ID

15406

Description

Safety and Efficacy Study of Apixaban to Prevent Clots in Children With Leukemia Who Have a Central Venous Catheter and Are Treated With PEG Asparaginase; ODM derived from: https://clinicaltrials.gov/show/NCT02369653

Link

https://clinicaltrials.gov/show/NCT02369653

Keywords

Versions (1)
  1. 5/30/16 5/30/16 -
Uploaded on

May 30, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Lymphoma NCT02369653

English

Eligibility Lymphoma NCT02369653

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT02369653
Criteria
Description

Criteria

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
new diagnosis of de novo all or lymphomas (t or b cell)
Description

Acute lymphocytic leukemia de novo | T-Cell Lymphoma de novo | B-Cell Lymphoma de novo

Data type

boolean

Alias
UMLS CUI [1,1]
C0023449
UMLS CUI [1,2]
C1515568
UMLS CUI [2,1]
C0079772
UMLS CUI [2,2]
C1515568
UMLS CUI [3,1]
C0079731
UMLS CUI [3,2]
C1515568
planned induction chemotherapy with a corticosteroid, vincristine and peg l-asparaginase, with or without daunorubicin consistent with the children's oncology group (cog) all trials
Description

Induction Chemotherapy Planned | Adrenal Cortex Hormones | Vincristine | pegaspargase | Daunorubicin | Children's Oncology Group | Acute lymphocytic leukemia

Data type

boolean

Alias
UMLS CUI [1,1]
C3179010
UMLS CUI [1,2]
C1301732
UMLS CUI [2]
C0001617
UMLS CUI [3]
C0042679
UMLS CUI [4]
C0071568
UMLS CUI [5]
C0011015
UMLS CUI [6]
C1516477
UMLS CUI [7]
C0023449
functioning central venous access device
Description

Central venous catheter, device functioning

Data type

boolean

Alias
UMLS CUI [1,1]
C1145640
UMLS CUI [1,2]
C0542341
must be able to tolerate oral medication or have it administered via an nasogastric tube (ngt) or gt tube
Description

oral medication Able to swallow | Administration Nasogastric tube | Administration Gastric Tube

Data type

boolean

Alias
UMLS CUI [1,1]
C0175795
UMLS CUI [1,2]
C2712086
UMLS CUI [2,1]
C0013153
UMLS CUI [2,2]
C0085678
UMLS CUI [3,1]
C0013153
UMLS CUI [3,2]
C1546658
males and females,age 1 year(365 days) to < 18 (17 years and 364 days) years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
platelet counts ≥ 20000/microl
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
central nervous system (cns) 3 status leukemia
Description

leukemia CNS3

Data type

boolean

Alias
UMLS CUI [1,1]
C0023418
UMLS CUI [1,2]
C3899748
prior history of documented dvt or pe in the past 3 months
Description

Deep Vein Thrombosis | Pulmonary Embolism

Data type

boolean

Alias
UMLS CUI [1]
C0149871
UMLS CUI [2]
C0034065
known inherited bleeding disorder or coagulopathy
Description

Blood Coagulation Disorder Hereditary | hereditary coagulopathy

Data type

boolean

Alias
UMLS CUI [1,1]
C0005779
UMLS CUI [1,2]
C0439660
UMLS CUI [2]
C0679428
major surgery (excluding cvad placement and bone marrow aspiration and biopsy) within the last 30 days that may be associated with a risk of bleeding
Description

major surgery | Insertion of Central Venous Access Device | Bone marrow aspiration procedure | Biopsy | Hemorrhage Risk

Data type

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C1610121
UMLS CUI [3]
C0398523
UMLS CUI [4]
C0005558
UMLS CUI [5,1]
C0019080
UMLS CUI [5,2]
C0035647
uncontrolled severe hypertension at enrollment. severe hypertension is defined as a systolic or diastolic blood pressure (bp) > 5 mm hg above the 95th percentile as defined by the national high blood pressure education program working group (nhbpep) established guidelines for the definition of normal and elevated blood pressure in children
Description

Hypertension, severe Uncontrolled | Systolic Pressure | Diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1,1]
C4013784
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
extreme hyperleukocytosis, white blood cell (wbc) counts over 200 x 109/l (200,000/microl) at the time of diagnosis
Description

