ID

41080

Beschreibung

Hyper-CVAD and Ponatinib in Ph-Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia (ALL); ODM derived from: https://clinicaltrials.gov/show/NCT01424982

Link

https://clinicaltrials.gov/show/NCT01424982

Stichworte

Versionen (1)
  1. 20.06.20 20.06.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

20. Juni 2020

DOI

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Lizenz

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Eligibility Leukemia NCT01424982

Englisch

Eligibility Leukemia NCT01424982

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01424982
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. diagnosis of one of the following: a) previously untreated ph-positive all [either t(9;22) and/or bcr-abl positive] (includes patients initiated on first course of hyper-cvad before cytogenetics known); b) previously treated ph-positive all, after 1-2 courses of chemotherapy with or without other tkis 1) if they achieved cr, they are assessable only for event-free and overall survival, or 2) if they failed to achieve cr, they are assessable for cr, event-free, and overall survival.
Beschreibung

Philadelphia positive ALL Untreated | t(9;22) | BCR-ABL Positive | HyperCVAD Regimen | Prior Therapy Philadelphia positive ALL | Status post Chemotherapy Quantity | Protein-tyrosine kinase inhibitor | Protein-tyrosine kinase inhibitor Absent | In complete remission | Complete remission failed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4524071
UMLS CUI [1,2]
C0332155
UMLS CUI [2]
C3897138
UMLS CUI [3,1]
C1835417
UMLS CUI [3,2]
C1514241
UMLS CUI [4]
C1881082
UMLS CUI [5,1]
C1514463
UMLS CUI [5,2]
C4524071
UMLS CUI [6,1]
C0231290
UMLS CUI [6,2]
C0392920
UMLS CUI [6,3]
C1265611
UMLS CUI [7]
C1268567
UMLS CUI [8,1]
C1268567
UMLS CUI [8,2]
C0332197
UMLS CUI [9]
C0677874
UMLS CUI [10,1]
C0677874
UMLS CUI [10,2]
C0231175
2. age >/= 18 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
3. performance status </= 2 (ecog scale, appendix e)
Beschreibung

Performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1518965
4. adequate liver function as defined by the following criteria: a) total serum bilirubin </= 1.5 x upper limit of normal (uln), unless due to gilbert's syndrome, b) alanine aminotransferase (alt) </= 2 x uln, c) aspartate aminotransferase (ast) </= 2.5 x uln)
Beschreibung

Liver function | Serum total bilirubin measurement | Exception Due to Gilbert Disease | Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0017551
UMLS CUI [4]
C0201836
UMLS CUI [5]
C0201899
5. adequate pancreatic function as defined by the following criteria: a) serum lipase and amylase </= 1.5 x uln),
Beschreibung

Pancreatic function | Serum lipase measurement | Amylase measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0232786
UMLS CUI [2]
C0428316
UMLS CUI [3]
C0201885
6. for females of childbearing potential, a negative pregnancy test must be documented prior to randomization
Beschreibung

Childbearing Potential Pregnancy test negative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
7. female and male patients who are fertile must agree to use an effective form of contraception with their sexual partners from randomization through 4 months after the end of treatment
Beschreibung

Females & males of reproductive potential Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
8. adequate cardiac function as assessed clinically by history and physical examination.
Beschreibung

Cardiac function Medical History | Cardiac function Physical Examination

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0232164
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C0232164
UMLS CUI [2,2]
C0031809
9. signed informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. active serious infection not controlled by oral or intravenous antibiotics
Beschreibung

Communicable Disease Serious Uncontrolled | Antibiotics Oral Absent | Antibiotics Intravenous Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0205318
UMLS CUI [2,1]
C0003232
UMLS CUI [2,2]
C1527415
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C0003232
UMLS CUI [3,2]
C1522726
UMLS CUI [3,3]
C0332197
2. history of acute pancreatitis within 1 year of study or history of chronic pancreatitis
Beschreibung

Pancreatitis | Pancreatitis, Chronic

Datentyp

boolean

Alias
UMLS CUI [1]
C0030305
UMLS CUI [2]
C0149521
3. history of alcohol abuse
Beschreibung

