from the study.
cytarabine: Given IV or SC
dexamethasone: Given IV or PO
pegaspargase: Given IM
methotrexate: Given IM or IT
vincristine sulfate: Given IV
Denominators
Units
Counts
Participants
BG0005377
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
BG0005377
Between 18 and 65 years
BG0000
>=65 years
BG000
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG0004.45± 2.10
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002489
Male
BG0002888
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001097
Not Hispanic or Latino
BG0004038
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG00036
Asian
BG000253
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG0005377
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Event-free Survival (EFS) for SR-Average ALL Patients
EFS for SR-Average with standard and Intensified Consolidation. Event Free Probability where EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free.
Only eligible patients are included in this population. Populations are based on enrollments for all four arms initially, and then only for Arms I and II (standard therapy) once Arms III and IV (intensified therapy) were closed to accrual.
Posted
Number
95% Confidence Interval
percent probability
6 years
ID
Title
Description
OG000
Group 2-SR-avg ALL, Arm I-combination Chemotherapy
Patients receive standard consolidation therapy (vincristine sulfate, mercaptopurine and methotrexate. Patients with Down syndrome (DS) receive leucovorin calcium), standard interim maintenance therapy (vincristine sulfate, dexamethasone, mercaptopurine and methotrexate. Patients with DS receive leucovorin calcium), and standard delayed intensification (DI) therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine and methotrexate. Patients with DS receive dexamethasone, leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
doxorubicin hydrochloride: Given IV or IT
cytarabine: Given IV or SC
dexamethasone: Given IV or PO
pegaspargase: Given IM
methotrexate: Given IM or IT
leucovorin calcium: Given PO
mercaptopurine: Given PO
cyclophosphamide: Given IV
thioguanine: Given PO
vincristine sulfate: Given IV
OG001
Group 2-SR-avg ALL, Arm II-combination Chemotherapy
Patients receive standard consolidation therapy (vincristine sulfate, mercaptopurine and MTX. Patients with Down syndrome (DS) receive leucovorin calcium), augmented interim maintenance therapy (vincristine sulfate, MTX and pegaspargase. Patients with DS receive leucovorin calcium), augmented DI therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine, MTX. Patients with DS receive dexamethasone and leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
doxorubicin hydrochloride: Given IV or IT
cytarabine: Given IV or SC
dexamethasone: Given IV or PO
pegaspargase: Given IM
methotrexate: Given IM or IT
leucovorin calcium: Given PO
mercaptopurine: Given PO
cyclophosphamide: Given IV
thioguanine: Given PO
vincristine sulfate: Given IV
OG002
Group 2-SR-avg ALL, Arm III-combination Chemotherapy
Patients receive intensified consolidation therapy (cyclophosphamide, cytarabine, mercaptopurine and vincristine sulfate, pegaspargase, MTX. Patients with DS receive oral leucovorin calcium), standard interim maintenance therapy (vincristine sulfate, dexamethasone, mercaptopurine and MTX. Patients with DS receive leucovorin calcium), and standard DI therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine and MTX. Patients with DS receive dexamethasone, leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
doxorubicin hydrochloride: Given IV or IT
cytarabine: Given IV or SC
dexamethasone: Given IV or PO
pegaspargase: Given IM
methotrexate: Given IM or IT
leucovorin calcium: Given PO
mercaptopurine: Given PO
cyclophosphamide: Given IV
thioguanine: Given PO
vincristine sulfate: Given IV
OG003
Group 2-SR-avg ALL, Arm IV-combination Chemotherapy
Patients receive intensified consolidation therapy (cyclophosphamide, cytarabine, mercaptopurine and vincristine sulfate, pegaspargase, MTX. Patients with DS receive oral leucovorin calcium), augmented interim maintenance therapy (vincristine sulfate, MTX and pegaspargase. Patients with DS receive leucovorin calcium), and augmented DI therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine, MTX. Patients with DS receive dexamethasone and leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
doxorubicin hydrochloride: Given IV or IT
cytarabine: Given IV or SC
dexamethasone: Given IV or PO
pegaspargase: Given IM
methotrexate: Given IM or IT
leucovorin calcium: Given PO
mercaptopurine: Given PO
cyclophosphamide: Given IV
thioguanine: Given PO
vincristine sulfate: Given IV
Units
Counts
Participants
OG000500
OG001509
OG002245
OG003
Title
Denominators
Categories
Standard and Intensified therapy
ParticipantsOG000244
ParticipantsOG001249
ParticipantsOG002245
ParticipantsOG003
Primary
Event-free Survival (EFS) for SR-Low Patients
Event Free Probability where EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free.
Only eligible patients are included in the analysis.
Posted
Number
95% Confidence Interval
Percent probability
6 years
ID
Title
Description
OG000
SR-low ALL, Arm I-combination Chemotherapy
Patients receive standard consolidation therapy (vincristine sulfate, mercaptopurine and methotrexate. Patients with Down syndrome (DS) receive leucovorin calcium), standard interim maintenance therapy (vincristine sulfate, dexamethasone, mercaptopurine and methotrexate. Patients with DS receive leucovorin calcium), and standard delayed intensification (DI) therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine and methotrexate. Patients with DS receive dexamethasone, leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
doxorubicin hydrochloride: Given IV or IT
cytarabine: Given IV or SC
dexamethasone: Given IV or PO
pegaspargase: Given IM
methotrexate: Given IM or IT
leucovorin calcium: Given PO
mercaptopurine: Given PO
cyclophosphamide: Given IV
thioguanine: Given PO
vincristine sulfate: Given IV
OG001
SR-low ALL, Arm II-combination Chemotherapy
Patients receive experimental consolidation therapy (vincristine sulfate, mercaptopurine, MTX, leucovorin calcium and pegaspargase), experimental interim maintenance therapy (vincristine sulfate, dexamethasone, mercaptopurine, MTX and pegaspargase), and standard DI therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine and MTX), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
doxorubicin hydrochloride: Given IV or IT
cytarabine: Given IV or SC
dexamethasone: Given IV or PO
pegaspargase: Given IM
methotrexate: Given IM or IT
leucovorin calcium: Given PO
mercaptopurine: Given PO
cyclophosphamide: Given IV
thioguanine: Given PO
vincristine sulfate: Given IV
Secondary
Health-related Quality of Life Relative to Physical, Social and Emotional Impairment
To identify potentially modifiable factors associated with impaired health related quality of life (HRQOL) at different periods of therapy in the patients who are SR-average enrolled on the standard risk ALL study.Standardized scores will be computed for child function using the gender and age-adjusted scores available from normative data from a healthy population of about 10,000 children. The various domains of family functioning will be assessed using well-validated instruments and analyzed as a dichotomous variable (impaired vs. non-impaired family functioning). Multiple regression analysis will be used to test the effect of family functioning (adjusted for therapy given, age at diagnosis, gender, socioeconomic status and other factors) on child function.
This analysis is restricted to the 160 SR-ALL patients enrolled on Children's Oncology Group (COG) therapeutic trial AALL0331 at 31 sites, who consented to and completed the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales (physical, emotional and social functioning).
Posted
Number
95% Confidence Interval
Percentage of participants
At 1, 6 and 12 months after diagnosis and, 3 months post-therapy
ID
Title
Description
OG000
Induction Therapy
All patients for induction therapy.
Units
Counts
Participants
Secondary
Event-Free Survival Probability According to MRD Status End Induction (Day 29)
Event-Free survival by Day 29 MRD status (negative vs positive), Event Free Probability (time from study entry to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free.
4981 eligible evaluable patients enrolled on AALL0331 had MRD data at Day 29
Posted
Number
95% Confidence Interval
Percent Probability
MRD at Day 29 of therapy
ID
Title
Description
OG000
Induction Therapy, MRD Negative
All patients receive cytarabine intrathecally (IT) on day 1; vincristine IV on days 1, 8, 15, and 22; dexamethasone IV or orally (PO) twice daily (BID) on days 1-28; pegaspargase intramuscularly (IM) (may give IV over 1 to 2 hours) on day 4, 5, or 6; and methotrexate IT on days 8 and 29 (and days 15 and 22 for patients with CNS3 disease). Patients with Down syndrome (DS) receive leucovorin calcium PO at 48 and 60 hours after each dose of methotrexate IT. Patients are assessed for response on day 29. Patients with M1 bone marrow AND minimal residual disease (MRD) < 0.1% OR MRD >= 0.1% and < 1% proceed to therapy in part II. Patients with M2 bone marrow OR M1 bone marrow AND MRD >= 1% proceed to extended induction therapy. Patients with M3 bone marrow are removed from the study.
cytarabine: Given IV or SC
dexamethasone: Given IV or PO
pegaspargase: Given IM
methotrexate: Given IM or IT
vincristine sulfate: Given IV
OG001
Induction Therapy, MRD Positive
Secondary
Overall Survival Probability (OS) According to Induction Day 29 MRD Status
Overall survival by Day 29 MRD status (negative vs positive), Overall survival defined as time from study entry to death or date of last contact for patients who are alive.