Hyperleukocytic syndrome Extreme | White Blood Cell Count procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C3805210
UMLS CUI [1,2]
C0205403
UMLS CUI [2]
C0023508
liver dysfunction manifested by sgtp (alt) > 5x upper limit of normal (uln) and/or aspartate aminotransferase (ast) >5 x uln and/or direct (conjugated) bilirubin > 2x uln
Description

Liver Dysfunction | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Bilirubin, direct measurement

Data type

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201916
renal function < 30% of normal for age and size as determined by the schwartz formula
Description

Renal function | Age | Body Height | Creatinine-based formula (Schwartz)

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0005890
UMLS CUI [4]
C1980037
prothrombin time(pt)> 1 second above the upper limit of normal for age,partial thromboplastin time (ptt) > 3 seconds above the upper limit of normal for age and international normalized ratio(inr) above the upper limit of normal for age, within 1 week prior to enrollment.
Description

Prothrombin time test | Partial thromboplastin time finding | Age | International Normalized Ratio

Data type

boolean

Alias
UMLS CUI [1]
C0491338
UMLS CUI [2]
C1531697
UMLS CUI [3]
C0001779
UMLS CUI [4]
C0525032
history of allergy to apixaban or factor xa inhibitors
Description

Hypersensitivity apixaban | Hypersensitivity Factor Xa Inhibitors

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1831808
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C2267054
history of significant adverse reaction or major bleeding related adverse reaction to other anticoagulant or antiplatelet agents
Description

IAdverse reaction Due to Hemorrhage Major | Adverse reaction Anticoagulants | Adverse reaction Antiplatelet Agents

Data type

boolean

Alias
UMLS CUI [1,1]
C0559546
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0019080
UMLS CUI [1,4]
C0205164
UMLS CUI [2,1]
C0559546
UMLS CUI [2,2]
C0003280
UMLS CUI [3,1]
C0559546
UMLS CUI [3,2]
C0085826
history of any significant drug allergy (such as anaphylaxis or hepatotoxicity
Description

Drug Allergy | anaphylaxis | Hepatotoxicity

Data type

boolean

Alias
UMLS CUI [1]
C0013182
UMLS CUI [2]
C0002792
UMLS CUI [3]
C0235378
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Similar models

