NHL16: Study For Newly Diagnosed Patients With Acute Lymp... | NCT01451515

ID	Type	Description	Link
NCI-2012-00496	Registry Identifier	NCI Clinical Trial Registration Program

Name	Class
National University of Singapore	OTHER

Description Module

Detailed Description

TREATMENT PLAN

Treatment will consist of 3 main phases: remission induction, consolidation [only for patients with any central nervous system (CNS) disease and/or testicular involvement], and continuation.

Induction (6-7 weeks).
Consolidation for participants with CNS involvement or those with testicular disease only (10 weeks).
Reintensification - Participants with residual disease any time after induction therapy may receive 1-2 cycles of re-intensification therapy and may proceed to allogeneic stem cell transplant if suitable donor is available.
Continuation Therapy (98-120 weeks).
Intrathecal Chemotherapy (days 1 and 15; if needed also on days 8 and 22)

TREATMENT SCHEME

T lymphoblastic lymphoma: bone marrow/peripheral blood (BM/PB) involvement (MDD/MRD): Diagnosis: less than 1%; Day 8: +/- (Stratum 1)

Induction
- Single dose of Cyclophosphamide
- Steroid: prednisone
Continuation: 98 weeks

T lymphoblastic lymphoma: BM/PB involvement (MDD/MRD): Diagnosis: equal to or greater than 1%; Day 8: - (Stratum 2)

Induction
- Fractionated Cyclophosphamide
- Steroid: prednisone
Continuation : 98 weeks

T lymphoblastic lymphoma: BM/PB involvement (MDD/MRD): Diagnosis: equal to or greater than 1%; Day 8: + (Stratum 3)

Induction
- Fractionated Cyclophosphamide
- Steroid: prednisone and dexamethasone
Continuation: 120 weeks

B lymphoblastic lymphoma: Stage I-III (Stratum 1)

Induction
- Single dose of Cyclophosphamide
- Steroid: prednisone
Continuation: 98 weeks

B lymphoblastic lymphoma: Stage IV or testicular (Stratum 2)

Induction
- Fractionated Cyclophosphamide
- Steroid: prednisone
Continuation: 98 weeks

Patients with CNS or testicular involvement will receive Consolidation therapy prior to continuation therapy and receive extended maintenance therapy (120 weeks).

Any patient with detectable disease (MRD, bone marrow or biopsy of residual mass) at the end of induction may be considered for reintensification and/or hematopoietic stem cell transplantation (HSCT).

Label	Type	Description	Intervention Names
Treatment	Experimental	Patients will undergo treatment as described in the intervention section. Interventions include: Remission induction: prednisone, vincristine, daunorubicin, PEG-asparaginase (or Erwinia asparaginase), IT-MHA (Methotrexate, hydrocortisone, and cytarabine), cyclophosphamide, cytarabine, thioguanine Consolidation: PEG-asparaginase, High-dose methotrexate (HD-MTX), mercaptopurine Postremission continuation: Dexamethasone, doxorubicin, vincristine, mercaptopurine, PEG-asparaginase, cyclophosphamide, cytarabine, methotrexate Reintensification: dexamethasone, cytarabine, etoposide, PEG-asparaginase, clofarabine, cyclophosphamide All patients receive IT-MHA on days 1 and 15. Some patients also receive additional IT-MHA on days 8 and 22.	Drug: Prednisone Drug: Vincristine Drug: Daunorubicin Drug: PEG-asparaginase Drug: Erwinia asparaginase Drug: Doxorubicin Drug: Cyclophosphamide Drug: Cytarabine Drug: Thioguanine Drug: Clofarabine Drug: Methotrexate Drug: Mercaptopurine Drug: Dexamethasone Drug: Hydrocortisone Drug: Etoposide

Name	Type	Description	Arm Group Labels	Other Names
Prednisone	Drug	Given orally (PO).	Treatment	Prednisolone

Measure	Description	Time Frame
Probability of Event-free Survival (EFS)	For EFS, relapse and second malignancies are considered as failures in addition to death in complete remission. The time to EFS will be set to 0 for patients who fail to achieve complete remission. Kaplan-Meier estimates of the OS and EFS curves are computed, along with estimates of standard errors by Peto's method. Please note the unit of measurement of probabilities are percentages.	Two years post therapy.