4981 eligible evaluable patients enrolled on AALL0331 had MRD data at Day 29.
Posted
Number
95% Confidence Interval
percent probability
Overall Survival Probability of 6 years
ID
Title
Description
OG000
Induction Therapy, MRD Negative
All patients receive cytarabine intrathecally (IT) on day 1; vincristine IV on days 1, 8, 15, and 22; dexamethasone IV or orally (PO) twice daily (BID) on days 1-28; pegaspargase intramuscularly (IM) (may give IV over 1 to 2 hours) on day 4, 5, or 6; and methotrexate IT on days 8 and 29 (and days 15 and 22 for patients with CNS3 disease). Patients with Down syndrome (DS) receive leucovorin calcium PO at 48 and 60 hours after each dose of methotrexate IT. Patients are assessed for response on day 29. Patients with M1 bone marrow AND minimal residual disease (MRD) < 0.1% OR MRD >= 0.1% and < 1% proceed to therapy in part II. Patients with M2 bone marrow OR M1 bone marrow AND MRD >= 1% proceed to extended induction therapy. Patients with M3 bone marrow are removed from the study.
cytarabine: Given IV or SC
dexamethasone: Given IV or PO
pegaspargase: Given IM
methotrexate: Given IM or IT
vincristine sulfate: Given IV
OG001
Induction Therapy, MRD Positive
Secondary
Early Marrow Status (EMS) by MRD Status End Induction (Day 29)
Early Marrow Status defined as M1 versus M2/M3 marrow is correlated with MRD (Positive vs. Negative)
Patients who had MRD day 29 data but their Bone Marrow (BM) days 8/15 data were missing are excluded. This analysis was done with patients who had both MRD and BM data. There were 5 patients excluded in both MRD Negative and MRD Positive groups due to missing days 8/15 BM.
Posted
Count of Participants
Participants
Early Marrow Status at Day 15, MRD Status at Day 29 of therapy.
ID
Title
Description
OG000
All Patients for Induction, MRD Negative
All patients receive cytarabine intrathecally (IT) on day 1; vincristine IV on days 1, 8, 15, and 22; dexamethasone IV or orally (PO) twice daily (BID) on days 1-28; pegaspargase intramuscularly (IM) (may give IV over 1 to 2 hours) on day 4, 5, or 6; and methotrexate IT on days 8 and 29 (and days 15 and 22 for patients with CNS3 disease). Patients with Down syndrome (DS) receive leucovorin calcium PO at 48 and 60 hours after each dose of methotrexate IT. Patients are assessed for response on day 29. Patients with M1 bone marrow AND minimal residual disease (MRD) < 0.1% OR MRD >= 0.1% and < 1% proceed to therapy in part II. Patients with M2 bone marrow OR M1 bone marrow AND MRD >= 1% proceed to extended induction therapy. Patients with M3 bone marrow are removed from the study.
cytarabine: Given IV or SC
dexamethasone: Given IV or PO
pegaspargase: Given IM
methotrexate: Given IM or IT
vincristine sulfate: Given IV
OG001
Secondary
Optimal Time Point for Advance Health Related Quality of Life Intervention
Percentage of patients with elevated Anxiety.
Parents of 159 SR-ALL patients enrolled on Children's Oncology Group (COG) therapeutic trial AALL0331 at 31 sites completed the BASC-2 Anxiety Scale at 1 month after diagnosis, and 3 months post-therapy. Of these, 159 patients had data at 1 month after diagnosis and 96 patients had data at 3 months post therapy.
Posted
Number
95% Confidence Interval
Percentage of participants
At 1 month after diagnosis and 3 months post-therapy.
ID
Title
Description
OG000
Induction Therapy
All patients receive cytarabine intrathecally (IT) on day 1; vincristine IV on days 1, 8, 15, and 22; dexamethasone IV or orally (PO) twice daily (BID) on days 1-28; pegaspargase intramuscularly (IM) (may give IV over 1 to 2 hours) on day 4, 5, or 6; and methotrexate IT on days 8 and 29 (and days 15 and 22 for patients with CNS3 disease). Patients with Down syndrome (DS) receive leucovorin calcium PO at 48 and 60 hours after each dose of methotrexate IT. Patients are assessed for response on day 29. Patients with M1 bone marrow AND minimal residual disease (MRD) < 0.1% OR MRD >= 0.1% and < 1% proceed to therapy in part II. Patients with M2 bone marrow OR M1 bone marrow AND MRD >= 1% proceed to extended induction therapy. Patients with M3 bone marrow are removed from the study.
cytarabine: Given IV or SC
dexamethasone: Given IV or PO
pegaspargase: Given IM
methotrexate: Given IM or IT
vincristine sulfate: Given IV
Secondary
Event-free Survival (EFS) for SR-High Patients.
Event Free Probability where EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free.
CCR: Complete Continuous Remission, where time to event is defined as the time from start of consolidation therapy to first event or date of last follow up for those who did not experience an event. All patients enrolled on the SR-High were used in this analysis regardless of completion of therapy.
Posted
Number
95% Confidence Interval
percent probability
6 years
ID
Title
Description
OG000
Group 3-SR-high ALL, Combination Chemotherapy
Patients receive intensified consolidation therapy (cyclophosphamide, cytarabine, mercaptopurine and vincristine sulfate, pegaspargase, methotrexate. Patients with DS receive oral leucovorin calcium), augmented interim maintenance therapy (2 courses - vincristine sulfate, MTX and pegaspargase. Patients with DS receive leucovorin calcium, and augmented DI therapy (2 courses - vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine,MTX. Patients with DS receive (dexamethasone and leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
doxorubicin hydrochloride: Given IV or IT
3-dimensional conformal radiation therapy: Some patients undergo cranial radiotherapy
cytarabine: Given IV or SC
dexamethasone: Given IV or PO
pegaspargase: Given IM
methotrexate: Given IM or IT
leucovorin calcium: Given PO
mercaptopurine: Given PO
Secondary
Event-Free Survival (EFS) for Low MRD (Negative) Subjects by Genetic Subset (TEL/Trisomy Positive vs Negative)
Event-free probability where EFS is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free.
Patients on the two arms being compared got similar therapy. All patients included in this analysis are MRD negative. SR-Average patients who were CNS2 at diagnosis were excluded in order to have comparable patient cohorts. SR-Low patients are TEL/Trisomy positive while SR-Average patients are TEL/Trisomy negative.
Posted
Number
95% Confidence Interval
Percent probability
6 years
ID
Title
Description
OG000
Group 1-SR-low ALL, Arm I-combination Chemotherapy
Patients receive standard consolidation therapy (vincristine sulfate, mercaptopurine and methotrexate. Patients with Down syndrome (DS) receive leucovorin calcium), standard interim maintenance therapy (vincristine sulfate, dexamethasone, mercaptopurine and methotrexate. Patients with DS receive leucovorin calcium), and standard delayed intensification (DI) therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine and methotrexate. Patients with DS receive dexamethasone, leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
doxorubicin hydrochloride: Given IV or IT
cytarabine: Given IV or SC
dexamethasone: Given IV or PO
pegaspargase: Given IM
methotrexate: Given IM or IT
leucovorin calcium: Given PO
mercaptopurine: Given PO
cyclophosphamide: Given IV
thioguanine: Given PO
vincristine sulfate: Given IV
Time Frame
Not provided
Description
Only eligible patients are included in the toxicity analysis.
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
Group 0 Induction Therapy
All patients receive cytarabine intrathecally (IT) on day 1; vincristine IV on days 1, 8, 15, and 22; dexamethasone IV or orally (PO) twice daily (BID) on days 1-28; pegaspargase intramuscularly (IM) (may give IV over 1 to 2 hours) on day 4, 5, or 6; and methotrexate IT on days 8 and 29 (and days 15 and 22 for patients with CNS3 disease). Patients with Down syndrome (DS) receive leucovorin calcium PO at 48 and 60 hours after each dose of methotrexate IT. Patients are assessed for response on day 29. Patients with M1 bone marrow AND minimal residual disease (MRD) < 0.1% OR MRD >= 0.1% and < 1% proceed to therapy in part II. Patients with M2 bone marrow OR M1 bone marrow AND MRD >= 1% proceed to extended induction therapy. Patients with M3 bone marrow are removed from the study.
