ID

39808

Description

Transcatheter Arterial Chemoembolization Combined With Sorafenib for Unresectable Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01833299

Lien

https://clinicaltrials.gov/show/NCT01833299

Mots-clés

Versions (2)
  1. 21/02/2020 21/02/2020 -
  2. 27/09/2021 27/09/2021 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

21 février 2020

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT01833299

Anglais

Eligibility Hepatocellular Carcinoma NCT01833299

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. adults patients ( 18-75 years of age) with a diagnosis of hcc which is not amenable to surgical resection or local ablative therapy
Description

Adult | Age | Liver carcinoma Inappropriate Excision | Liver carcinoma Inappropriate Local Ablation Therapy

Type de données

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C2239176
UMLS CUI [3,2]
C1548788
UMLS CUI [3,3]
C0728940
UMLS CUI [4,1]
C2239176
UMLS CUI [4,2]
C1548788
UMLS CUI [4,3]
C0547070
2. histological confirmed hcc or clinical/laboratory diagnosis of hcc or nodules larger than 2 cm with typical vascular features or afp > 200
Description

Liver carcinoma | Nodule Size | Nodule Feature Vascular Typical | Alpha one fetoprotein measurement

Type de données

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2,1]
C0028259
UMLS CUI [2,2]
C0456389
UMLS CUI [3,1]
C0028259
UMLS CUI [3,2]
C2348519
UMLS CUI [3,3]
C1801960
UMLS CUI [3,4]
C3538928
UMLS CUI [4]
C0201539
3. patient must have quantifiable disease limited to the liver
Description

Measurable Disease Liver

Type de données

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0023884
4. patients must have at least one tumor lesion that meets both of the following criteria:
Description

Tumor Lesion Quantity | Criteria Fulfill

Type de données

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0243161
UMLS CUI [2,2]
C1550543
5. the lesion can be accurately measured in at least one dimension according to recist criteria
Description

Measurable lesion Dimension Quantity

Type de données

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0439534
UMLS CUI [1,3]
C1265611
6. the lesion has not been previously treated with surgery, radiation therapy, radiofrequency ablation, percutaneous ethanol or acetic acid injection, or cryoablation.
Description

Operative Surgical Procedures Absent | Therapeutic radiology procedure Absent | Radiofrequency ablation Absent | Percutaneous ethanol injection therapy Absent | Acetic Acid Injection Absent | Cryosurgery Absent

Type de données

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0850292
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C1535909
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0000983
UMLS CUI [5,2]
C1828121
UMLS CUI [5,3]
C0332197
UMLS CUI [6,1]
C0010408
UMLS CUI [6,2]
C0332197
7. ecog performance status (ps) <2
Description

ECOG performance status

Type de données

boolean

Alias
UMLS CUI [1]
C1520224
8. no prior targeted antiangiogenic therapy. metronomic chemotherapies are allowed. at least 4 weeks since prior systemic chemotherapy,at least 4 weeks since prior tace, at least 4 weeks since prior interferon.
Description

Antiangiogenic therapy Targeted Absent | Metronomic Chemotherapy | Systemic Chemotherapy | Transarterial Chemoembolization | Interferon

Type de données

boolean

Alias
UMLS CUI [1,1]
C2363719
UMLS CUI [1,2]
C1521840
UMLS CUI [1,3]
C0332197
UMLS CUI [2]
C1881814
UMLS CUI [3]
C1883256
UMLS CUI [4]
C3539919
UMLS CUI [5]
C3652465
9. not pregnant
Description

Pregnancy Absent

Type de données

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
10. no significant baseline liver dysfunction. cirrhotic status of child-pugh class a only
Description

Liver Dysfunction Absent | Status Cirrhotic Child-Pugh Classification

Type de données

boolean

Alias
UMLS CUI [1,1]
C0086565
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0449438
UMLS CUI [2,2]
C0439686
UMLS CUI [2,3]
C2347612
11. no significant renal impairment (creatinine clearance < 30 ml/minute) or patients on dialysis
Description