Measure	Description	Time Frame
Probability of Overall Survival (OS)	For OS, only deaths are considered failures for OS. Kaplan-Meier estimates of the OS curves are computed along with estimates of standard errors by Peto's method. Please note the unit of measurement of probabilities are percentages.	Two years post therapy.
Minimal Disseminated Disease (MDD)

Eligibility Module

Name	Affiliation	Role
Hiroto Inaba, MD,PhD	St. Jude Children's Research Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Rady Children's Hospital San Diego		San Diego	California	92123	United States
St. Jude Children's Research Hospital

Label	URL
St. Jude Children's Research Hospital	View source
Clinical Trials Open at St. Jude	View source

ID	Title	Description
FG000	Stratum 1	Minimal disseminated disease (MDD) <1% at diagnosis in T-lymphoblastic lymphoma No bone marrow involvement microscopically at diagnosis in B-lymphoblastic lymphoma Patients should not have: Any CNS involvement: CNS-3 status (i.e., ≥5 WBC/µL of CSF with blasts or cranial nerve palsy), CNS-2 status (<5 WBC/µL of CSF with blasts) or traumatic LP (>10 RBC/µL of CSF with blasts) Overt testicular involvement (evidenced by ultrasonogram).

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Mar 27, 2015

ID	Title	Description
BG000	Stratum 1	Minimal disseminated disease (MDD) <1% at diagnosis in T-lymphoblastic lymphoma No bone marrow involvement microscopically at diagnosis in B-lymphoblastic lymphoma Patients should not have: Any CNS involvement: CNS-3 status (i.e., ≥5 WBC/µL of CSF with blasts or cranial nerve palsy), CNS-2 status (<5 WBC/µL of CSF with blasts) or traumatic LP (>10 RBC/µL of CSF with blasts) Overt testicular involvement (evidenced by ultrasonogram).
BG001	Stratum 2	MDD ≥1% and MRD negative (<0.01%) on day 8 in T-lymphoblastic lymphoma Bone marrow involvement microscopically present at diagnosis in B-lymphoblastic lymphoma Any CNS involvement: CNS-3 status (i.e., ≥5 WBC/µL of CSF with blasts or cranial nerve palsy), CNS-2 status (<5 WBC/µL of CSF with blasts) or traumatic LP (>10 RBC/µL of CSF with blasts) but does not fulfill the criteria of stratum 3 Overt testicular involvement (evidenced by ultrasonogram) but does not fulfill the criteria of stratum 3
BG002	Stratum 3	Any patients with MDD ≥1% and MRD positive (≥0.01%) on day 8 in T-lymphoblastic lymphoma
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG00012 BG0017 BG0024 BG00323

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

Probability of Event-free Survival (EFS)

For EFS, relapse and second malignancies are considered as failures in addition to death in complete remission. The time to EFS will be set to 0 for patients who fail to achieve complete remission. Kaplan-Meier estimates of the OS and EFS curves are computed, along with estimates of standard errors by Peto's method.

Please note the unit of measurement of probabilities are percentages.

Posted

Number

95% Confidence Interval

percentage of event-free patients

Two years post therapy.

ID	Title	Description
OG000	Stratum 1	Minimal disseminated disease (MDD) <1% at diagnosis in T-lymphoblastic lymphoma No bone marrow involvement microscopically at diagnosis in B-lymphoblastic lymphoma Patients should not have: Any CNS involvement: CNS-3 status (i.e., ≥5 WBC/µL of CSF with blasts or cranial nerve palsy), CNS-2 status (<5 WBC/µL of CSF with blasts) or traumatic LP (>10 RBC/µL of CSF with blasts) Overt testicular involvement (evidenced by ultrasonogram).
OG001	Stratum 2	MDD ≥1% and MRD negative (<0.01%) on day 8 in T-lymphoblastic lymphoma Bone marrow involvement microscopically present at diagnosis in B-lymphoblastic lymphoma Any CNS involvement: CNS-3 status (i.e., ≥5 WBC/µL of CSF with blasts or cranial nerve palsy), CNS-2 status (<5 WBC/µL of CSF with blasts) or traumatic LP (>10 RBC/µL of CSF with blasts) but does not fulfill the criteria of stratum 3 Overt testicular involvement (evidenced by ultrasonogram) but does not fulfill the criteria of stratum 3
OG002	Stratum 3	Any patients with MDD ≥1% and MRD positive (≥0.01%) on day 8 in T-lymphoblastic lymphoma
OG003	All Enrollments	Twenty-three (23) eligible patients

Units	Counts
Participants	OG00012 OG0017 OG0024 OG003

Title

Denominators

Categories

Title	Measurements
	OG00091.7(53.9 to 98.8) OG00171.4(25.8 to 92.0) OG002100(100 to 100) OG003

Secondary

Probability of Overall Survival (OS)

For OS, only deaths are considered failures for OS. Kaplan-Meier estimates of the OS curves are computed along with estimates of standard errors by Peto's method.

