ID

39631

Description

Pilot Trial of Bavituximab Combined With Ribavirin for Initial Treatment of Chronic HepC Virus Genotype 1 Infection; ODM derived from: https://clinicaltrials.gov/show/NCT01273948

Link

https://clinicaltrials.gov/show/NCT01273948

Keywords

Versions (1)
  1. 2/5/20 2/5/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 5, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT01273948

English

Eligibility Hepatitis C NCT01273948

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male or female between the ages of 18 and 65 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. chronic hepatitis c virus (hcv) genotype 1 infection
Description

Chronic Hepatitis C Genotype

Data type

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1533728
3. hcv rna level >10,000 iu/ml
Description

Hepatitis C virus RNA assay

Data type

boolean

Alias
UMLS CUI [1]
C1272251
4. chronic hcv infection, defined as:
Description

Hepatitis C, Chronic

Data type

boolean

Alias
UMLS CUI [1]
C0524910
previous documentation of positive hcv serology (hcv antibody or rna) at least 6 months (24 weeks) previously, or
Description

Serology positive Hepatitis C virus | Serology positive Hepatitis C Antibodies | Serology positive Hepatitis C virus RNA

Data type

boolean

Alias
UMLS CUI [1,1]
C0242089
UMLS CUI [1,2]
C0220847
UMLS CUI [2,1]
C0242089
UMLS CUI [2,2]
C0166049
UMLS CUI [3,1]
C0242089
UMLS CUI [3,2]
C0369335
positive hcv serology (hcv antibody or rna) with a prior remote (more than 6 months previously) risk factor for acquisition of hcv or
Description

Serology positive Hepatitis C virus | Serology positive Hepatitis C Antibodies | Serology positive Hepatitis C virus RNA | Risk factor Previous Hepatitis C virus

Data type

boolean

Alias
UMLS CUI [1,1]
C0242089
UMLS CUI [1,2]
C0220847
UMLS CUI [2,1]
C0242089
UMLS CUI [2,2]
C0166049
UMLS CUI [3,1]
C0242089
UMLS CUI [3,2]
C0369335
UMLS CUI [4,1]
C0035648
UMLS CUI [4,2]
C0205156
UMLS CUI [4,3]
C0220847
historical biopsy consistent with chronic hcv infection
Description

Biopsy Consistent with Chronic Hepatitis C

Data type

boolean

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C0524910
5. no clinically significant abnormalities in hematology, coagulation, or chemistry variables:
Description

Abnormality Absent Hematology | Abnormality Absent Blood coagulation | Abnormality Absent Chemical procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0200627
UMLS CUI [2,1]
C1704258
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0005778
UMLS CUI [3,1]
C1704258
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C0201682
hemoglobin >12 g/dl for women; >13 g/dl for men
Description

Hemoglobin measurement | Gender

Data type

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0079399
total white cell count >3000/mm3 and absolute neutrophil count >1500/mm3
Description

White Blood Cell Count procedure | Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0948762
platelets >100,000/mm3
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
prothrombin time (pt) and/or international normalized ratio (inr) less than or equal to 1.2 times the local upper limit of normal (uln)
Description

Prothrombin time assay | International Normalized Ratio

Data type

boolean

Alias
UMLS CUI [1]
C0033707
UMLS CUI [2]
C0525032
conjugated (direct) bilirubin less than or equal to 1.5 times the uln
Description

Serum conjugated bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278038
serum creatinine within normal limits
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
thyroid-stimulating hormone (tsh) and free thyroxine (t4) within normal limits
Description

Thyroid stimulating hormone measurement | T4 free measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202230
UMLS CUI [2]
C0202225
6. female patients: negative urine pregnancy test
Description

Gender Urine pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0430057
7. ability to provide informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. previous interferon-based antiviral therapy for chronic hcv infection
Description

Prior interferon therapy Chronic Hepatitis C

Data type

boolean

Alias
UMLS CUI [1,1]
C0278953
UMLS CUI [1,2]
C0524910
2. previous treatment with known immunogenic drugs
Description