Renal Insufficiency Absent | Creatinine clearance measurement | Dialysis Absent

Type de données

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C0373595
UMLS CUI [3,1]
C0011946
UMLS CUI [3,2]
C0332197
12. no current infections requiring antibiotic therapy
Description

Exclusion | Communicable Diseases Requirement Antibiotic therapy

Type de données

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0338237
13. not on anticoagulation or suffering from a known bleeding disorder
Description

Anticoagulation Therapy Absent | Blood Coagulation Disorders Absent

Type de données

boolean

Alias
UMLS CUI [1,1]
C0003281
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0005779
UMLS CUI [2,2]
C0332197
14. no unstable coronary artery disease or recent mi
Description

Coronary Artery Disease Unstable Absent | Recent myocardial infarction Absent

Type de données

boolean

Alias
UMLS CUI [1,1]
C1956346
UMLS CUI [1,2]
C0443343
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C1998297
UMLS CUI [2,2]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. previous or concurrent cancer that is distinct in primary site or histology from hcc except cervical carcinoma in situ, treated basal-cell carcinoma of the skin, superficial bladder tumors (ta, tis & t1), and any cancer curatively treated > 3 years prior to entry is permitted
Description

Malignant Neoplasms Except Liver carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma Treated | Exception Superficial carcinoma of urinary bladder | Exception Curative treatment Malignant Neoplasms

Type de données

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0332300
UMLS CUI [1,3]
C2239176
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0851140
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1336527
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C1273390
UMLS CUI [5,3]
C0006826
2. renal failure requiring hemo- or peritoneal dialysis
Description

Kidney Failure Requirement Hemodialysis | Kidney Failure Requirement Peritoneal Dialysis

Type de données

boolean

Alias
UMLS CUI [1,1]
C0035078
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0019004
UMLS CUI [2,1]
C0035078
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0031139
3. child-pugh b & c hepatic impairment
Description

Hepatic impairment Child-Pugh Classification

Type de données

boolean

Alias
UMLS CUI [1,1]
C0948807
UMLS CUI [1,2]
C2347612
4. history of cardiac disease: > ny heart association (nyha) class 2 congestive heart failure, active coronary artery disease, cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin, and uncontrolled hypertension. myocardial infarction more than 6 months prior to study entry is permitted.
Description

Heart Disease | Congestive heart failure New York Heart Association Classification | Coronary Artery Disease | Cardiac Arrhythmia Requirement Anti-Arrhythmia Agents | Exception Adrenergic beta-1 Receptor Antagonists | Exception Digoxin | Uncontrolled hypertension | Myocardial Infarction Previous allowed

Type de données

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2,1]
C0018802
UMLS CUI [2,2]
C1275491
UMLS CUI [3]
C1956346
UMLS CUI [4,1]
C0003811
UMLS CUI [4,2]
C1514873
UMLS CUI [4,3]
C0003195
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0304516
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0012265
UMLS CUI [7]
C1868885
UMLS CUI [8,1]
C0027051
UMLS CUI [8,2]
C0205156
UMLS CUI [8,3]
C0683607
5. active clinically serious infections (> ctcaev3 grade 2)
Description

Communicable Diseases Serious CTCAE Grades

Type de données

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C1516728
6. known history of hiv
Description

HIV Infection

Type de données

boolean

Alias
UMLS CUI [1]
C0019693
7. known central nervous system tumors including metastatic brain disease
Description

Central Nervous System Neoplasms | Metastatic malignant neoplasm to brain

Type de données

boolean

Alias
UMLS CUI [1]
C0085136
UMLS CUI [2]
C0220650
8. history of organ allograft
Description

Organ allograft

Type de données

boolean

Alias
UMLS CUI [1,1]
C0178784
UMLS CUI [1,2]
C0040739
9. substance abuse (current), psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
Description