Please note the unit of measurement of probabilities are percentages.

Posted

Number

95% Confidence Interval

percentage of patients alive

Two years post therapy.

ID	Title	Description
OG000	Stratum 1	Minimal disseminated disease (MDD) <1% at diagnosis in T-lymphoblastic lymphoma No bone marrow involvement microscopically at diagnosis in B-lymphoblastic lymphoma Patients should not have: Any CNS involvement: CNS-3 status (i.e., ≥5 WBC/µL of CSF with blasts or cranial nerve palsy), CNS-2 status (<5 WBC/µL of CSF with blasts) or traumatic LP (>10 RBC/µL of CSF with blasts) Overt testicular involvement (evidenced by ultrasonogram).
OG001	Stratum 2	MDD ≥1% and MRD negative (<0.01%) on day 8 in T-lymphoblastic lymphoma Bone marrow involvement microscopically present at diagnosis in B-lymphoblastic lymphoma Any CNS involvement: CNS-3 status (i.e., ≥5 WBC/µL of CSF with blasts or cranial nerve palsy), CNS-2 status (<5 WBC/µL of CSF with blasts) or traumatic LP (>10 RBC/µL of CSF with blasts) but does not fulfill the criteria of stratum 3 Overt testicular involvement (evidenced by ultrasonogram) but does not fulfill the criteria of stratum 3
OG002

Secondary

Minimal Disseminated Disease (MDD)

Detectable disease in bone marrow or blood: A binary measure, positive (detectable), negative (non-detectable)

Fourteen patients had MDD data at diagnosis.

Posted

Number

participants

At Diagnosis

ID	Title	Description
OG000	Stratum 1	Minimal disseminated disease (MDD) <1% at diagnosis in T-lymphoblastic lymphoma No bone marrow involvement microscopically at diagnosis in B-lymphoblastic lymphoma Patients should not have: Any CNS involvement: CNS-3 status (i.e., ≥5 WBC/µL of CSF with blasts or cranial nerve palsy), CNS-2 status (<5 WBC/µL of CSF with blasts) or traumatic LP (>10 RBC/µL of CSF with blasts) Overt testicular involvement (evidenced by ultrasonogram).
OG001	Stratum 2	MDD ≥1% and MRD negative (<0.01%) on day 8 in T-lymphoblastic lymphoma Bone marrow involvement microscopically present at diagnosis in B-lymphoblastic lymphoma Any CNS involvement: CNS-3 status (i.e., ≥5 WBC/µL of CSF with blasts or cranial nerve palsy), CNS-2 status (<5 WBC/µL of CSF with blasts) or traumatic LP (>10 RBC/µL of CSF with blasts) but does not fulfill the criteria of stratum 3 Overt testicular involvement (evidenced by ultrasonogram) but does not fulfill the criteria of stratum 3
OG002	Stratum 3

Secondary

Minimal Residual Disease (MRD)

Detectable disease in bone marrow or blood: A binary measure, positive (detectable), negative (non-detectable)

Seventeen participants had MRD data at day 8

Posted

Number

participants

Day 8

ID	Title	Description
OG000	Stratum 1	Minimal disseminated disease (MDD) <1% at diagnosis in T-lymphoblastic lymphoma No bone marrow involvement microscopically at diagnosis in B-lymphoblastic lymphoma Patients should not have: Any CNS involvement: CNS-3 status (i.e., ≥5 WBC/µL of CSF with blasts or cranial nerve palsy), CNS-2 status (<5 WBC/µL of CSF with blasts) or traumatic LP (>10 RBC/µL of CSF with blasts) Overt testicular involvement (evidenced by ultrasonogram).
OG001	Stratum 2	MDD ≥1% and MRD negative (<0.01%) on day 8 in T-lymphoblastic lymphoma Bone marrow involvement microscopically present at diagnosis in B-lymphoblastic lymphoma Any CNS involvement: CNS-3 status (i.e., ≥5 WBC/µL of CSF with blasts or cranial nerve palsy), CNS-2 status (<5 WBC/µL of CSF with blasts) or traumatic LP (>10 RBC/µL of CSF with blasts) but does not fulfill the criteria of stratum 3 Overt testicular involvement (evidenced by ultrasonogram) but does not fulfill the criteria of stratum 3
OG002	Stratum 3