Pharmaceutical Preparations immunogenic

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0872192
3. concomitant human immunodeficiency (hiv) or hepatitis b virus (hbv) infection
Description

Human immunodeficiency virus (HIV) coinfection | HBV coinfection

Data type

boolean

Alias
UMLS CUI [1]
C4062778
UMLS CUI [2]
C2242656
4. cause of liver disease other than chronic hcv infection, such as autoimmune or alcoholic liver disease
Description

Liver disease Independent of Chronic Hepatitis C | Autoimmune liver disease | Alcoholic Liver Diseases

Data type

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0332291
UMLS CUI [1,3]
C0524910
UMLS CUI [2]
C0400936
UMLS CUI [3]
C0023896
5. decompensated clinical liver disease, including a history of encephalopathy, bleeding esophageal or gastric varices, or ascites
Description

End Stage Liver Disease | Encephalopathy | Bleeding esophageal varices | Bleeding gastric varices

Data type

boolean

Alias
UMLS CUI [1]
C0745744
UMLS CUI [2]
C0085584
UMLS CUI [3]
C0155789
UMLS CUI [4]
C0267209
6. recipient of liver or other solid-organ transplantation
Description

Liver transplant recipient | Solid Organ Transplantation Recipient

Data type

boolean

Alias
UMLS CUI [1]
C3811922
UMLS CUI [2]
C4331301
7. evidence of clinically significant bleeding, defined as gross hematuria, hemoptysis, or gastrointestinal bleeding
Description

Hemorrhage Clinical Significance | Gross hematuria | Hemoptysis | Gastrointestinal Hemorrhage

Data type

boolean

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C0473237
UMLS CUI [3]
C0019079
UMLS CUI [4]
C0017181
8. history of bleeding diathesis or coagulopathy (eg, von willebrand disease or hemophilia)
Description

Bleeding tendency | Blood Coagulation Disorder | von Willebrand Disease | Hemophilia

Data type

boolean

Alias
UMLS CUI [1]
C1458140
UMLS CUI [2]
C0005779
UMLS CUI [3]
C0042974
UMLS CUI [4]
C0684275
9. history of thromboembolic events (eg, deep-vein thrombosis [dvt] or pulmonary embolism). previous central venous catheter-related thrombosis is acceptable if there is resolution recorded at least 12 months before enrollment.
Description

Thromboembolism | Deep Vein Thrombosis | Pulmonary Embolism

Data type

boolean

Alias
UMLS CUI [1]
C0040038
UMLS CUI [2]
C0149871
UMLS CUI [3]
C0034065
10. requirement for concurrent treatment with oral or parenteral anticoagulants or hormones (estrogen-containing contraceptives, hormone replacement, antiestrogen agents, progestins)
Description

Oral anticoagulants | Anticoagulants Parenteral | Hormones Oral | Hormones Parenteral | Contraceptive Agents Containing Estrogens | Hormone replacement therapy | Estrogen Antagonists | Progestins

Data type

boolean

Alias
UMLS CUI [1]
C0354604
UMLS CUI [2,1]
C0003280
UMLS CUI [2,2]
C1518896
UMLS CUI [3,1]
C0019932
UMLS CUI [3,2]
C1527415
UMLS CUI [4,1]
C0019932
UMLS CUI [4,2]
C1518896
UMLS CUI [5,1]
C0009871
UMLS CUI [5,2]
C0332256
UMLS CUI [5,3]
C0014939
UMLS CUI [6]
C0282402
UMLS CUI [7]
C0014930
UMLS CUI [8]
C0033306
11. condition requiring daily therapy with antiplatelet agents (eg, thienopyridines, dipyridamole, cilostazol; cardiovascular prophylaxis with aspirin is allowed) or corticosteroids
Description