cytarabine: Given IV or SC
dexamethasone: Given IV or PO
pegaspargase: Given IM
methotrexate: Given IM or IT
vincristine sulfate: Given IV
29
1,306
790
1,306
EG001
Group 1-SR-low ALL, Arm I-combination Chemotherapy
Patients receive standard consolidation therapy (vincristine sulfate, mercaptopurine and methotrexate. Patients with Down syndrome (DS) receive leucovorin calcium), standard interim maintenance therapy (vincristine sulfate, dexamethasone, mercaptopurine and methotrexate. Patients with DS receive leucovorin calcium), and standard delayed intensification (DI) therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine and methotrexate. Patients with DS receive dexamethasone, leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
doxorubicin hydrochloride: Given IV or IT
cytarabine: Given IV or SC
dexamethasone: Given IV or PO
pegaspargase: Given IM
methotrexate: Given IM or IT
leucovorin calcium: Given PO
mercaptopurine: Given PO
cyclophosphamide: Given IV
thioguanine: Given PO
vincristine sulfate: Given IV
14
931
901
931
EG002
Group 1-SR-low ALL, Arm II-combination Chemotherapy
Patients receive experimental consolidation therapy (vincristine sulfate, mercaptopurine, MTX, leucovorin calcium and pegaspargase), experimental interim maintenance therapy (vincristine sulfate, dexamethasone, mercaptopurine, MTX and pegaspargase), and standard DI therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine and MTX), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
doxorubicin hydrochloride: Given IV or IT
cytarabine: Given IV or SC
dexamethasone: Given IV or PO
pegaspargase: Given IM
methotrexate: Given IM or IT
leucovorin calcium: Given PO
mercaptopurine: Given PO
cyclophosphamide: Given IV
thioguanine: Given PO
vincristine sulfate: Given IV
7
931
909
931
EG003
Group 2-SR-avg ALL, Arm I-combination Chemotherapy
Patients receive standard consolidation therapy (vincristine sulfate, mercaptopurine and methotrexate. Patients with Down syndrome (DS) receive leucovorin calcium), standard interim maintenance therapy (vincristine sulfate, dexamethasone, mercaptopurine and methotrexate. Patients with DS receive leucovorin calcium), and standard delayed intensification (DI) therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine and methotrexate. Patients with DS receive dexamethasone, leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
doxorubicin hydrochloride: Given IV or IT
cytarabine: Given IV or SC
dexamethasone: Given IV or PO
pegaspargase: Given IM
methotrexate: Given IM or IT
leucovorin calcium: Given PO
mercaptopurine: Given PO
cyclophosphamide: Given IV
thioguanine: Given PO
vincristine sulfate: Given IV
4
501
487
501
EG004
Group 2-SR-avg ALL, Arm II-combination Chemotherapy
Patients receive standard consolidation therapy (vincristine sulfate, mercaptopurine and MTX. Patients with Down syndrome (DS) receive leucovorin calcium), augmented interim maintenance therapy (vincristine sulfate, MTX and pegaspargase. Patients with DS receive leucovorin calcium), augmented DI therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine, MTX. Patients with DS receive dexamethasone and leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
doxorubicin hydrochloride: Given IV or IT
cytarabine: Given IV or SC
dexamethasone: Given IV or PO
pegaspargase: Given IM
methotrexate: Given IM or IT
leucovorin calcium: Given PO
mercaptopurine: Given PO
cyclophosphamide: Given IV
thioguanine: Given PO
vincristine sulfate: Given IV
3
509
500
509
EG005
Group 2-SR-avg ALL, Arm III-combination Chemotherapy
Patients receive intensified consolidation therapy (cyclophosphamide, cytarabine, mercaptopurine and vincristine sulfate, pegaspargase, MTX. Patients with DS receive oral leucovorin calcium), standard interim maintenance therapy (vincristine sulfate, dexamethasone, mercaptopurine and MTX. Patients with DS receive leucovorin calcium), and standard DI therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine and MTX. Patients with DS receive dexamethasone, leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
doxorubicin hydrochloride: Given IV or IT
cytarabine: Given IV or SC
dexamethasone: Given IV or PO
pegaspargase: Given IM
methotrexate: Given IM or IT
leucovorin calcium: Given PO
mercaptopurine: Given PO
cyclophosphamide: Given IV
thioguanine: Given PO
vincristine sulfate: Given IV
0
246
237
246
EG006
Group 2-SR-avg ALL, Arm IV-combination Chemotherapy
Patients receive intensified consolidation therapy (cyclophosphamide, cytarabine, mercaptopurine and vincristine sulfate, pegaspargase, MTX. Patients with DS receive oral leucovorin calcium), augmented interim maintenance therapy (vincristine sulfate, MTX and pegaspargase. Patients with DS receive leucovorin calcium), and augmented DI therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine, MTX. Patients with DS receive dexamethasone and leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
doxorubicin hydrochloride: Given IV or IT
cytarabine: Given IV or SC
dexamethasone: Given IV or PO
pegaspargase: Given IM
methotrexate: Given IM or IT
leucovorin calcium: Given PO
mercaptopurine: Given PO
cyclophosphamide: Given IV
thioguanine: Given PO
vincristine sulfate: Given IV
1
247
234
247
EG007
Group 3-SR-high ALL, Combination Chemotherapy
Patients receive intensified consolidation therapy (cyclophosphamide, cytarabine, mercaptopurine & vincristine sulfate, pegaspargase, methotrexate. Patients with DS receive oral leucovorin calcium), augmented interim maintenance therapy (2 courses - vincristine sulfate, methotrexate and pegaspargase. Patients with DS receive leucovorin calcium), and augmented DI therapy (2 courses - vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine, methotrexate. Patients with DS receive dexamethasone and leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
doxorubicin hydrochloride: Given IV or IT
3-dimensional conformal radiation therapy: Some patients undergo cranial radiotherapy
cytarabine: Given IV or SC
dexamethasone: Given IV or PO
pegaspargase: Given IM
methotrexate: Given IM or IT
leucovorin calcium: Given PO
mercaptopurine
12
638
629
638
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anemia
Blood and lymphatic system disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0012 events2 affected931 at risk
EG0020 events0 affected931 at risk
EG0030 events0 affected501 at risk
EG0040 events0 affected509 at risk
EG0050 events0 affected246 at risk
EG0060 events0 affected247 at risk
EG0070 events0 affected638 at risk
Disseminated intravascular coagulation
Blood and lymphatic system disorders
CTCv4
EG0003 events3 affected1,306 at risk
EG0012 events2 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0012 events2 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Hemolysis
Blood and lymphatic system disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Cardiac arrest
Cardiac disorders
CTCv4
EG0002 events2 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Myocardial infarction
Cardiac disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Abdominal pain
Gastrointestinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Ascites
Gastrointestinal disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Cecal hemorrhage
Gastrointestinal disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Colitis
Gastrointestinal disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Colonic perforation
Gastrointestinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Diarrhea
Gastrointestinal disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Esophageal perforation
Gastrointestinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Esophagitis
Gastrointestinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Gastrointestinal disorders - Other, specify
Gastrointestinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Mucositis oral
Gastrointestinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Oral hemorrhage
Gastrointestinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Pancreatitis
Gastrointestinal disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Rectal hemorrhage
Gastrointestinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Rectal necrosis
Gastrointestinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Rectal pain
Gastrointestinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Small intestinal perforation
Gastrointestinal disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Typhlitis
Gastrointestinal disorders
CTCv4
EG0002 events2 affected1,306 at risk
EG0012 events2 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Death NOS
General disorders
CTCv4
EG0004 events4 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Edema trunk
General disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
General disorders and administration site conditions - Other, specify
General disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Multi-organ failure
General disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0012 events2 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Sudden death NOS
General disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Cholecystitis
Hepatobiliary disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Hepatic failure
Hepatobiliary disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Hepatobiliary disorders - Other, specify
Hepatobiliary disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Portal hypertension
Hepatobiliary disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Anaphylaxis
Immune system disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Appendicitis
Infections and infestations
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Appendicitis perforated
Infections and infestations
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Encephalitis infection
Infections and infestations
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Encephalomyelitis infection
Infections and infestations
CTCv4
EG0001 events1 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Enterocolitis infectious
Infections and infestations
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Infections and infestations - Other, specify
Infections and infestations
CTCv4
EG0006 events6 affected1,306 at risk
EG0014 events4 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Lung infection
Infections and infestations
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Pleural infection
Infections and infestations
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Sepsis
Infections and infestations
CTCv4
EG0001 events1 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Vascular access complication
Injury, poisoning and procedural complications
CTCv4
EG0001 events1 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Alanine aminotransferase increased
Investigations
CTCv4
EG0000 events0 affected1,306 at risk
EG0012 events2 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Alkaline phosphatase increased
Investigations
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Aspartate aminotransferase increased
Investigations
CTCv4
EG0000 events0 affected1,306 at risk
EG0013 events3 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Blood bilirubin increased
Investigations
CTCv4
EG0000 events0 affected1,306 at risk
EG0013 events3 affected931 at risk
EG0021 events1 affected931 at risk
EG003
CPK increased
Investigations
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Fibrinogen decreased
Investigations
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Investigations - Other, specify
Investigations
CTCv4
EG0001 events1 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Lipase increased
Investigations
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0022 events2 affected931 at risk
EG003
Neutrophil count decreased
Investigations
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Platelet count decreased
Investigations
CTCv4
EG0001 events1 affected1,306 at risk
EG0012 events2 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Serum amylase increased
Investigations
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0021 events1 affected931 at risk
EG003
White blood cell decreased
Investigations
CTCv4
EG0001 events1 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Acidosis
Metabolism and nutrition disorders
CTCv4