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	Stratum 1	Minimal disseminated disease (MDD) <1% at diagnosis in T-lymphoblastic lymphoma No bone marrow involvement microscopically at diagnosis in B-lymphoblastic lymphoma Patients should not have: Any CNS involvement: CNS-3 status (i.e., ≥5 WBC/µL of CSF with blasts or cranial nerve palsy), CNS-2 status (<5 WBC/µL of CSF with blasts) or traumatic LP (>10 RBC/µL of CSF with blasts) Overt testicular involvement (evidenced by ultrasonogram).	2	12	0	12	12	12
EG001	Stratum 2	MDD ≥1% and MRD negative (<0.01%) on day 8 in T-lymphoblastic lymphoma Bone marrow involvement microscopically present at diagnosis in B-lymphoblastic lymphoma Any CNS involvement: CNS-3 status (i.e., ≥5 WBC/µL of CSF with blasts or cranial nerve palsy), CNS-2 status (<5 WBC/µL of CSF with blasts) or traumatic LP (>10 RBC/µL of CSF with blasts) but does not fulfill the criteria of stratum 3 Overt testicular involvement (evidenced by ultrasonogram) but does not fulfill the criteria of stratum 3	2	7	1	7	7	7
EG002	Stratum 3	Any patients with MDD ≥1% and MRD positive (≥0.01%) on day 8 in T-lymphoblastic lymphoma	0	4	0	4	4	4
EG003	All Enrollments	Twenty-three (23) eligible patients	4	23	1	23	23	23