Condition Treatment required Daily | Antiplatelet Agents | Thienopyridines | Dipyridamole | cilostazol | Adrenal Cortex Hormones

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0332121
UMLS CUI [1,3]
C0332173
UMLS CUI [2]
C0085826
UMLS CUI [3]
C2936588
UMLS CUI [4]
C0012582
UMLS CUI [5]
C0055729
UMLS CUI [6]
C0001617
12. investigational therapy within 28 days before the first planned dose of study drug
Description

Therapy, Investigational

Data type

boolean

Alias
UMLS CUI [1]
C0949266
13. major surgery within 28 days before the first planned dose of study drug
Description

Major surgery

Data type

boolean

Alias
UMLS CUI [1]
C0679637
14. uncontrolled intercurrent disease (eg, diabetes, hypertension, thyroid disease)
Description

Comorbidity Uncontrolled | Diabetic - poor control | Uncontrolled hypertension | Thyroid Disease Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0421258
UMLS CUI [3]
C1868885
UMLS CUI [4,1]
C0040128
UMLS CUI [4,2]
C0205318
15. ongoing angina pectoris or other symptoms of coronary artery disease (cad); history of stroke, or transient ischemic attack (tia)
Description

Angina Pectoris | Symptoms Coronary Artery Disease | Cerebrovascular accident | Transient Ischemic Attack

Data type

boolean

Alias
UMLS CUI [1]
C0002962
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C1956346
UMLS CUI [3]
C0038454
UMLS CUI [4]
C0007787
16. history of suicidal ideation or attempt
Description

Feeling suicidal | Suicide attempt

Data type

boolean

Alias
UMLS CUI [1]
C0424000
UMLS CUI [2]
C0038663
17. condition requiring treatment (past or current) with coumarin-type agents
Description

Condition Requirement Coumarins

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0010207
18. cardiac arrhythmia requiring medical therapy
Description

Cardiac Arrhythmia Treatment required for

Data type

boolean

Alias
UMLS CUI [1,1]
C0003811
UMLS CUI [1,2]
C0332121
19. serious nonhealing wound (including wound healing by secondary intention, ulcer, or bone fracture)
Description

Non healing wound Serious | Wound healing status: secondary intention | Ulcer | Fracture

Data type

boolean

Alias
UMLS CUI [1,1]
C0750433
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0518863
UMLS CUI [3]
C0041582
UMLS CUI [4]
C0016658
20. cancer, autoimmune disease, or any disease or concurrent therapy known to cause significant alteration in immune function (corticosteroids are allowed before study enrollment and during the study to treat an ae)
Description

Malignant Neoplasms | Autoimmune Disease | Disease Causing Alteration in immune functioning | Therapy Causing Alteration in immune functioning

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0004364
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0678227
UMLS CUI [3,3]
C4061464
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C0678227
UMLS CUI [4,3]
C4061464
21. female patients and female partners of male patients: pregnancy, lactation, or inability/unwillingness to practice effective contraception
Description

Pregnancy | Breast Feeding | Gender Contraceptive methods Unable | Gender Contraceptive methods Unwilling | Partner Contraceptive methods Unable | Partner Contraceptive methods Unwilling

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C1299582
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C0558080
UMLS CUI [5,1]
C0682323
UMLS CUI [5,2]
C0700589
UMLS CUI [5,3]
C1299582
UMLS CUI [6,1]
C0682323
UMLS CUI [6,2]
C0700589
UMLS CUI [6,3]
C0558080
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Similar models