Alcohol abuse

Datentyp

boolean

Alias
UMLS CUI [1]
C0085762
4. uncontrolled hypertriglyceridemia (triglycerides > 450mg/dl)
Beschreibung

Hypertriglyceridemia Uncontrolled | Triglycerides measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020557
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0202236
5. active secondary malignancy other than skin cancer (e.g., basal cell carcinoma or squamous cell carcinoma) that in the investigator's opinion will shorten survival to less than 1 year
Beschreibung

Secondary Malignant Neoplasm Reducing Life Expectancy | Exception Skin carcinoma | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3266877
UMLS CUI [1,2]
C0392756
UMLS CUI [1,3]
C0023671
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0553723
6. active grade iii-v cardiac failure as defined by the new york heart association criteria
Beschreibung

Heart failure New York Heart Association Classification

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
7. clinically significant, uncontrolled, or active cardiovascular disease, specifically including, but not restricted to: any history of myocardial infarction (mi), stroke, or revascularization; unstable angina or transient ischemic attack prior to enrollment; congestive heart failure prior to enrollment, or left ventricular ejection fraction (lvef) less than lower limit of normal per local institutional standards prior to enrollment; diagnosed or suspected congenital long qt syndrome; any history of clinically significant atrial or ventricular arrhythmias (such as atrial fibrillation, ventricular tachycardia, ventricular fibrillation, or torsades de pointes) as determined by the treating physician; prolonged qtc interval on pre-entry electrocardiogram (> 470 msec) unless corrected after electrolyte replacement; any history of venous thromboembolism including deep venous thrombosis or pulmonary embolism;
Beschreibung

Cardiovascular Disease Uncontrolled | Cardiovascular Disease | Myocardial Infarction | Cerebrovascular accident | Revascularization | Angina, Unstable | Transient Ischemic Attack | Congestive heart failure | Left ventricular ejection fraction decreased | Congenital long QT syndrome | Congenital long QT syndrome Suspected | Atrial arrhythmia | Ventricular arrhythmia | Atrial Fibrillation | Tachycardia, Ventricular | Ventricular Fibrillation | Torsades de Pointes | Prolonged QTc interval Electrocardiography | Exception Electrolyte replacement | Venous Thromboembolism | Deep Vein Thrombosis | Pulmonary Embolism

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0007222
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0038454
UMLS CUI [5]
C0581603
UMLS CUI [6]
C0002965
UMLS CUI [7]
C0007787
UMLS CUI [8]
C0018802
UMLS CUI [9]
C1096403
UMLS CUI [10]
C1141890
UMLS CUI [11,1]
C1141890
UMLS CUI [11,2]
C0750491
UMLS CUI [12]
C0085611
UMLS CUI [13]
C0085612
UMLS CUI [14]
C0004238
UMLS CUI [15]
C0042514
UMLS CUI [16]
C0042510
UMLS CUI [17]
C0040479
UMLS CUI [18,1]
C1560305
UMLS CUI [18,2]
C1623258
UMLS CUI [19,1]
C1705847
UMLS CUI [19,2]
C0854632
UMLS CUI [20]
C1861172
UMLS CUI [21]
C0149871
UMLS CUI [22]
C0034065
8. continued from #7: uncontrolled hypertension (diastolic blood pressure >90mmhg; systolic >140mmhg). patients with hypertension should be under treatment on study entry to effect blood pressure control.
Beschreibung

Uncontrolled hypertension | Diastolic blood pressure | Systolic Pressure | On treatment for hypertension

Datentyp

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0428883
UMLS CUI [3]
C0871470
UMLS CUI [4]
C0578998
9. patients currently taking drugs that are generally accepted to have a risk of causing torsades de pointes (unless these can be changed to acceptable alternatives)
Beschreibung

Pharmaceutical Preparations At risk Torsades de Pointes

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0040479
10. taking any medications or herbal supplements that are known to be strong inhibitors of cyp3a4 within at least 14 days before the first dose of ponatinib
Beschreibung