Substance Use Disorders | Mental condition Interferes with Study Subject Participation Status | Social Conditions Interfere with Study Subject Participation Status | Mental condition Interferes with Evaluation Research results | Social Conditions Interfere with Evaluation Research results

Type de données

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2348568
UMLS CUI [3,1]
C0037403
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C2348568
UMLS CUI [4,1]
C3840291
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C1261322
UMLS CUI [4,4]
C0683954
UMLS CUI [5,1]
C0037403
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C1261322
UMLS CUI [5,4]
C0683954
10. known or suspected allergy to the investigational agents or any agent given in association with this trial.
Description

Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs

Type de données

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0750491
UMLS CUI [2,3]
C0013230
11. patients unable to swallow oral medications.
Description

Lacking Able to swallow Oral medication

Type de données

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2712086
UMLS CUI [1,3]
C0175795
12. pregnant or breast-feeding patients. women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of the study drug. both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial.
Description

Pregnancy | Breast Feeding | Childbearing Potential Pregnancy test negative | Gender Barrier Contraception

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0427780
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0004764
13. cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
Description

Ventricular arrhythmia Requirement Anti-Arrhythmia Agents

Type de données

boolean

Alias
UMLS CUI [1,1]
C0085612
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0003195
14. uncontrolled hypertension defined as systolic blood pressure > 150 mmhg or diastolic blood pressure > 90 mmhg, despite optimal medical management
Description

Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure | Disease Management Optimal

Type de données

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
UMLS CUI [4,1]
C0376636
UMLS CUI [4,2]
C2698651
15. thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months
Description

Thrombosis | Embolism | Cerebrovascular accident | Transient Ischemic Attack

Type de données

boolean

Alias
UMLS CUI [1]
C0040053
UMLS CUI [2]
C0013922
UMLS CUI [3]
C0038454
UMLS CUI [4]
C0007787
16. pulmonary hemorrhage/bleeding event > ctcae grade 2 within 4 weeks of first dose of study drug
Description

Pulmonary hemorrhage CTCAE Grades

Type de données

boolean

Alias
UMLS CUI [1,1]
C0151701
UMLS CUI [1,2]
C1516728
17. any other hemorrhage/bleeding event > ctcae grade 3 within 4 weeks of first dose of study drug
Description

Hemorrhage CTCAE Grades

Type de données

boolean

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C1516728
18. serious non-healing wound, ulcer, or bone fracture
Description

Non-healing wound Serious | Ulcer | Bone fracture

Type de données

boolean

Alias
UMLS CUI [1,1]
C0750433
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0041582
UMLS CUI [3]
C0016658
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Similar models