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Febrile neutropenia	Blood and lymphatic system disorders	CTCAE Version 4.0	Systematic Assessment	EG00011 affected12 at risk EG0014 affected7 at risk EG0024 affected4 at risk EG00319 affected23 at risk
Upper respiratory infection	Infections and infestations	CTCAE Version 4.0	Systematic Assessment	EG00010 affected12 at risk EG0013 affected7 at risk EG0023 affected4 at risk EG003
Mucosal Infection	Infections and infestations	CTCAE Version 4.0	Systematic Assessment	EG0005 affected12 at risk EG0012 affected7 at risk EG0021 affected4 at risk EG003
Avascular necrosis	Musculoskeletal and connective tissue disorders	CTCAE Version 4.0	Systematic Assessment	EG0008 affected12 at risk EG0014 affected7 at risk EG0023 affected4 at risk EG003
Skin infection	Infections and infestations	CTCAE Version 4.0	Systematic Assessment	EG0006 affected12 at risk EG0013 affected7 at risk EG0021 affected4 at risk EG003
Alanine aminotransferase increased	Investigations	CTCAE Version 4.0	Systematic Assessment	EG0004 affected12 at risk EG0012 affected7 at risk EG0021 affected4 at risk EG003
Fever	General disorders	CTCAE Version 4.0	Systematic Assessment	EG0005 affected12 at risk EG0013 affected7 at risk EG0021 affected4 at risk EG003
Blood bilirubin increased	Investigations	CTCAE Version 4.0	Systematic Assessment	EG0004 affected12 at risk EG0011 affected7 at risk EG0021 affected4 at risk EG003
Hypoalbuminemia	Metabolism and nutrition disorders	CTCAE Version 4.0	Systematic Assessment	EG0003 affected12 at risk EG0013 affected7 at risk EG0022 affected4 at risk EG003
Sinusitis	Infections and infestations	CTCAE Version 4.0	Systematic Assessment	EG0005 affected12 at risk EG0012 affected7 at risk EG0021 affected4 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	CTCAE Version 4.0	Systematic Assessment	EG0005 affected12 at risk EG0010 affected7 at risk EG0022 affected4 at risk EG003
Otitis media	Infections and infestations	CTCAE Version 4.0	Systematic Assessment	EG0004 affected12 at risk EG0012 affected7 at risk EG0021 affected4 at risk EG003
Lipase increased	Investigations	CTCAE Version 4.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected7 at risk EG0021 affected4 at risk EG003
Vomiting	Gastrointestinal disorders	CTCAE Version 4.0	Systematic Assessment	EG0004 affected12 at risk EG0011 affected7 at risk EG0020 affected4 at risk EG003
Hypertriglyceridemia	Metabolism and nutrition disorders	CTCAE Version 4.0	Systematic Assessment	EG0003 affected12 at risk EG0012 affected7 at risk EG0021 affected4 at risk EG003
Depression	Psychiatric disorders	CTCAE Version 4.0	Systematic Assessment	EG0002 affected12 at risk EG0012 affected7 at risk EG0023 affected4 at risk EG003
Urinary tract infection	Infections and infestations	CTCAE Version 4.0	Systematic Assessment	EG0003 affected12 at risk EG0011 affected7 at risk EG0021 affected4 at risk EG003
Cholesterol high	Investigations	CTCAE Version 4.0	Systematic Assessment	EG0002 affected12 at risk EG0011 affected7 at risk EG0021 affected4 at risk EG003
Dehydration	Metabolism and nutrition disorders	CTCAE Version 4.0	Systematic Assessment	EG0003 affected12 at risk EG0013 affected7 at risk EG0020 affected4 at risk EG003
Neuralgia	Nervous system disorders	CTCAE Version 4.0	Systematic Assessment	EG0003 affected12 at risk EG0014 affected7 at risk EG0021 affected4 at risk EG003
Hypotension	Vascular disorders	CTCAE Version 4.0	Systematic Assessment	EG0003 affected12 at risk EG0010 affected7 at risk EG0021 affected4 at risk EG003
Abdominal pain	Gastrointestinal disorders	CTCAE Version 4.0	Systematic Assessment	EG0001 affected12 at risk EG0011 affected7 at risk EG0021 affected4 at risk EG003
Enterocolitis infectious	Infections and infestations	CTCAE Version 4.0	Systematic Assessment	EG0001 affected12 at risk EG0012 affected7 at risk EG0022 affected4 at risk EG003
Lung infection	Infections and infestations	CTCAE Version 4.0	Systematic Assessment	EG0003 affected12 at risk EG0011 affected7 at risk EG0021 affected4 at risk EG003
Aspartate aminotransferase increased	Investigations	CTCAE Version 4.0	Systematic Assessment	EG0003 affected12 at risk EG0010 affected7 at risk EG0020 affected4 at risk EG003
Hyponatremia	Metabolism and nutrition disorders	CTCAE Version 4.0	Systematic Assessment	EG0002 affected12 at risk EG0012 affected7 at risk EG0022 affected4 at risk EG003
Colitis	Gastrointestinal disorders	CTCAE Version 4.0	Systematic Assessment	EG0002 affected12 at risk EG0012 affected7 at risk EG0022 affected4 at risk EG003
Hyperglycemia	Metabolism and nutrition disorders	CTCAE Version 4.0	Systematic Assessment	EG0003 affected12 at risk EG0011 affected7 at risk EG0021 affected4 at risk EG003
Serum amylase increased	Investigations	CTCAE Version 4.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected7 at risk EG0020 affected4 at risk EG003
Hypokalemia	Metabolism and nutrition disorders	CTCAE Version 4.0	Systematic Assessment	EG0002 affected12 at risk EG0010 affected7 at risk EG0021 affected4 at risk EG003
Diarrhea	Gastrointestinal disorders	CTCAE Version 4.0	Systematic Assessment	EG0000 affected12 at risk EG0010 affected7 at risk EG0023 affected4 at risk EG003
Nausea	Gastrointestinal disorders	CTCAE Version 4.0	Systematic Assessment	EG0002 affected12 at risk EG0011 affected7 at risk EG0021 affected4 at risk EG003
Pancreatitis	Gastrointestinal disorders	CTCAE Version 4.0	Systematic Assessment	EG0002 affected12 at risk EG0010 affected7 at risk EG0021 affected4 at risk EG003
Abdominal infection	Infections and infestations	CTCAE Version 4.0	Systematic Assessment	EG0000 affected12 at risk EG0010 affected7 at risk EG0021 affected4 at risk EG003
Infections and infestations - Other, specify	Infections and infestations	CTCAE Version 4.0	Systematic Assessment	EG0001 affected12 at risk EG0012 affected7 at risk EG0020 affected4 at risk EG003