CYP3A4 Inhibitors Strong

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3850053
UMLS CUI [1,2]
C0442821
11. prior history of treatment with ponatinib
Beschreibung

ponatinib

Datentyp

boolean

Alias
UMLS CUI [1]
C2987417
12. treatment with any investigational antileukemic agents or chemotherapy agents in the last 7 days before study entry, unless full recovery from side effects has occurred or patient has rapidly progressive disease judged to be life-threatening by the investigator
Beschreibung

Antileukemic Agent Investigational | Antineoplastic Agents Investigational

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0596112
UMLS CUI [1,2]
C1517586
UMLS CUI [2,1]
C0003392
UMLS CUI [2,2]
C1517586
13. pregnant and lactating women will not be eligible; women of childbearing potential should have a negative pregnancy test prior to entering on the study and be willing to practice methods of contraception. women do not have childbearing potential if they have had a hysterectomy or are postmenopausal without menses for 12 months. in addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control
Beschreibung

Pregnancy | Breast Feeding | Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods | Gender Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0427780
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
UMLS CUI [5,1]
C0079399
UMLS CUI [5,2]
C0700589
14. history of significant bleeding disorder unrelated to cancer, including: a) diagnosed congenital bleeding disorders (e.g., von willebrand's disease), b) diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor viii antibodies)
Beschreibung

Blood Coagulation Disorder Independent of Malignant Neoplasm | Congenital Bleeding Disorder | von Willebrand Disease | Blood Coagulation Disorder Acquired | Anti-factor VIII antibodies Acquired

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005779
UMLS CUI [1,2]
C0332291
UMLS CUI [1,3]
C0006826
UMLS CUI [2]
C3641106
UMLS CUI [3]
C0042974
UMLS CUI [4,1]
C0005779
UMLS CUI [4,2]
C0439661
UMLS CUI [5,1]
C0877535
UMLS CUI [5,2]
C0439661
15. patients with documented significant pleural or pericardial effusions unless they are thought to be secondary to their leukemia
Beschreibung

Pleural effusion | Pericardial effusion | Exception Secondary to Leukemia

Datentyp

boolean

Alias
UMLS CUI [1]
C0032227
UMLS CUI [2]
C0031039
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0175668
UMLS CUI [3,3]
C0023418
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Ähnliche Modelle