EG0002 events1 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Dehydration
Metabolism and nutrition disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Hyperglycemia
Metabolism and nutrition disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Hypoalbuminemia
Metabolism and nutrition disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Hypocalcemia
Metabolism and nutrition disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Hypoglycemia
Metabolism and nutrition disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Hypokalemia
Metabolism and nutrition disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Hyponatremia
Metabolism and nutrition disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Depressed level of consciousness
Nervous system disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Encephalopathy
Nervous system disorders
CTCv4
EG0003 events3 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Intracranial hemorrhage
Nervous system disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Nervous system disorders - Other, specify
Nervous system disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Peripheral motor neuropathy
Nervous system disorders
CTCv4
EG0002 events2 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Seizure
Nervous system disorders
CTCv4
EG0003 events3 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Confusion
Psychiatric disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Acute kidney injury
Renal and urinary disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Bladder perforation
Renal and urinary disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Adult respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0003 events3 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Apnea
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Bronchopulmonary hemorrhage
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Dyspnea
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0003 events3 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Hypotension
Vascular disorders
CTCv4
EG0004 events4 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Thromboembolic event
Vascular disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anemia
Blood and lymphatic system disorders
CTCv4
EG00088 events86 affected1,306 at risk
EG001438 events258 affected931 at risk
EG002356 events232 affected931 at risk
EG003183 events119 affected501 at risk
EG004213 events127 affected509 at risk
EG005113 events55 affected246 at risk
EG006150 events90 affected247 at risk
EG007466 events213 affected638 at risk
Blood and lymphatic system disorders - Other, specify
Blood and lymphatic system disorders
CTCv4
EG0002 events2 affected1,306 at risk
EG00116 events8 affected931 at risk
EG0028 events6 affected931 at risk
EG003
Bone marrow hypocellular
Blood and lymphatic system disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0012 events2 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Disseminated intravascular coagulation
Blood and lymphatic system disorders
CTCv4
EG0002 events2 affected1,306 at risk
EG0017 events6 affected931 at risk
EG0022 events2 affected931 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
CTCv4
EG000131 events130 affected1,306 at risk
EG0011,045 events531 affected931 at risk
EG0021,045 events555 affected931 at risk
EG003
Hemolysis
Blood and lymphatic system disorders
CTCv4
EG0002 events2 affected1,306 at risk
EG0016 events6 affected931 at risk
EG0023 events3 affected931 at risk
EG003
Hemolytic uremic syndrome
Blood and lymphatic system disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Spleen disorder
Blood and lymphatic system disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Cardiac arrest
Cardiac disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Cardiac disorders - Other, specify
Cardiac disorders
CTCv4
EG0003 events3 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Conduction disorder
Cardiac disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Left ventricular systolic dysfunction
Cardiac disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0023 events2 affected931 at risk
EG003
Mobitz (type) II atrioventricular block
Cardiac disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Myocarditis
Cardiac disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Pericardial effusion
Cardiac disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Sinus bradycardia
Cardiac disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Sinus tachycardia
Cardiac disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0014 events4 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Ventricular arrhythmia
Cardiac disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Ventricular tachycardia
Cardiac disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Wolff-Parkinson-White syndrome
Cardiac disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Ear and labyrinth disorders - Other, specify
Ear and labyrinth disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Ear pain
Ear and labyrinth disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0014 events2 affected931 at risk
EG0021 events1 affected931 at risk
EG003
External ear inflammation
Ear and labyrinth disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0021 events1 affected931 at risk
EG003
External ear pain
Ear and labyrinth disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Hearing impaired
Ear and labyrinth disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0022 events2 affected931 at risk
EG003
Middle ear inflammation
Ear and labyrinth disorders
CTCv4
EG0002 events2 affected1,306 at risk
EG0018 events8 affected931 at risk
EG0027 events6 affected931 at risk
EG003
Adrenal insufficiency
Endocrine disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0012 events2 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Endocrine disorders - Other, specify
Endocrine disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Blurred vision
Eye disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Extraocular muscle paresis
Eye disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Eye disorders - Other, specify
Eye disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Eye pain
Eye disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Glaucoma
Eye disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Keratitis
Eye disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Optic nerve disorder
Eye disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Photophobia
Eye disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Retinal detachment
Eye disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Retinopathy
Eye disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Vitreous hemorrhage
Eye disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Abdominal distension
Gastrointestinal disorders
CTCv4
EG0007 events7 affected1,306 at risk
EG00110 events10 affected931 at risk
EG0025 events5 affected931 at risk
EG003
Abdominal pain
Gastrointestinal disorders
CTCv4
EG00024 events24 affected1,306 at risk
EG00138 events32 affected931 at risk
EG00232 events27 affected931 at risk
EG003
Anal mucositis
Gastrointestinal disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0012 events2 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Anal necrosis
Gastrointestinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Anal pain
Gastrointestinal disorders
CTCv4
EG0002 events2 affected1,306 at risk
EG0012 events2 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Ascites
Gastrointestinal disorders
CTCv4
EG0002 events2 affected1,306 at risk
EG0016 events6 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Cecal hemorrhage
Gastrointestinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Colitis
Gastrointestinal disorders
CTCv4
EG0006 events5 affected1,306 at risk
EG0017 events7 affected931 at risk
EG0025 events5 affected931 at risk
EG003
Colonic fistula
Gastrointestinal disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Colonic hemorrhage
Gastrointestinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Colonic obstruction
Gastrointestinal disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Colonic perforation
Gastrointestinal disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0012 events2 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Colonic ulcer
Gastrointestinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0012 events2 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Constipation
Gastrointestinal disorders
CTCv4
EG00012 events12 affected1,306 at risk
EG00117 events15 affected931 at risk
EG00212 events12 affected931 at risk
EG003
Dental caries
Gastrointestinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Diarrhea
Gastrointestinal disorders
CTCv4
EG00024 events24 affected1,306 at risk
EG00191 events82 affected931 at risk
EG00267 events63 affected931 at risk
EG003
Duodenal hemorrhage
Gastrointestinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Duodenal perforation
Gastrointestinal disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Duodenal ulcer
Gastrointestinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Dyspepsia
Gastrointestinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Dysphagia
Gastrointestinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Enterocolitis
Gastrointestinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0014 events4 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Esophageal obstruction
Gastrointestinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Esophageal pain
Gastrointestinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Esophageal stenosis
Gastrointestinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Esophageal ulcer
Gastrointestinal disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0012 events2 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Esophagitis
Gastrointestinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0016 events6 affected931 at risk
EG0024 events4 affected931 at risk
EG003
Gastric fistula
Gastrointestinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Gastric perforation
Gastrointestinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Gastritis
Gastrointestinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0017 events7 affected931 at risk
EG0024 events4 affected931 at risk
EG003
Gastrointestinal disorders - Other, specify
Gastrointestinal disorders
CTCv4
EG0003 events3 affected1,306 at risk
EG0013 events3 affected931 at risk
EG0024 events4 affected931 at risk
EG003
Gastrointestinal fistula
Gastrointestinal disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Gastrointestinal pain
Gastrointestinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Gingival pain
Gastrointestinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Ileal hemorrhage
Gastrointestinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Ileal perforation
Gastrointestinal disorders
CTCv4
EG0003 events3 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Ileal ulcer
Gastrointestinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Ileus
Gastrointestinal disorders
CTCv4
EG00010 events10 affected1,306 at risk
EG0019 events8 affected931 at risk
EG0025 events5 affected931 at risk
EG003
Intra-abdominal hemorrhage
Gastrointestinal disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Lip pain
Gastrointestinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Lower gastrointestinal hemorrhage
Gastrointestinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Malabsorption
Gastrointestinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0012 events2 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Mucositis oral
Gastrointestinal disorders
CTCv4
EG0009 events9 affected1,306 at risk
EG00164 events62 affected931 at risk
EG00261 events53 affected931 at risk
EG003
Nausea
Gastrointestinal disorders
CTCv4
EG0006 events6 affected1,306 at risk
EG00114 events14 affected931 at risk
EG00210 events9 affected931 at risk
EG003
Oral hemorrhage
Gastrointestinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Oral pain
Gastrointestinal disorders
CTCv4
EG0003 events3 affected1,306 at risk
EG00113 events11 affected931 at risk
EG0025 events5 affected931 at risk
EG003
Pancreatic hemorrhage
Gastrointestinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Pancreatic necrosis
Gastrointestinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0012 events2 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Pancreatitis
Gastrointestinal disorders
CTCv4
EG00019 events18 affected1,306 at risk
EG0017 events6 affected931 at risk
EG0023 events2 affected931 at risk
EG003
Proctitis
Gastrointestinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0022 events1 affected931 at risk
EG003
Rectal fistula
Gastrointestinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0012 events2 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Rectal hemorrhage
Gastrointestinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Rectal mucositis
Gastrointestinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0013 events3 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Rectal pain
Gastrointestinal disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0014 events4 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Small intestinal mucositis
Gastrointestinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0012 events2 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Small intestinal perforation
Gastrointestinal disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Stomach pain
Gastrointestinal disorders
CTCv4
EG0003 events3 affected1,306 at risk
EG0014 events4 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Toothache
Gastrointestinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Typhlitis
Gastrointestinal disorders
CTCv4
EG0006 events6 affected1,306 at risk
EG0019 events9 affected931 at risk
EG0026 events6 affected931 at risk
EG003
Upper gastrointestinal hemorrhage
Gastrointestinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Vomiting
Gastrointestinal disorders
CTCv4
EG00011 events11 affected1,306 at risk
EG00153 events48 affected931 at risk
EG00242 events37 affected931 at risk
EG003
Chills
General disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Edema face
General disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Edema limbs
General disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0013 events2 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Edema trunk
General disorders
CTCv4
EG0003 events3 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Facial pain
General disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Fatigue
General disorders
CTCv4
EG0004 events4 affected1,306 at risk
EG00116 events16 affected931 at risk
EG0022 events2 affected931 at risk
EG003
Fever
General disorders
CTCv4
EG0006 events6 affected1,306 at risk
EG001104 events84 affected931 at risk
EG002128 events108 affected931 at risk
EG003
Flu like symptoms
General disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0012 events2 affected931 at risk
EG0024 events4 affected931 at risk
EG003
Gait disturbance
General disorders
CTCv4
EG0002 events2 affected1,306 at risk
EG0016 events6 affected931 at risk
EG0022 events2 affected931 at risk
EG003
General disorders and administration site conditions - Other, specify
General disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0016 events5 affected931 at risk
EG00213 events9 affected931 at risk
EG003
Hypothermia
General disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Injection site reaction
General disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Irritability
General disorders
CTCv4
EG0003 events2 affected1,306 at risk
EG0019 events6 affected931 at risk
EG0026 events4 affected931 at risk
EG003
Localized edema
General disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Multi-organ failure
General disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Non-cardiac chest pain
General disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0012 events2 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Pain
General disorders
CTCv4
EG0009 events9 affected1,306 at risk
EG00114 events14 affected931 at risk
EG00214 events14 affected931 at risk
EG003
Cholecystitis
Hepatobiliary disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0022 events2 affected931 at risk
EG003
Gallbladder obstruction
Hepatobiliary disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Gallbladder pain
Hepatobiliary disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Hepatic failure
Hepatobiliary disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Hepatic necrosis
Hepatobiliary disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Hepatic pain
Hepatobiliary disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Hepatobiliary disorders - Other, specify
Hepatobiliary disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG00110 events9 affected931 at risk
EG0025 events4 affected931 at risk
EG003
Portal hypertension
Hepatobiliary disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG00110 events10 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Allergic reaction
Immune system disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Anaphylaxis
Immune system disorders
CTCv4
EG0004 events4 affected1,306 at risk
EG00183 events76 affected931 at risk
EG0029 events9 affected931 at risk
EG003
Autoimmune disorder
Immune system disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Immune system disorders - Other, specify
Immune system disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0022 events2 affected931 at risk
EG003
Abdominal infection
Infections and infestations
CTCv4
EG0002 events2 affected1,306 at risk
EG0019 events8 affected931 at risk
EG00214 events14 affected931 at risk
EG003
Anorectal infection
Infections and infestations
CTCv4
EG0000 events0 affected1,306 at risk
EG0019 events9 affected931 at risk
EG0022 events2 affected931 at risk
EG003
Appendicitis
Infections and infestations
CTCv4
EG0002 events2 affected1,306 at risk
EG0014 events4 affected931 at risk
EG0025 events4 affected931 at risk
EG003
Appendicitis perforated
Infections and infestations
CTCv4
EG0002 events2 affected1,306 at risk
EG0013 events3 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Arteritis infective
Infections and infestations
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Bladder infection
Infections and infestations
CTCv4
EG0003 events3 affected1,306 at risk
EG00110 events10 affected931 at risk
EG00212 events10 affected931 at risk
EG003
Bone infection
Infections and infestations
CTCv4
EG0000 events0 affected1,306 at risk
EG0012 events2 affected931 at risk
EG0022 events2 affected931 at risk
EG003
Bronchial infection
Infections and infestations
CTCv4
EG0001 events1 affected1,306 at risk
EG00113 events13 affected931 at risk
EG00214 events13 affected931 at risk
EG003
Catheter related infection
Infections and infestations
CTCv4
EG0009 events8 affected1,306 at risk
EG00132 events29 affected931 at risk
EG00245 events37 affected931 at risk
EG003
Conjunctivitis infective
Infections and infestations
CTCv4
EG0000 events0 affected1,306 at risk
EG0012 events2 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Device related infection
Infections and infestations
CTCv4
EG0001 events1 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0025 events3 affected931 at risk
EG003
Encephalitis infection
Infections and infestations
CTCv4
EG0002 events2 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Encephalomyelitis infection
Infections and infestations
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Endocarditis infective
Infections and infestations
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0022 events2 affected931 at risk
EG003
Enterocolitis infectious
Infections and infestations
CTCv4
EG00012 events12 affected1,306 at risk
EG00138 events34 affected931 at risk
EG00239 events31 affected931 at risk
EG003
Esophageal infection
Infections and infestations
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Eye infection
Infections and infestations
CTCv4
EG0000 events0 affected1,306 at risk
EG0012 events2 affected931 at risk
EG0027 events6 affected931 at risk
EG003
Gum infection
Infections and infestations
CTCv4
EG0000 events0 affected1,306 at risk
EG0018 events8 affected931 at risk
EG0023 events3 affected931 at risk
EG003
Hepatic infection
Infections and infestations
CTCv4
EG0002 events2 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0023 events2 affected931 at risk
EG003
Hepatitis viral
Infections and infestations
CTCv4
EG0000 events0 affected1,306 at risk
EG0013 events3 affected931 at risk
EG0022 events2 affected931 at risk
EG003
Infections and infestations - Other, specify
Infections and infestations
CTCv4
EG000312 events227 affected1,306 at risk
EG001962 events489 affected931 at risk
EG002906 events463 affected931 at risk
EG003
Infective myositis
Infections and infestations
CTCv4
EG0001 events1 affected1,306 at risk
EG0012 events2 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Joint infection
Infections and infestations
CTCv4
EG0001 events1 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Kidney infection
Infections and infestations
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0023 events2 affected931 at risk
EG003
Laryngitis
Infections and infestations
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Lip infection
Infections and infestations
CTCv4
EG0000 events0 affected1,306 at risk
EG0012 events2 affected931 at risk
EG0024 events4 affected931 at risk
EG003
Lung infection
Infections and infestations
CTCv4
EG0004 events4 affected1,306 at risk
EG00191 events74 affected931 at risk
EG002103 events89 affected931 at risk
EG003
Lymph gland infection
Infections and infestations
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Meningitis
Infections and infestations
CTCv4
EG0003 events3 affected1,306 at risk
EG0012 events2 affected931 at risk
EG0024 events4 affected931 at risk
EG003
Mucosal infection
Infections and infestations
CTCv4
EG0001 events1 affected1,306 at risk
EG0015 events5 affected931 at risk
EG0026 events6 affected931 at risk
EG003
Nail infection
Infections and infestations
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0022 events2 affected931 at risk
EG003
Otitis externa
Infections and infestations
CTCv4
EG0000 events0 affected1,306 at risk
EG0014 events4 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Otitis media
Infections and infestations
CTCv4
EG0000 events0 affected1,306 at risk
EG00150 events41 affected931 at risk
EG00253 events48 affected931 at risk
EG003
Papulopustular rash
Infections and infestations
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0022 events2 affected931 at risk
EG003
Paronychia
Infections and infestations
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Penile infection
Infections and infestations
CTCv4
EG0001 events1 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Peripheral nerve infection
Infections and infestations
CTCv4
EG0000 events0 affected1,306 at risk
EG0012 events2 affected931 at risk
EG0022 events2 affected931 at risk
EG003
Peritoneal infection
Infections and infestations
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Pharyngitis
Infections and infestations
CTCv4
EG0000 events0 affected1,306 at risk
EG00114 events14 affected931 at risk
EG0027 events6 affected931 at risk
EG003
Pleural infection
Infections and infestations
CTCv4
EG0001 events1 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Rash pustular
Infections and infestations
CTCv4
EG0000 events0 affected1,306 at risk
EG0012 events2 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Salivary gland infection
Infections and infestations
CTCv4
EG0000 events0 affected1,306 at risk
EG0012 events2 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Sepsis
Infections and infestations
CTCv4
EG0001 events1 affected1,306 at risk
EG0015 events4 affected931 at risk
EG0027 events7 affected931 at risk
EG003
Sinusitis
Infections and infestations
CTCv4
EG0000 events0 affected1,306 at risk
EG00151 events44 affected931 at risk
EG00246 events38 affected931 at risk
EG003
Skin infection
Infections and infestations
CTCv4
EG0009 events8 affected1,306 at risk
EG00136 events32 affected931 at risk
EG00240 events37 affected931 at risk
EG003
Small intestine infection
Infections and infestations
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0025 events5 affected931 at risk
EG003
Soft tissue infection
Infections and infestations
CTCv4
EG0002 events2 affected1,306 at risk
EG0016 events5 affected931 at risk
EG0023 events3 affected931 at risk
EG003
Splenic infection
Infections and infestations