Paronychia	Infections and infestations	CTCAE Version 4.0	Systematic Assessment	EG0002 affected12 at risk EG0010 affected7 at risk EG0020 affected4 at risk EG003
Vaginal infection	Infections and infestations	CTCAE Version 4.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected7 at risk EG0020 affected4 at risk EG003
Anorexia	Metabolism and nutrition disorders	CTCAE Version 4.0	Systematic Assessment	EG0001 affected12 at risk EG0012 affected7 at risk EG0021 affected4 at risk EG003
Agitation	Psychiatric disorders	CTCAE Version 4.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected7 at risk EG0021 affected4 at risk EG003
Pain	General disorders	CTCAE Version 4.0	Systematic Assessment	EG0002 affected12 at risk EG0010 affected7 at risk EG0021 affected4 at risk EG003
Hepatobiliary disorders - Other, specify	Hepatobiliary disorders	CTCAE Version 4.0	Systematic Assessment	EG0002 affected12 at risk EG0010 affected7 at risk EG0021 affected4 at risk EG003
Wound infection	Infections and infestations	CTCAE Version 4.0	Systematic Assessment	EG0000 affected12 at risk EG0012 affected7 at risk EG0020 affected4 at risk EG003
Hypocalcemia	Metabolism and nutrition disorders	CTCAE Version 4.0	Systematic Assessment	EG0002 affected12 at risk EG0011 affected7 at risk EG0020 affected4 at risk EG003
Peripheral motor neuropathy	Nervous system disorders	CTCAE Version 4.0	Systematic Assessment	EG0002 affected12 at risk EG0010 affected7 at risk EG0021 affected4 at risk EG003
Syncope	Nervous system disorders	CTCAE Version 4.0	Systematic Assessment	EG0002 affected12 at risk EG0011 affected7 at risk EG0020 affected4 at risk EG003
Thromboembolic event	Vascular disorders	CTCAE Version 4.0	Systematic Assessment	EG0001 affected12 at risk EG0011 affected7 at risk EG0020 affected4 at risk EG003
Mucositis oral	Gastrointestinal disorders	CTCAE Version 4.0	Systematic Assessment	EG0000 affected12 at risk EG0012 affected7 at risk EG0020 affected4 at risk EG003
Rectal pain	Gastrointestinal disorders	CTCAE Version 4.0	Systematic Assessment	EG0001 affected12 at risk EG0011 affected7 at risk EG0020 affected4 at risk EG003
Allergic reaction	Immune system disorders	CTCAE Version 4.0	Systematic Assessment	EG0001 affected12 at risk EG0011 affected7 at risk EG0020 affected4 at risk EG003
Allergic reaction to Asparaginase	Immune system disorders	CTCAE Version 4.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected7 at risk EG0021 affected4 at risk EG003
Lip infection	Infections and infestations	CTCAE Version 4.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected7 at risk EG0021 affected4 at risk EG003
Pharyngitis	Infections and infestations	CTCAE Version 4.0	Systematic Assessment	EG0002 affected12 at risk EG0010 affected7 at risk EG0020 affected4 at risk EG003
Tooth infection	Infections and infestations	CTCAE Version 4.0	Systematic Assessment	EG0000 affected12 at risk EG0010 affected7 at risk EG0021 affected4 at risk EG003
Fall	Injury, poisoning and procedural complications	CTCAE Version 4.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected7 at risk EG0021 affected4 at risk EG003
Fracture	Injury, poisoning and procedural complications	CTCAE Version 4.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected7 at risk EG0021 affected4 at risk EG003
Injury, poisoning and procedural complications - Other, specify	Injury, poisoning and procedural complications	CTCAE Version 4.0	Systematic Assessment	EG0000 affected12 at risk EG0010 affected7 at risk EG0021 affected4 at risk EG003
Vascular access complication	Injury, poisoning and procedural complications	CTCAE Version 4.0	Systematic Assessment	EG0000 affected12 at risk EG0012 affected7 at risk EG0020 affected4 at risk EG003
GGT increased	Investigations	CTCAE Version 4.0	Systematic Assessment	EG0002 affected12 at risk EG0010 affected7 at risk EG0020 affected4 at risk EG003
Neutrophil count decreased	Investigations	CTCAE Version 4.0	Systematic Assessment	EG0000 affected12 at risk EG0010 affected7 at risk EG0021 affected4 at risk EG003
Hyperuricemia	Metabolism and nutrition disorders	CTCAE Version 4.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected7 at risk EG0021 affected4 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	CTCAE Version 4.0	Systematic Assessment	EG0002 affected12 at risk EG0010 affected7 at risk EG0020 affected4 at risk EG003
Cognitive disturbance	Nervous system disorders	CTCAE Version 4.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected7 at risk EG0021 affected4 at risk EG003
Seizure	Nervous system disorders	CTCAE Version 4.0	Systematic Assessment	EG0001 affected12 at risk EG0011 affected7 at risk EG0020 affected4 at risk EG003
Psychiatric disorders - Other, specify	Psychiatric disorders	CTCAE Version 4.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected7 at risk EG0020 affected4 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	CTCAE Version 4.0	Systematic Assessment	EG0002 affected12 at risk EG0010 affected7 at risk EG0020 affected4 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	CTCAE Version 4.0	Systematic Assessment	EG0000 affected12 at risk EG0010 affected7 at risk EG0021 affected4 at risk EG003
Hypertension	Vascular disorders	CTCAE Version 4.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected7 at risk EG0021 affected4 at risk EG003
Anemia	Blood and lymphatic system disorders	CTCAE Version 4.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected7 at risk EG0020 affected4 at risk EG003
Pericardial effusion	Cardiac disorders	CTCAE Version 4.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected7 at risk EG0020 affected4 at risk EG003
Endocrine disorders - Other, specify	Endocrine disorders	CTCAE Version 4.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected7 at risk EG0020 affected4 at risk EG003
Anal pain	Gastrointestinal disorders	CTCAE Version 4.0	Systematic Assessment	EG0000 affected12 at risk EG0010 affected7 at risk EG0021 affected4 at risk EG003