Eligibility Leukemia NCT01424982

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01424982
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Philadelphia positive ALL Untreated | t(9;22) | BCR-ABL Positive | HyperCVAD Regimen | Prior Therapy Philadelphia positive ALL | Status post Chemotherapy Quantity | Protein-tyrosine kinase inhibitor | Protein-tyrosine kinase inhibitor Absent | In complete remission | Complete remission failed
Item
1. diagnosis of one of the following: a) previously untreated ph-positive all [either t(9;22) and/or bcr-abl positive] (includes patients initiated on first course of hyper-cvad before cytogenetics known); b) previously treated ph-positive all, after 1-2 courses of chemotherapy with or without other tkis 1) if they achieved cr, they are assessable only for event-free and overall survival, or 2) if they failed to achieve cr, they are assessable for cr, event-free, and overall survival.
boolean
C4524071 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C3897138 (UMLS CUI [2])
C1835417 (UMLS CUI [3,1])
C1514241 (UMLS CUI [3,2])
C1881082 (UMLS CUI [4])
C1514463 (UMLS CUI [5,1])
C4524071 (UMLS CUI [5,2])
C0231290 (UMLS CUI [6,1])
C0392920 (UMLS CUI [6,2])
C1265611 (UMLS CUI [6,3])
C1268567 (UMLS CUI [7])
C1268567 (UMLS CUI [8,1])
C0332197 (UMLS CUI [8,2])
C0677874 (UMLS CUI [9])
C0677874 (UMLS CUI [10,1])
C0231175 (UMLS CUI [10,2])
Age
Item
2. age >/= 18 years
boolean
C0001779 (UMLS CUI [1])
Performance status
Item
3. performance status </= 2 (ecog scale, appendix e)
boolean
C1518965 (UMLS CUI [1])
Liver function | Serum total bilirubin measurement | Exception Due to Gilbert Disease | Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
4. adequate liver function as defined by the following criteria: a) total serum bilirubin </= 1.5 x upper limit of normal (uln), unless due to gilbert's syndrome, b) alanine aminotransferase (alt) </= 2 x uln, c) aspartate aminotransferase (ast) </= 2.5 x uln)
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0017551 (UMLS CUI [3,3])
C0201836 (UMLS CUI [4])
C0201899 (UMLS CUI [5])
Pancreatic function | Serum lipase measurement | Amylase measurement, serum
Item
5. adequate pancreatic function as defined by the following criteria: a) serum lipase and amylase </= 1.5 x uln),
boolean
C0232786 (UMLS CUI [1])
C0428316 (UMLS CUI [2])
C0201885 (UMLS CUI [3])
Childbearing Potential Pregnancy test negative
Item
6. for females of childbearing potential, a negative pregnancy test must be documented prior to randomization
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Females & males of reproductive potential Contraceptive methods
Item
7. female and male patients who are fertile must agree to use an effective form of contraception with their sexual partners from randomization through 4 months after the end of treatment
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Cardiac function Medical History | Cardiac function Physical Examination
Item
8. adequate cardiac function as assessed clinically by history and physical examination.
boolean
C0232164 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0232164 (UMLS CUI [2,1])
C0031809 (UMLS CUI [2,2])
Informed Consent
Item
9. signed informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Communicable Disease Serious Uncontrolled | Antibiotics Oral Absent | Antibiotics Intravenous Absent
Item
1. active serious infection not controlled by oral or intravenous antibiotics
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C0003232 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0003232 (UMLS CUI [3,1])
C1522726 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Pancreatitis | Pancreatitis, Chronic
Item
2. history of acute pancreatitis within 1 year of study or history of chronic pancreatitis
boolean
C0030305 (UMLS CUI [1])
C0149521 (UMLS CUI [2])
Alcohol abuse
Item
3. history of alcohol abuse
boolean
C0085762 (UMLS CUI [1])
Hypertriglyceridemia Uncontrolled | Triglycerides measurement
Item
4. uncontrolled hypertriglyceridemia (triglycerides > 450mg/dl)
boolean
C0020557 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0202236 (UMLS CUI [2])
Secondary Malignant Neoplasm Reducing Life Expectancy | Exception Skin carcinoma | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin
Item
5. active secondary malignancy other than skin cancer (e.g., basal cell carcinoma or squamous cell carcinoma) that in the investigator's opinion will shorten survival to less than 1 year
boolean
C3266877 (UMLS CUI [1,1])
C0392756 (UMLS CUI [1,2])
C0023671 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
Heart failure New York Heart Association Classification
Item
6. active grade iii-v cardiac failure as defined by the new york heart association criteria
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Cardiovascular Disease Uncontrolled | Cardiovascular Disease | Myocardial Infarction | Cerebrovascular accident | Revascularization | Angina, Unstable | Transient Ischemic Attack | Congestive heart failure | Left ventricular ejection fraction decreased | Congenital long QT syndrome | Congenital long QT syndrome Suspected | Atrial arrhythmia | Ventricular arrhythmia | Atrial Fibrillation | Tachycardia, Ventricular | Ventricular Fibrillation | Torsades de Pointes | Prolonged QTc interval Electrocardiography | Exception Electrolyte replacement | Venous Thromboembolism | Deep Vein Thrombosis | Pulmonary Embolism