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0022 events1 affected931 at risk
EG003
Tooth infection
Infections and infestations
CTCv4
EG0000 events0 affected1,306 at risk
EG0012 events2 affected931 at risk
EG0025 events5 affected931 at risk
EG003
Tracheitis
Infections and infestations
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Upper respiratory infection
Infections and infestations
CTCv4
EG0005 events5 affected1,306 at risk
EG001107 events82 affected931 at risk
EG002118 events94 affected931 at risk
EG003
Urethral infection
Infections and infestations
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Urinary tract infection
Infections and infestations
CTCv4
EG0006 events4 affected1,306 at risk
EG00134 events31 affected931 at risk
EG00224 events19 affected931 at risk
EG003
Vaginal infection
Infections and infestations
CTCv4
EG0001 events1 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Vulval infection
Infections and infestations
CTCv4
EG0001 events1 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Wound infection
Infections and infestations
CTCv4
EG0003 events3 affected1,306 at risk
EG00114 events14 affected931 at risk
EG0026 events6 affected931 at risk
EG003
Fall
Injury, poisoning and procedural complications
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Fracture
Injury, poisoning and procedural complications
CTCv4
EG0001 events1 affected1,306 at risk
EG0013 events3 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Injury, poisoning and procedural complications - Other, specify
Injury, poisoning and procedural complications
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0024 events4 affected931 at risk
EG003
Intraoperative gastrointestinal injury
Injury, poisoning and procedural complications
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Intraoperative ocular injury
Injury, poisoning and procedural complications
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Intraoperative respiratory injury
Injury, poisoning and procedural complications
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Intraoperative venous injury
Injury, poisoning and procedural complications
CTCv4
EG0001 events1 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Postoperative hemorrhage
Injury, poisoning and procedural complications
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Prolapse of intestinal stoma
Injury, poisoning and procedural complications
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Vascular access complication
Injury, poisoning and procedural complications
CTCv4
EG0008 events8 affected1,306 at risk
EG0019 events7 affected931 at risk
EG00213 events9 affected931 at risk
EG003
Venous injury
Injury, poisoning and procedural complications
CTCv4
EG0001 events1 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Wound complication
Injury, poisoning and procedural complications
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Wound dehiscence
Injury, poisoning and procedural complications
CTCv4
EG0002 events2 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
CTCv4
EG00017 events17 affected1,306 at risk
EG00124 events23 affected931 at risk
EG0026 events6 affected931 at risk
EG003
Alanine aminotransferase increased
Investigations
CTCv4
EG000177 events174 affected1,306 at risk
EG0011,316 events453 affected931 at risk
EG0021,235 events443 affected931 at risk
EG003
Alkaline phosphatase increased
Investigations
CTCv4
EG0000 events0 affected1,306 at risk
EG0016 events5 affected931 at risk
EG00210 events9 affected931 at risk
EG003
Aspartate aminotransferase increased
Investigations
CTCv4
EG00060 events59 affected1,306 at risk
EG001335 events220 affected931 at risk
EG002278 events188 affected931 at risk
EG003
Blood bilirubin increased
Investigations
CTCv4
EG00020 events20 affected1,306 at risk
EG00190 events77 affected931 at risk
EG00289 events53 affected931 at risk
EG003
CPK increased
Investigations
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Cholesterol high
Investigations
CTCv4
EG0003 events3 affected1,306 at risk
EG0012 events2 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Creatinine increased
Investigations
CTCv4
EG0007 events7 affected1,306 at risk
EG0012 events2 affected931 at risk
EG0024 events4 affected931 at risk
EG003
Electrocardiogram QT corrected interval prolonged
Investigations
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Fibrinogen decreased
Investigations
CTCv4
EG00050 events50 affected1,306 at risk
EG00158 events41 affected931 at risk
EG00248 events40 affected931 at risk
EG003
GGT increased
Investigations
CTCv4
EG00029 events28 affected1,306 at risk
EG00179 events49 affected931 at risk
EG00222 events21 affected931 at risk
EG003
INR increased
Investigations
CTCv4
EG0005 events5 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0023 events3 affected931 at risk
EG003
Investigations - Other, specify
Investigations
CTCv4
EG0004 events4 affected1,306 at risk
EG00110 events8 affected931 at risk
EG00211 events9 affected931 at risk
EG003
Lipase increased
Investigations
CTCv4
EG00029 events28 affected1,306 at risk
EG00143 events38 affected931 at risk
EG00210 events7 affected931 at risk
EG003
Lymphocyte count decreased
Investigations
CTCv4
EG0009 events8 affected1,306 at risk
EG00194 events56 affected931 at risk
EG002117 events72 affected931 at risk
EG003
Neutrophil count decreased
Investigations
CTCv4
EG000172 events166 affected1,306 at risk
EG0012,226 events708 affected931 at risk
EG0022,182 events727 affected931 at risk
EG003
Platelet count decreased
Investigations
CTCv4
EG000111 events108 affected1,306 at risk
EG001405 events262 affected931 at risk
EG002297 events199 affected931 at risk
EG003
Serum amylase increased
Investigations
CTCv4
EG00017 events17 affected1,306 at risk
EG00119 events17 affected931 at risk
EG0027 events6 affected931 at risk
EG003
Weight gain
Investigations
CTCv4
EG0009 events9 affected1,306 at risk
EG00118 events17 affected931 at risk
EG00218 events16 affected931 at risk
EG003
Weight loss
Investigations
CTCv4
EG0007 events7 affected1,306 at risk
EG00112 events11 affected931 at risk
EG0028 events7 affected931 at risk
EG003
White blood cell decreased
Investigations
CTCv4
EG000110 events106 affected1,306 at risk
EG001765 events304 affected931 at risk
EG002903 events345 affected931 at risk
EG003
Acidosis
Metabolism and nutrition disorders
CTCv4
EG0004 events4 affected1,306 at risk
EG0015 events5 affected931 at risk
EG0024 events4 affected931 at risk
EG003
Alkalosis
Metabolism and nutrition disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0012 events2 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Anorexia
Metabolism and nutrition disorders
CTCv4
EG00016 events16 affected1,306 at risk
EG00151 events42 affected931 at risk
EG00251 events35 affected931 at risk
EG003
Dehydration
Metabolism and nutrition disorders
CTCv4
EG00019 events19 affected1,306 at risk
EG00167 events54 affected931 at risk
EG00262 events51 affected931 at risk
EG003
Glucose intolerance
Metabolism and nutrition disorders
CTCv4
EG0007 events7 affected1,306 at risk
EG0015 events4 affected931 at risk
EG0024 events3 affected931 at risk
EG003
Hypercalcemia
Metabolism and nutrition disorders
CTCv4
EG0005 events5 affected1,306 at risk
EG0015 events5 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Hyperglycemia
Metabolism and nutrition disorders
CTCv4
EG00077 events77 affected1,306 at risk
EG00157 events52 affected931 at risk
EG00250 events45 affected931 at risk
EG003
Hyperkalemia
Metabolism and nutrition disorders
CTCv4
EG00022 events22 affected1,306 at risk
EG00119 events19 affected931 at risk
EG00219 events17 affected931 at risk
EG003
Hypermagnesemia
Metabolism and nutrition disorders
CTCv4
EG0002 events2 affected1,306 at risk
EG0014 events4 affected931 at risk
EG0022 events2 affected931 at risk
EG003
Hypernatremia
Metabolism and nutrition disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0014 events4 affected931 at risk
EG0022 events2 affected931 at risk
EG003
Hypertriglyceridemia
Metabolism and nutrition disorders
CTCv4
EG0008 events8 affected1,306 at risk
EG0019 events8 affected931 at risk
EG0022 events2 affected931 at risk
EG003
Hyperuricemia
Metabolism and nutrition disorders
CTCv4
EG0006 events6 affected1,306 at risk
EG0013 events3 affected931 at risk
EG0023 events3 affected931 at risk
EG003
Hypoalbuminemia
Metabolism and nutrition disorders
CTCv4
EG00026 events26 affected1,306 at risk
EG00175 events66 affected931 at risk
EG00237 events34 affected931 at risk
EG003
Hypocalcemia
Metabolism and nutrition disorders
CTCv4
EG00038 events38 affected1,306 at risk
EG00136 events35 affected931 at risk
EG00235 events34 affected931 at risk
EG003
Hypoglycemia
Metabolism and nutrition disorders
CTCv4
EG0004 events4 affected1,306 at risk
EG00173 events61 affected931 at risk
EG00219 events16 affected931 at risk
EG003
Hypokalemia
Metabolism and nutrition disorders
CTCv4
EG00070 events70 affected1,306 at risk
EG001127 events107 affected931 at risk
EG002135 events115 affected931 at risk
EG003
Hypomagnesemia
Metabolism and nutrition disorders
CTCv4
EG0003 events3 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Hyponatremia
Metabolism and nutrition disorders
CTCv4
EG00078 events77 affected1,306 at risk
EG00190 events75 affected931 at risk
EG00268 events62 affected931 at risk
EG003
Hypophosphatemia
Metabolism and nutrition disorders
CTCv4
EG00020 events20 affected1,306 at risk
EG00113 events13 affected931 at risk
EG00221 events21 affected931 at risk
EG003
Metabolism and nutrition disorders - Other, specify
Metabolism and nutrition disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Obesity
Metabolism and nutrition disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0013 events2 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Tumor lysis syndrome
Metabolism and nutrition disorders
CTCv4
EG00014 events14 affected1,306 at risk
EG0013 events3 affected931 at risk
EG0022 events2 affected931 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
CTCv4
EG0004 events4 affected1,306 at risk
EG0018 events8 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Avascular necrosis
Musculoskeletal and connective tissue disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG00111 events7 affected931 at risk
EG0023 events3 affected931 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
CTCv4
EG0008 events8 affected1,306 at risk
EG00112 events11 affected931 at risk
EG00212 events12 affected931 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
CTCv4
EG0005 events5 affected1,306 at risk
EG00111 events10 affected931 at risk
EG0026 events6 affected931 at risk
EG003
Buttock pain
Musculoskeletal and connective tissue disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Chest wall pain
Musculoskeletal and connective tissue disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Generalized muscle weakness
Musculoskeletal and connective tissue disorders
CTCv4
EG0002 events2 affected1,306 at risk
EG0016 events5 affected931 at risk
EG0025 events5 affected931 at risk
EG003
Joint effusion
Musculoskeletal and connective tissue disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0012 events2 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Muscle weakness lower limb
Musculoskeletal and connective tissue disorders
CTCv4
EG00016 events16 affected1,306 at risk
EG00110 events9 affected931 at risk
EG0027 events7 affected931 at risk
EG003
Muscle weakness right-sided
Musculoskeletal and connective tissue disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Muscle weakness trunk
Musculoskeletal and connective tissue disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Muscle weakness upper limb
Musculoskeletal and connective tissue disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Musculoskeletal and connective tissue disorder - Other, specify
Musculoskeletal and connective tissue disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
CTCv4
EG0003 events3 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Myositis
Musculoskeletal and connective tissue disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0022 events2 affected931 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0022 events2 affected931 at risk
EG003
Osteoporosis
Musculoskeletal and connective tissue disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
CTCv4