Eligibility Hepatocellular Carcinoma NCT01833299

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age | Liver carcinoma Inappropriate Excision | Liver carcinoma Inappropriate Local Ablation Therapy
Item
1. adults patients ( 18-75 years of age) with a diagnosis of hcc which is not amenable to surgical resection or local ablative therapy
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C2239176 (UMLS CUI [3,1])
C1548788 (UMLS CUI [3,2])
C0728940 (UMLS CUI [3,3])
C2239176 (UMLS CUI [4,1])
C1548788 (UMLS CUI [4,2])
C0547070 (UMLS CUI [4,3])
Liver carcinoma | Nodule Size | Nodule Feature Vascular Typical | Alpha one fetoprotein measurement
Item
2. histological confirmed hcc or clinical/laboratory diagnosis of hcc or nodules larger than 2 cm with typical vascular features or afp > 200
boolean
C2239176 (UMLS CUI [1])
C0028259 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0028259 (UMLS CUI [3,1])
C2348519 (UMLS CUI [3,2])
C1801960 (UMLS CUI [3,3])
C3538928 (UMLS CUI [3,4])
C0201539 (UMLS CUI [4])
Measurable Disease Liver
Item
3. patient must have quantifiable disease limited to the liver
boolean
C1513041 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
Tumor Lesion Quantity | Criteria Fulfill
Item
4. patients must have at least one tumor lesion that meets both of the following criteria:
boolean
C0027651 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0243161 (UMLS CUI [2,1])
C1550543 (UMLS CUI [2,2])
Measurable lesion Dimension Quantity
Item
5. the lesion can be accurately measured in at least one dimension according to recist criteria
boolean
C1513041 (UMLS CUI [1,1])
C0439534 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Operative Surgical Procedures Absent | Therapeutic radiology procedure Absent | Radiofrequency ablation Absent | Percutaneous ethanol injection therapy Absent | Acetic Acid Injection Absent | Cryosurgery Absent
Item
6. the lesion has not been previously treated with surgery, radiation therapy, radiofrequency ablation, percutaneous ethanol or acetic acid injection, or cryoablation.
boolean
C0543467 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0850292 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C1535909 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0000983 (UMLS CUI [5,1])
C1828121 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
C0010408 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
ECOG performance status
Item
7. ecog performance status (ps) <2
boolean
C1520224 (UMLS CUI [1])
Antiangiogenic therapy Targeted Absent | Metronomic Chemotherapy | Systemic Chemotherapy | Transarterial Chemoembolization | Interferon
Item
8. no prior targeted antiangiogenic therapy. metronomic chemotherapies are allowed. at least 4 weeks since prior systemic chemotherapy,at least 4 weeks since prior tace, at least 4 weeks since prior interferon.
boolean
C2363719 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C1881814 (UMLS CUI [2])
C1883256 (UMLS CUI [3])
C3539919 (UMLS CUI [4])
C3652465 (UMLS CUI [5])
Pregnancy Absent
Item
9. not pregnant
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Liver Dysfunction Absent | Status Cirrhotic Child-Pugh Classification
Item
10. no significant baseline liver dysfunction. cirrhotic status of child-pugh class a only
boolean
C0086565 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0449438 (UMLS CUI [2,1])
C0439686 (UMLS CUI [2,2])
C2347612 (UMLS CUI [2,3])
Renal Insufficiency Absent | Creatinine clearance measurement | Dialysis Absent
Item
11. no significant renal impairment (creatinine clearance < 30 ml/minute) or patients on dialysis
boolean
C1565489 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0373595 (UMLS CUI [2])
C0011946 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Exclusion | Communicable Diseases Requirement Antibiotic therapy
Item
12. no current infections requiring antibiotic therapy
boolean
C0680251 (UMLS CUI [1])
C0009450 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0338237 (UMLS CUI [2,3])
Anticoagulation Therapy Absent | Blood Coagulation Disorders Absent
Item
13. not on anticoagulation or suffering from a known bleeding disorder
boolean
C0003281 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0005779 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Coronary Artery Disease Unstable Absent | Recent myocardial infarction Absent
Item
14. no unstable coronary artery disease or recent mi
boolean
C1956346 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C1998297 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Malignant Neoplasms Except Liver carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma Treated | Exception Superficial carcinoma of urinary bladder | Exception Curative treatment Malignant Neoplasms
Item
1. previous or concurrent cancer that is distinct in primary site or histology from hcc except cervical carcinoma in situ, treated basal-cell carcinoma of the skin, superficial bladder tumors (ta, tis & t1), and any cancer curatively treated > 3 years prior to entry is permitted
boolean
C0006826 (UMLS CUI [1,1])
C0332300 (UMLS CUI [1,2])
C2239176 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1336527 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C1273390 (UMLS CUI [5,2])