Enterocolitis	Gastrointestinal disorders	CTCAE Version 4.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected7 at risk EG0020 affected4 at risk EG003
Gastritis	Gastrointestinal disorders	CTCAE Version 4.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected7 at risk EG0020 affected4 at risk EG003
Oral pain	Gastrointestinal disorders	CTCAE Version 4.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected7 at risk EG0020 affected4 at risk EG003
Pancreatic necrosis	Gastrointestinal disorders	CTCAE Version 4.0	Systematic Assessment	EG0000 affected12 at risk EG0010 affected7 at risk EG0021 affected4 at risk EG003
Edema limbs	General disorders	CTCAE Version 4.0	Systematic Assessment	EG0000 affected12 at risk EG0010 affected7 at risk EG0021 affected4 at risk EG003
Malaise	General disorders	CTCAE Version 4.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected7 at risk EG0020 affected4 at risk EG003
Cholecystitis	Hepatobiliary disorders	CTCAE Version 4.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected7 at risk EG0020 affected4 at risk EG003
Hepatic failure	Hepatobiliary disorders	CTCAE Version 4.0	Systematic Assessment	EG0000 affected12 at risk EG0010 affected7 at risk EG0021 affected4 at risk EG003
Anaphylaxis	Immune system disorders	CTCAE Version 4.0	Systematic Assessment	EG0000 affected12 at risk EG0010 affected7 at risk EG0021 affected4 at risk EG003
Anorectal infection	Infections and infestations	CTCAE Version 4.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected7 at risk EG0020 affected4 at risk EG003
Sepsis	Infections and infestations	CTCAE Version 4.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected7 at risk EG0020 affected4 at risk EG003
Small intestine infection	Infections and infestations	CTCAE Version 4.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected7 at risk EG0020 affected4 at risk EG003
Soft tissue infection	Infections and infestations	CTCAE Version 4.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected7 at risk EG0020 affected4 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	CTCAE Version 4.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected7 at risk EG0020 affected4 at risk EG003
Spinal fracture	Injury, poisoning and procedural complications	CTCAE Version 4.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected7 at risk EG0020 affected4 at risk EG003
Weight loss	Investigations	CTCAE Version 4.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected7 at risk EG0020 affected4 at risk EG003
Glucose intolerance	Metabolism and nutrition disorders	CTCAE Version 4.0	Systematic Assessment	EG0000 affected12 at risk EG0010 affected7 at risk EG0021 affected4 at risk EG003
Hyperkalemia	Metabolism and nutrition disorders	CTCAE Version 4.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected7 at risk EG0020 affected4 at risk EG003
Hypernatremia	Metabolism and nutrition disorders	CTCAE Version 4.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected7 at risk EG0020 affected4 at risk EG003
Hypoglycemia	Metabolism and nutrition disorders	CTCAE Version 4.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected7 at risk EG0020 affected4 at risk EG003
Hypophosphatemia	Metabolism and nutrition disorders	CTCAE Version 4.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected7 at risk EG0020 affected4 at risk EG003
Tumor lysis syndrome	Metabolism and nutrition disorders	CTCAE Version 4.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected7 at risk EG0020 affected4 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	CTCAE Version 4.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected7 at risk EG0020 affected4 at risk EG003
Akathisia	Nervous system disorders	CTCAE Version 4.0	Systematic Assessment	EG0000 affected12 at risk EG0010 affected7 at risk EG0021 affected4 at risk EG003
Headache	Nervous system disorders	CTCAE Version 4.0	Systematic Assessment	EG0000 affected12 at risk EG0010 affected7 at risk EG0021 affected4 at risk EG003
Presyncope	Nervous system disorders	CTCAE Version 4.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected7 at risk EG0020 affected4 at risk EG003
Radiculitis	Nervous system disorders	CTCAE Version 4.0	Systematic Assessment	EG0000 affected12 at risk EG0010 affected7 at risk EG0021 affected4 at risk EG003
Anxiety	Psychiatric disorders	CTCAE Version 4.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected7 at risk EG0020 affected4 at risk EG003
Suicidal ideation	Psychiatric disorders	CTCAE Version 4.0	Systematic Assessment	EG0000 affected12 at risk EG0010 affected7 at risk EG0021 affected4 at risk EG003
Acute kidney injury	Renal and urinary disorders	CTCAE Version 4.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected7 at risk EG0020 affected4 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	CTCAE Version 4.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected7 at risk EG0020 affected4 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	CTCAE Version 4.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected7 at risk EG0020 affected4 at risk EG003
Pulmonary edema	Respiratory, thoracic and mediastinal disorders	CTCAE Version 4.0	Systematic Assessment	EG0000 affected12 at risk EG0010 affected7 at risk EG0021 affected4 at risk EG003
Pain of skin	Skin and subcutaneous tissue disorders	CTCAE Version 4.0	Systematic Assessment	EG0000 affected12 at risk EG0010 affected7 at risk EG0021 affected4 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	CTCAE Version 4.0	Systematic Assessment	EG0000 affected12 at risk EG0010 affected7 at risk EG0021 affected4 at risk EG003
Rash acneiform	Skin and subcutaneous tissue disorders	CTCAE Version 4.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected7 at risk EG0020 affected4 at risk EG003
Vascular disorders - Other, specify	Vascular disorders	CTCAE Version 4.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected7 at risk EG0020 affected4 at risk EG003