EG00014 events14 affected1,306 at risk
EG00138 events34 affected931 at risk
EG00225 events22 affected931 at risk
EG003
Soft tissue necrosis lower limb
Musculoskeletal and connective tissue disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Soft tissue necrosis upper limb
Musculoskeletal and connective tissue disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Myelodysplastic syndrome
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Treatment related secondary malignancy
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Tumor pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Abducens nerve disorder
Nervous system disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0013 events2 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Arachnoiditis
Nervous system disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0012 events2 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Ataxia
Nervous system disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Cerebrospinal fluid leakage
Nervous system disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Cognitive disturbance
Nervous system disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Depressed level of consciousness
Nervous system disorders
CTCv4
EG0003 events3 affected1,306 at risk
EG0013 events3 affected931 at risk
EG0022 events2 affected931 at risk
EG003
Dizziness
Nervous system disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0022 events2 affected931 at risk
EG003
Dysphasia
Nervous system disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0015 events5 affected931 at risk
EG0023 events3 affected931 at risk
EG003
Encephalopathy
Nervous system disorders
CTCv4
EG0005 events5 affected1,306 at risk
EG0017 events6 affected931 at risk
EG0027 events7 affected931 at risk
EG003
Extrapyramidal disorder
Nervous system disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Facial muscle weakness
Nervous system disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Facial nerve disorder
Nervous system disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Headache
Nervous system disorders
CTCv4
EG00010 events10 affected1,306 at risk
EG00119 events16 affected931 at risk
EG00224 events21 affected931 at risk
EG003
Hydrocephalus
Nervous system disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0012 events2 affected931 at risk
EG0022 events2 affected931 at risk
EG003
Hypoglossal nerve disorder
Nervous system disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
IVth nerve disorder
Nervous system disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Intracranial hemorrhage
Nervous system disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Ischemia cerebrovascular
Nervous system disorders
CTCv4
EG0003 events3 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Leukoencephalopathy
Nervous system disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Memory impairment
Nervous system disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Nervous system disorders - Other, specify
Nervous system disorders
CTCv4
EG0008 events8 affected1,306 at risk
EG0013 events3 affected931 at risk
EG0024 events4 affected931 at risk
EG003
Neuralgia
Nervous system disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0025 events4 affected931 at risk
EG003
Oculomotor nerve disorder
Nervous system disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Peripheral motor neuropathy
Nervous system disorders
CTCv4
EG00038 events38 affected1,306 at risk
EG001105 events68 affected931 at risk
EG00289 events52 affected931 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
CTCv4
EG00029 events29 affected1,306 at risk
EG00194 events57 affected931 at risk
EG00278 events41 affected931 at risk
EG003
Recurrent laryngeal nerve palsy
Nervous system disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Seizure
Nervous system disorders
CTCv4
EG00012 events12 affected1,306 at risk
EG0019 events9 affected931 at risk
EG00212 events11 affected931 at risk
EG003
Sinus pain
Nervous system disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Somnolence
Nervous system disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Syncope
Nervous system disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0014 events3 affected931 at risk
EG0022 events2 affected931 at risk
EG003
Tremor
Nervous system disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Trigeminal nerve disorder
Nervous system disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0022 events2 affected931 at risk
EG003
Vagus nerve disorder
Nervous system disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Vasovagal reaction
Nervous system disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Agitation
Psychiatric disorders
CTCv4
EG0007 events7 affected1,306 at risk
EG00111 events8 affected931 at risk
EG00210 events10 affected931 at risk
EG003
Anxiety
Psychiatric disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0014 events3 affected931 at risk
EG0022 events2 affected931 at risk
EG003
Confusion
Psychiatric disorders
CTCv4
EG0002 events2 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Depression
Psychiatric disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0012 events2 affected931 at risk
EG0023 events3 affected931 at risk
EG003
Insomnia
Psychiatric disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0012 events2 affected931 at risk
EG0023 events3 affected931 at risk
EG003
Personality change
Psychiatric disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG00110 events6 affected931 at risk
EG00211 events8 affected931 at risk
EG003
Psychiatric disorders - Other, specify
Psychiatric disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Psychosis
Psychiatric disorders
CTCv4
EG0002 events2 affected1,306 at risk
EG00111 events10 affected931 at risk
EG0028 events5 affected931 at risk
EG003
Suicidal ideation
Psychiatric disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Acute kidney injury
Renal and urinary disorders
CTCv4
EG0007 events7 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0023 events3 affected931 at risk
EG003
Bladder spasm
Renal and urinary disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Cystitis noninfective
Renal and urinary disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Hematuria
Renal and urinary disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0012 events2 affected931 at risk
EG0022 events2 affected931 at risk
EG003
Proteinuria
Renal and urinary disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Renal and urinary disorders - Other, specify
Renal and urinary disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0012 events2 affected931 at risk
EG0024 events3 affected931 at risk
EG003
Renal calculi
Renal and urinary disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Renal colic
Renal and urinary disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Renal hemorrhage
Renal and urinary disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Urinary retention
Renal and urinary disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0023 events3 affected931 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
CTCv4
EG0004 events4 affected1,306 at risk
EG0019 events6 affected931 at risk
EG0023 events3 affected931 at risk
EG003
Urinary tract pain
Renal and urinary disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0013 events2 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Penile pain
Reproductive system and breast disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Scrotal pain
Reproductive system and breast disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Testicular pain
Reproductive system and breast disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Adult respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0019 events8 affected931 at risk
EG0022 events2 affected931 at risk
EG003
Apnea
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0014 events3 affected931 at risk
EG0022 events2 affected931 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0002 events2 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0022 events2 affected931 at risk
EG003
Bronchial obstruction
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0012 events1 affected931 at risk
EG0023 events3 affected931 at risk
EG003
Bronchopulmonary hemorrhage
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0002 events2 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0002 events2 affected1,306 at risk
EG00111 events11 affected931 at risk
EG00212 events9 affected931 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG00113 events13 affected931 at risk
EG00216 events16 affected931 at risk
EG003
Dyspnea
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0014 events4 affected931 at risk
EG0025 events5 affected931 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0014 events4 affected931 at risk
EG0024 events3 affected931 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
CTCv4
EG00015 events15 affected1,306 at risk
EG00132 events30 affected931 at risk
EG00226 events25 affected931 at risk
EG003
Laryngeal edema
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0012 events2 affected931 at risk
EG0024 events4 affected931 at risk
EG003
Laryngeal mucositis
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Laryngeal obstruction
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Pharyngeal mucositis
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Pharyngeal stenosis
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Pharyngolaryngeal pain
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0014 events4 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0009 events9 affected1,306 at risk
EG00113 events13 affected931 at risk
EG0024 events4 affected931 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0006 events6 affected1,306 at risk
EG00123 events21 affected931 at risk
EG00221 events20 affected931 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0002 events2 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Pulmonary edema
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Pulmonary hypertension
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0023 events3 affected931 at risk
EG003
Respiratory, thoracic and mediastinal disorders - Other, specify
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0018 events8 affected931 at risk
EG00216 events15 affected931 at risk
EG003
Sinus disorder
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0012 events2 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Sore throat
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Stridor
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Tracheal fistula
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Voice alteration
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Erythema multiforme
Skin and subcutaneous tissue disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0011 events1 affected931 at risk
EG0023 events2 affected931 at risk
EG003
Pain of skin
Skin and subcutaneous tissue disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Palmar-plantar erythrodysesthesia syndrome
Skin and subcutaneous tissue disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0022 events2 affected931 at risk
EG003
Photosensitivity
Skin and subcutaneous tissue disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0010 events0 affected931 at risk
EG0020 events0 affected931 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
CTCv4
EG0000 events0 affected1,306 at risk
EG0016 events6 affected931 at risk
EG0022 events2 affected931 at risk
EG003
Purpura
Skin and subcutaneous tissue disorders
CTCv4
EG0001 events1 affected1,306 at risk
EG0013 events3 affected931 at risk
EG0021 events1 affected931 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
CTCv4
EG0004 events4 affected1,306 at risk
EG00111 events10 affected931 at risk
EG0029 events7 affected931 at risk
EG003
Skin and subcutaneous tissue disorders - Other, specify
Physical Functioning: Parents of 160 SR-ALL patients enrolled on Children's Oncology Group (COG) therapeutic trial AALL0331 at 31 sites completed the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales (physical, emotional and social functioning) and Family Assessment Device-General Functioning (FAD-GF) at 1, 6 and 12 months after diagnosis, and 3 months post-therapy.