Eligibility Hepatitis C NCT01273948

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. male or female between the ages of 18 and 65 years
boolean
C0001779 (UMLS CUI [1])
Chronic Hepatitis C Genotype
Item
2. chronic hepatitis c virus (hcv) genotype 1 infection
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Hepatitis C virus RNA assay
Item
3. hcv rna level >10,000 iu/ml
boolean
C1272251 (UMLS CUI [1])
Hepatitis C, Chronic
Item
4. chronic hcv infection, defined as:
boolean
C0524910 (UMLS CUI [1])
Serology positive Hepatitis C virus | Serology positive Hepatitis C Antibodies | Serology positive Hepatitis C virus RNA
Item
previous documentation of positive hcv serology (hcv antibody or rna) at least 6 months (24 weeks) previously, or
boolean
C0242089 (UMLS CUI [1,1])
C0220847 (UMLS CUI [1,2])
C0242089 (UMLS CUI [2,1])
C0166049 (UMLS CUI [2,2])
C0242089 (UMLS CUI [3,1])
C0369335 (UMLS CUI [3,2])
Serology positive Hepatitis C virus | Serology positive Hepatitis C Antibodies | Serology positive Hepatitis C virus RNA | Risk factor Previous Hepatitis C virus
Item
positive hcv serology (hcv antibody or rna) with a prior remote (more than 6 months previously) risk factor for acquisition of hcv or
boolean
C0242089 (UMLS CUI [1,1])
C0220847 (UMLS CUI [1,2])
C0242089 (UMLS CUI [2,1])
C0166049 (UMLS CUI [2,2])
C0242089 (UMLS CUI [3,1])
C0369335 (UMLS CUI [3,2])
C0035648 (UMLS CUI [4,1])
C0205156 (UMLS CUI [4,2])
C0220847 (UMLS CUI [4,3])
Biopsy Consistent with Chronic Hepatitis C
Item
historical biopsy consistent with chronic hcv infection
boolean
C0005558 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0524910 (UMLS CUI [1,3])
Abnormality Absent Hematology | Abnormality Absent Blood coagulation | Abnormality Absent Chemical procedure
Item
5. no clinically significant abnormalities in hematology, coagulation, or chemistry variables:
boolean
C1704258 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0200627 (UMLS CUI [1,3])
C1704258 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0005778 (UMLS CUI [2,3])
C1704258 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0201682 (UMLS CUI [3,3])
Hemoglobin measurement | Gender
Item
hemoglobin >12 g/dl for women; >13 g/dl for men
boolean
C0518015 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
White Blood Cell Count procedure | Absolute neutrophil count
Item
total white cell count >3000/mm3 and absolute neutrophil count >1500/mm3
boolean
C0023508 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
Platelet Count measurement
Item
platelets >100,000/mm3
boolean
C0032181 (UMLS CUI [1])
Prothrombin time assay | International Normalized Ratio
Item
prothrombin time (pt) and/or international normalized ratio (inr) less than or equal to 1.2 times the local upper limit of normal (uln)
boolean
C0033707 (UMLS CUI [1])
C0525032 (UMLS CUI [2])
Serum conjugated bilirubin measurement
Item
conjugated (direct) bilirubin less than or equal to 1.5 times the uln
boolean
C1278038 (UMLS CUI [1])
Creatinine measurement, serum
Item
serum creatinine within normal limits
boolean
C0201976 (UMLS CUI [1])
Thyroid stimulating hormone measurement | T4 free measurement
Item
thyroid-stimulating hormone (tsh) and free thyroxine (t4) within normal limits
boolean
C0202230 (UMLS CUI [1])
C0202225 (UMLS CUI [2])
Gender Urine pregnancy test negative
Item
6. female patients: negative urine pregnancy test
boolean
C0079399 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
Informed Consent
Item
7. ability to provide informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prior interferon therapy Chronic Hepatitis C
Item