Ancestor Terms

ID	Term
D011244	Pregnadienediols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D011246	Pregnadienetriols
D014748	Vinca Alkaloids
D046948	Secologanin Tryptamine Alkaloids
D026121	Indole Alkaloids
D000470	Alkaloids
D006571	Heterocyclic Compounds
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D054836	Indolizidines
D007212	Indolizines
D018943	Anthracyclines
D009279	Naphthacenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D000617	Aminoglycosides
D006027	Glycosides
D002241	Carbohydrates
D000581	Amidohydrolases
D006867	Hydrolases
D004798	Enzymes
D045762	Enzymes and Coenzymes
D010752	Phosphoramide Mustards
D009588	Nitrogen Mustard Compounds
D009150	Mustard Compounds
D006846	Hydrocarbons, Halogenated
D063088	Phosphoramides
D009943	Organophosphorus Compounds
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D001087	Arabinonucleosides
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides
D011687	Purines
D000227	Adenine Nucleotides
D011685	Purine Nucleotides
D009711	Nucleotides
D012265	Ribonucleotides
D000630	Aminopterin
D011622	Pterins
D011621	Pteridines
D013438	Sulfhydryl Compounds
D013457	Sulfur Compounds
D013259	Steroids, Fluorinated
D001557	Benzenesulfonates
D001555	Benzene Derivatives
D001190	Arylsulfonates
D017739	Arylsulfonic Acids
D013451	Sulfonic Acids
D013456	Sulfur Acids
D011282	Pregnenediones
D011283	Pregnenes
D015062	11-Hydroxycorticosteroids
D006889	Hydroxycorticosteroids
D000305	Adrenal Cortex Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D015065	17-Hydroxycorticosteroids
D011034	Podophyllotoxin
D013764	Tetrahydronaphthalenes
D009281	Naphthalenes
D005960	Glucosides

ID	Term
D007945	Leukemia, Lymphoid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases

ID	Term
D011241	Prednisone
D011239	Prednisolone
D014750	Vincristine
D003630	Daunorubicin
C042705	pegaspargase
C000718243	asparaginase erwinia chrysanthemi recombinant
D001215	Asparaginase
D004317	Doxorubicin
D003520	Cyclophosphamide
D003561	Cytarabine
D013866	Thioguanine
D000077866	Clofarabine
D008727	Methotrexate
D015122	Mercaptopurine
D003907	Dexamethasone
D002123	Calcium Dobesilate
D006854	Hydrocortisone
D005047	Etoposide