Eligibility Lymphoma NCT02369653

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT02369653
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Item Group
C1512693 (UMLS CUI)
Acute lymphocytic leukemia de novo | T-Cell Lymphoma de novo | B-Cell Lymphoma de novo
Item
new diagnosis of de novo all or lymphomas (t or b cell)
boolean
C0023449 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
C0079772 (UMLS CUI [2,1])
C1515568 (UMLS CUI [2,2])
C0079731 (UMLS CUI [3,1])
C1515568 (UMLS CUI [3,2])
Induction Chemotherapy Planned | Adrenal Cortex Hormones | Vincristine | pegaspargase | Daunorubicin | Children's Oncology Group | Acute lymphocytic leukemia
Item
planned induction chemotherapy with a corticosteroid, vincristine and peg l-asparaginase, with or without daunorubicin consistent with the children's oncology group (cog) all trials
boolean
C3179010 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0001617 (UMLS CUI [2])
C0042679 (UMLS CUI [3])
C0071568 (UMLS CUI [4])
C0011015 (UMLS CUI [5])
C1516477 (UMLS CUI [6])
C0023449 (UMLS CUI [7])
Central venous catheter, device functioning
Item
functioning central venous access device
boolean
C1145640 (UMLS CUI [1,1])
C0542341 (UMLS CUI [1,2])
oral medication Able to swallow | Administration Nasogastric tube | Administration Gastric Tube
Item
must be able to tolerate oral medication or have it administered via an nasogastric tube (ngt) or gt tube
boolean
C0175795 (UMLS CUI [1,1])
C2712086 (UMLS CUI [1,2])
C0013153 (UMLS CUI [2,1])
C0085678 (UMLS CUI [2,2])
C0013153 (UMLS CUI [3,1])
C1546658 (UMLS CUI [3,2])
Age
Item
males and females,age 1 year(365 days) to < 18 (17 years and 364 days) years.
boolean
C0001779 (UMLS CUI [1])
Platelet Count measurement
Item
platelet counts ≥ 20000/microl
boolean
C0032181 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
leukemia CNS3
Item
central nervous system (cns) 3 status leukemia
boolean
C0023418 (UMLS CUI [1,1])
C3899748 (UMLS CUI [1,2])
Deep Vein Thrombosis | Pulmonary Embolism
Item
prior history of documented dvt or pe in the past 3 months
boolean
C0149871 (UMLS CUI [1])
C0034065 (UMLS CUI [2])
Blood Coagulation Disorder Hereditary | hereditary coagulopathy
Item
known inherited bleeding disorder or coagulopathy
boolean
C0005779 (UMLS CUI [1,1])
C0439660 (UMLS CUI [1,2])
C0679428 (UMLS CUI [2])
major surgery | Insertion of Central Venous Access Device | Bone marrow aspiration procedure | Biopsy | Hemorrhage Risk
Item
major surgery (excluding cvad placement and bone marrow aspiration and biopsy) within the last 30 days that may be associated with a risk of bleeding
boolean
C0679637 (UMLS CUI [1])
C1610121 (UMLS CUI [2])
C0398523 (UMLS CUI [3])
C0005558 (UMLS CUI [4])
C0019080 (UMLS CUI [5,1])
C0035647 (UMLS CUI [5,2])
Hypertension, severe Uncontrolled | Systolic Pressure | Diastolic blood pressure
Item
uncontrolled severe hypertension at enrollment. severe hypertension is defined as a systolic or diastolic blood pressure (bp) > 5 mm hg above the 95th percentile as defined by the national high blood pressure education program working group (nhbpep) established guidelines for the definition of normal and elevated blood pressure in children
boolean
C4013784 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Hyperleukocytic syndrome Extreme | White Blood Cell Count procedure
Item
extreme hyperleukocytosis, white blood cell (wbc) counts over 200 x 109/l (200,000/microl) at the time of diagnosis
boolean
C3805210 (UMLS CUI [1,1])
C0205403 (UMLS CUI [1,2])
C0023508 (UMLS CUI [2])
Liver Dysfunction | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Bilirubin, direct measurement
Item
liver dysfunction manifested by sgtp (alt) > 5x upper limit of normal (uln) and/or aspartate aminotransferase (ast) >5 x uln and/or direct (conjugated) bilirubin > 2x uln
boolean
C0086565 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201916 (UMLS CUI [4])
Renal function | Age | Body Height | Creatinine-based formula (Schwartz)
Item
renal function < 30% of normal for age and size as determined by the schwartz formula
boolean
C0232804 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0005890 (UMLS CUI [3])
C1980037 (UMLS CUI [4])
Prothrombin time test | Partial thromboplastin time finding | Age | International Normalized Ratio
Item
prothrombin time(pt)> 1 second above the upper limit of normal for age,partial thromboplastin time (ptt) > 3 seconds above the upper limit of normal for age and international normalized ratio(inr) above the upper limit of normal for age, within 1 week prior to enrollment.
boolean
C0491338 (UMLS CUI [1])
C1531697 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C0525032 (UMLS CUI [4])
Hypersensitivity apixaban | Hypersensitivity Factor Xa Inhibitors
Item
history of allergy to apixaban or factor xa inhibitors
boolean
C0020517 (UMLS CUI [1,1])
C1831808 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C2267054 (UMLS CUI [2,2])
IAdverse reaction Due to Hemorrhage Major | Adverse reaction Anticoagulants | Adverse reaction Antiplatelet Agents
Item
history of significant adverse reaction or major bleeding related adverse reaction to other anticoagulant or antiplatelet agents
boolean
C0559546 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0019080 (UMLS CUI [1,3])
C0205164 (UMLS CUI [1,4])
C0559546 (UMLS CUI [2,1])
C0003280 (UMLS CUI [2,2])
C0559546 (UMLS CUI [3,1])
C0085826 (UMLS CUI [3,2])
Drug Allergy | anaphylaxis | Hepatotoxicity
Item
history of any significant drug allergy (such as anaphylaxis or hepatotoxicity
boolean
C0013182 (UMLS CUI [1])
C0002792 (UMLS CUI [2])
C0235378 (UMLS CUI [3])
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