Mixed Models Analysis
Odds Ratio (OR)
5.17
2-Sided
95
1.61
16.63
Odds Ratios in this Statistical Analysis corresponds to all four time points.
Superiority or Other (legacy)
OG000
Social Functioning: Parents of 160 SR-ALL patients enrolled on Children's Oncology Group (COG) therapeutic trial AALL0331 at 31 sites completed the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales (physical, emotional and social functioning) and Family Assessment Device-General Functioning (FAD-GF) at 1, 6 and 12 months after diagnosis, and 3 months post-therapy.
Mixed Models Analysis
Odds Ratio (OR)
1.99
2-Sided
95
1.21
3.27
Odds Ratios in this Statistical Analysis corresponds to all four time points
Superiority or Other (legacy)
OG000
Parents of 160 SR-ALL patients enrolled on Children's Oncology Group (COG) therapeutic trial AALL0331 at 31 sites completed the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales (physical, emotional and social functioning) and Family Assessment Device-General Functioning (FAD-GF) at 1, 6 and 12 months after diagnosis, and 3 months post-therapy.
Mixed Models Analysis
Odds Ratio (OR)
1.85
2-Sided
95
1.03
3.34
Odds Ratios in this Statistical Analysis corresponds to all four time points
Superiority or Other (legacy)
All patients receive cytarabine intrathecally (IT) on day 1; vincristine IV on days 1, 8, 15, and 22; dexamethasone IV or orally (PO) twice daily (BID) on days 1-28; pegaspargase intramuscularly (IM) (may give IV over 1 to 2 hours) on day 4, 5, or 6; and methotrexate IT on days 8 and 29 (and days 15 and 22 for patients with CNS3 disease). Patients with Down syndrome (DS) receive leucovorin calcium PO at 48 and 60 hours after each dose of methotrexate IT. Patients are assessed for response on day 29. Patients with M1 bone marrow AND minimal residual disease (MRD) < 0.1% OR MRD >= 0.1% and < 1% proceed to therapy in part II. Patients with M2 bone marrow OR M1 bone marrow AND MRD >= 1% proceed to extended induction therapy. Patients with M3 bone marrow are removed from the study.
cytarabine: Given IV or SC
dexamethasone: Given IV or PO
pegaspargase: Given IM
methotrexate: Given IM or IT
vincristine sulfate: Given IV
Units
Counts
Participants
OG0004614
OG001367
Title
Denominators
Categories
Title
Measurements
OG00091.39(90.41 to 92.37)
OG00179.86(75.04 to 84.68)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
4981 eligible evaluable patients enrolled on AALL0331 had MRD evaluation at Day 29 of induction. MRD status defined as negative (<0.1%) or positive (>=0.1%). MRD status ( positive vs. negative) was correlated with EFS using Cox regression analysis.
Regression, Cox
Hazard Ratio (HR)
2.542
2-Sided
95
1.974
3.273
Superiority or Other (legacy)
All patients receive cytarabine intrathecally (IT) on day 1; vincristine IV on days 1, 8, 15, and 22; dexamethasone IV or orally (PO) twice daily (BID) on days 1-28; pegaspargase intramuscularly (IM) (may give IV over 1 to 2 hours) on day 4, 5, or 6; and methotrexate IT on days 8 and 29 (and days 15 and 22 for patients with CNS3 disease). Patients with Down syndrome (DS) receive leucovorin calcium PO at 48 and 60 hours after each dose of methotrexate IT. Patients are assessed for response on day 29. Patients with M1 bone marrow AND minimal residual disease (MRD) < 0.1% OR MRD >= 0.1% and < 1% proceed to therapy in part II. Patients with M2 bone marrow OR M1 bone marrow AND MRD >= 1% proceed to extended induction therapy. Patients with M3 bone marrow are removed from the study.
cytarabine: Given IV or SC
dexamethasone: Given IV or PO
pegaspargase: Given IM
methotrexate: Given IM or IT
vincristine sulfate: Given IV
Units
Counts
Participants
OG0004614
OG001367
Title
Denominators
Categories
Title
Measurements
OG00097.07(96.5 to 97.68)
OG00190.47(86.92 to 94.02)
All Patients for Induction, MRD Positive
All patients receive cytarabine intrathecally (IT) on day 1; vincristine IV on days 1, 8, 15, and 22; dexamethasone IV or orally (PO) twice daily (BID) on days 1-28; pegaspargase intramuscularly (IM) (may give IV over 1 to 2 hours) on day 4, 5, or 6; and methotrexate IT on days 8 and 29 (and days 15 and 22 for patients with CNS3 disease). Patients with Down syndrome (DS) receive leucovorin calcium PO at 48 and 60 hours after each dose of methotrexate IT. Patients are assessed for response on day 29. Patients with M1 bone marrow AND minimal residual disease (MRD) < 0.1% OR MRD >= 0.1% and < 1% proceed to therapy in part II. Patients with M2 bone marrow OR M1 bone marrow AND MRD >= 1% proceed to extended induction therapy. Patients with M3 bone marrow are removed from the study.
cytarabine: Given IV or SC
dexamethasone: Given IV or PO
pegaspargase: Given IM
methotrexate: Given IM or IT
vincristine sulfate: Given IV
Units
Counts
Participants
OG0004609
OG001362
Title
Denominators
Categories
Title
Measurements
OG0004378
OG001258
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
MRD status ( positive vs. negative) was correlated with Early Marrow Status (M1 vs M2/M3) using Chi Square test.
Chi-squared
Odds Ratio (OR)
0.131
2-Sided
95
0.101
0.17
Superiority or Other (legacy)
Units
Counts
Participants
OG000159
Title
Denominators
Categories
At 1 month after diagnosis
ParticipantsOG000159
Title
Measurements
OG00025.2(18.5 to 31.9)
At 3 months post-therapy
ParticipantsOG00096
Title
Measurements
OG00024.0(16.0 to 32.0)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Parents of 159 SR-ALL patients enrolled on Children's Oncology Group (COG) therapeutic trial AALL0331 at 31 sites completed the BASC-2 Anxiety Scale at 1 month after diagnosis, and 3 months post-therapy. Of these 159 had data at 1 month after diagnosis and 96 at 3 months post therapy.
Regression, Logistic
Odds Ratio (OR)
4.1
2-Sided
95
1.31
12.73
Other
Units
Counts
Participants
OG000636
Title
Denominators
Categories
Title
Measurements
OG00085.58(85.55 to 85.61)
OG001
Group 2-SR-avg ALL, Arm I-combination Chemotherapy
Patients receive standard consolidation therapy (vincristine sulfate, mercaptopurine and methotrexate. Patients with Down syndrome (DS) receive leucovorin calcium), standard interim maintenance therapy (vincristine sulfate, dexamethasone, mercaptopurine and methotrexate. Patients with DS receive leucovorin calcium), and standard delayed intensification (DI) therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine and methotrexate. Patients with DS receive dexamethasone, leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.