C0006826 (UMLS CUI [5,3])
Kidney Failure Requirement Hemodialysis | Kidney Failure Requirement Peritoneal Dialysis
Item
2. renal failure requiring hemo- or peritoneal dialysis
boolean
C0035078 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0019004 (UMLS CUI [1,3])
C0035078 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0031139 (UMLS CUI [2,3])
Hepatic impairment Child-Pugh Classification
Item
3. child-pugh b & c hepatic impairment
boolean
C0948807 (UMLS CUI [1,1])
C2347612 (UMLS CUI [1,2])
Heart Disease | Congestive heart failure New York Heart Association Classification | Coronary Artery Disease | Cardiac Arrhythmia Requirement Anti-Arrhythmia Agents | Exception Adrenergic beta-1 Receptor Antagonists | Exception Digoxin | Uncontrolled hypertension | Myocardial Infarction Previous allowed
Item
4. history of cardiac disease: > ny heart association (nyha) class 2 congestive heart failure, active coronary artery disease, cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin, and uncontrolled hypertension. myocardial infarction more than 6 months prior to study entry is permitted.
boolean
C0018799 (UMLS CUI [1])
C0018802 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C1956346 (UMLS CUI [3])
C0003811 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0003195 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0304516 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0012265 (UMLS CUI [6,2])
C1868885 (UMLS CUI [7])
C0027051 (UMLS CUI [8,1])
C0205156 (UMLS CUI [8,2])
C0683607 (UMLS CUI [8,3])
Communicable Diseases Serious CTCAE Grades
Item
5. active clinically serious infections (> ctcaev3 grade 2)
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
HIV Infection
Item
6. known history of hiv
boolean
C0019693 (UMLS CUI [1])
Central Nervous System Neoplasms | Metastatic malignant neoplasm to brain
Item
7. known central nervous system tumors including metastatic brain disease
boolean
C0085136 (UMLS CUI [1])
C0220650 (UMLS CUI [2])
Organ allograft
Item
8. history of organ allograft
boolean
C0178784 (UMLS CUI [1,1])
C0040739 (UMLS CUI [1,2])
Substance Use Disorders | Mental condition Interferes with Study Subject Participation Status | Social Conditions Interfere with Study Subject Participation Status | Mental condition Interferes with Evaluation Research results | Social Conditions Interfere with Evaluation Research results
Item
9. substance abuse (current), psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
boolean
C0038586 (UMLS CUI [1])
C3840291 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C0037403 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C3840291 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C1261322 (UMLS CUI [4,3])
C0683954 (UMLS CUI [4,4])
C0037403 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C1261322 (UMLS CUI [5,3])
C0683954 (UMLS CUI [5,4])
Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs
Item
10. known or suspected allergy to the investigational agents or any agent given in association with this trial.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
Lacking Able to swallow Oral medication
Item
11. patients unable to swallow oral medications.
boolean
C0332268 (UMLS CUI [1,1])
C2712086 (UMLS CUI [1,2])
C0175795 (UMLS CUI [1,3])
Pregnancy | Breast Feeding | Childbearing Potential Pregnancy test negative | Gender Barrier Contraception
Item
12. pregnant or breast-feeding patients. women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of the study drug. both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0427780 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4,1])
C0004764 (UMLS CUI [4,2])
Ventricular arrhythmia Requirement Anti-Arrhythmia Agents
Item
13. cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
boolean
C0085612 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0003195 (UMLS CUI [1,3])
Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure | Disease Management Optimal
Item
14. uncontrolled hypertension defined as systolic blood pressure > 150 mmhg or diastolic blood pressure > 90 mmhg, despite optimal medical management
boolean
C1868885 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
C0376636 (UMLS CUI [4,1])
C2698651 (UMLS CUI [4,2])
Thrombosis | Embolism | Cerebrovascular accident | Transient Ischemic Attack
Item
15. thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months
boolean
C0040053 (UMLS CUI [1])
C0013922 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0007787 (UMLS CUI [4])
Pulmonary hemorrhage CTCAE Grades
Item
16. pulmonary hemorrhage/bleeding event > ctcae grade 2 within 4 weeks of first dose of study drug
boolean
C0151701 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Hemorrhage CTCAE Grades
Item
17. any other hemorrhage/bleeding event > ctcae grade 3 within 4 weeks of first dose of study drug
boolean
C0019080 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Non-healing wound Serious | Ulcer | Bone fracture
Item
18. serious non-healing wound, ulcer, or bone fracture
boolean
C0750433 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0041582 (UMLS CUI [2])
C0016658 (UMLS CUI [3])
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