Item
7. clinically significant, uncontrolled, or active cardiovascular disease, specifically including, but not restricted to: any history of myocardial infarction (mi), stroke, or revascularization; unstable angina or transient ischemic attack prior to enrollment; congestive heart failure prior to enrollment, or left ventricular ejection fraction (lvef) less than lower limit of normal per local institutional standards prior to enrollment; diagnosed or suspected congenital long qt syndrome; any history of clinically significant atrial or ventricular arrhythmias (such as atrial fibrillation, ventricular tachycardia, ventricular fibrillation, or torsades de pointes) as determined by the treating physician; prolonged qtc interval on pre-entry electrocardiogram (> 470 msec) unless corrected after electrolyte replacement; any history of venous thromboembolism including deep venous thrombosis or pulmonary embolism;
boolean
C0007222 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0038454 (UMLS CUI [4])
C0581603 (UMLS CUI [5])
C0002965 (UMLS CUI [6])
C0007787 (UMLS CUI [7])
C0018802 (UMLS CUI [8])
C1096403 (UMLS CUI [9])
C1141890 (UMLS CUI [10])
C1141890 (UMLS CUI [11,1])
C0750491 (UMLS CUI [11,2])
C0085611 (UMLS CUI [12])
C0085612 (UMLS CUI [13])
C0004238 (UMLS CUI [14])
C0042514 (UMLS CUI [15])
C0042510 (UMLS CUI [16])
C0040479 (UMLS CUI [17])
C1560305 (UMLS CUI [18,1])
C1623258 (UMLS CUI [18,2])
C1705847 (UMLS CUI [19,1])
C0854632 (UMLS CUI [19,2])
C1861172 (UMLS CUI [20])
C0149871 (UMLS CUI [21])
C0034065 (UMLS CUI [22])
Uncontrolled hypertension | Diastolic blood pressure | Systolic Pressure | On treatment for hypertension
Item
8. continued from #7: uncontrolled hypertension (diastolic blood pressure >90mmhg; systolic >140mmhg). patients with hypertension should be under treatment on study entry to effect blood pressure control.
boolean
C1868885 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
C0871470 (UMLS CUI [3])
C0578998 (UMLS CUI [4])
Pharmaceutical Preparations At risk Torsades de Pointes
Item
9. patients currently taking drugs that are generally accepted to have a risk of causing torsades de pointes (unless these can be changed to acceptable alternatives)
boolean
C0013227 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0040479 (UMLS CUI [1,3])
CYP3A4 Inhibitors Strong
Item
10. taking any medications or herbal supplements that are known to be strong inhibitors of cyp3a4 within at least 14 days before the first dose of ponatinib
boolean
C3850053 (UMLS CUI [1,1])
C0442821 (UMLS CUI [1,2])
ponatinib
Item
11. prior history of treatment with ponatinib
boolean
C2987417 (UMLS CUI [1])
Antileukemic Agent Investigational | Antineoplastic Agents Investigational
Item
12. treatment with any investigational antileukemic agents or chemotherapy agents in the last 7 days before study entry, unless full recovery from side effects has occurred or patient has rapidly progressive disease judged to be life-threatening by the investigator
boolean
C0596112 (UMLS CUI [1,1])
C1517586 (UMLS CUI [1,2])
C0003392 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
Pregnancy | Breast Feeding | Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods | Gender Contraceptive methods
Item
13. pregnant and lactating women will not be eligible; women of childbearing potential should have a negative pregnancy test prior to entering on the study and be willing to practice methods of contraception. women do not have childbearing potential if they have had a hysterectomy or are postmenopausal without menses for 12 months. in addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0427780 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0079399 (UMLS CUI [5,1])
C0700589 (UMLS CUI [5,2])
Blood Coagulation Disorder Independent of Malignant Neoplasm | Congenital Bleeding Disorder | von Willebrand Disease | Blood Coagulation Disorder Acquired | Anti-factor VIII antibodies Acquired
Item
14. history of significant bleeding disorder unrelated to cancer, including: a) diagnosed congenital bleeding disorders (e.g., von willebrand's disease), b) diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor viii antibodies)
boolean
C0005779 (UMLS CUI [1,1])
C0332291 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
C3641106 (UMLS CUI [2])
C0042974 (UMLS CUI [3])
C0005779 (UMLS CUI [4,1])
C0439661 (UMLS CUI [4,2])
C0877535 (UMLS CUI [5,1])
C0439661 (UMLS CUI [5,2])
Pleural effusion | Pericardial effusion | Exception Secondary to Leukemia
Item
15. patients with documented significant pleural or pericardial effusions unless they are thought to be secondary to their leukemia
boolean
C0032227 (UMLS CUI [1])
C0031039 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0175668 (UMLS CUI [3,2])
C0023418 (UMLS CUI [3,3])
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