1. previous interferon-based antiviral therapy for chronic hcv infection
boolean
C0278953 (UMLS CUI [1,1])
C0524910 (UMLS CUI [1,2])
Pharmaceutical Preparations immunogenic
Item
2. previous treatment with known immunogenic drugs
boolean
C0013227 (UMLS CUI [1,1])
C0872192 (UMLS CUI [1,2])
Human immunodeficiency virus (HIV) coinfection | HBV coinfection
Item
3. concomitant human immunodeficiency (hiv) or hepatitis b virus (hbv) infection
boolean
C4062778 (UMLS CUI [1])
C2242656 (UMLS CUI [2])
Liver disease Independent of Chronic Hepatitis C | Autoimmune liver disease | Alcoholic Liver Diseases
Item
4. cause of liver disease other than chronic hcv infection, such as autoimmune or alcoholic liver disease
boolean
C0023895 (UMLS CUI [1,1])
C0332291 (UMLS CUI [1,2])
C0524910 (UMLS CUI [1,3])
C0400936 (UMLS CUI [2])
C0023896 (UMLS CUI [3])
End Stage Liver Disease | Encephalopathy | Bleeding esophageal varices | Bleeding gastric varices
Item
5. decompensated clinical liver disease, including a history of encephalopathy, bleeding esophageal or gastric varices, or ascites
boolean
C0745744 (UMLS CUI [1])
C0085584 (UMLS CUI [2])
C0155789 (UMLS CUI [3])
C0267209 (UMLS CUI [4])
Liver transplant recipient | Solid Organ Transplantation Recipient
Item
6. recipient of liver or other solid-organ transplantation
boolean
C3811922 (UMLS CUI [1])
C4331301 (UMLS CUI [2])
Hemorrhage Clinical Significance | Gross hematuria | Hemoptysis | Gastrointestinal Hemorrhage
Item
7. evidence of clinically significant bleeding, defined as gross hematuria, hemoptysis, or gastrointestinal bleeding
boolean
C0019080 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0473237 (UMLS CUI [2])
C0019079 (UMLS CUI [3])
C0017181 (UMLS CUI [4])
Bleeding tendency | Blood Coagulation Disorder | von Willebrand Disease | Hemophilia
Item
8. history of bleeding diathesis or coagulopathy (eg, von willebrand disease or hemophilia)
boolean
C1458140 (UMLS CUI [1])
C0005779 (UMLS CUI [2])
C0042974 (UMLS CUI [3])
C0684275 (UMLS CUI [4])
Thromboembolism | Deep Vein Thrombosis | Pulmonary Embolism
Item
9. history of thromboembolic events (eg, deep-vein thrombosis [dvt] or pulmonary embolism). previous central venous catheter-related thrombosis is acceptable if there is resolution recorded at least 12 months before enrollment.
boolean
C0040038 (UMLS CUI [1])
C0149871 (UMLS CUI [2])
C0034065 (UMLS CUI [3])
Oral anticoagulants | Anticoagulants Parenteral | Hormones Oral | Hormones Parenteral | Contraceptive Agents Containing Estrogens | Hormone replacement therapy | Estrogen Antagonists | Progestins
Item
10. requirement for concurrent treatment with oral or parenteral anticoagulants or hormones (estrogen-containing contraceptives, hormone replacement, antiestrogen agents, progestins)
boolean
C0354604 (UMLS CUI [1])
C0003280 (UMLS CUI [2,1])
C1518896 (UMLS CUI [2,2])
C0019932 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C0019932 (UMLS CUI [4,1])
C1518896 (UMLS CUI [4,2])
C0009871 (UMLS CUI [5,1])
C0332256 (UMLS CUI [5,2])
C0014939 (UMLS CUI [5,3])
C0282402 (UMLS CUI [6])
C0014930 (UMLS CUI [7])
C0033306 (UMLS CUI [8])
Condition Treatment required Daily | Antiplatelet Agents | Thienopyridines | Dipyridamole | cilostazol | Adrenal Cortex Hormones
Item
11. condition requiring daily therapy with antiplatelet agents (eg, thienopyridines, dipyridamole, cilostazol; cardiovascular prophylaxis with aspirin is allowed) or corticosteroids
boolean
C0348080 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
C0085826 (UMLS CUI [2])
C2936588 (UMLS CUI [3])
C0012582 (UMLS CUI [4])
C0055729 (UMLS CUI [5])
C0001617 (UMLS CUI [6])
Therapy, Investigational
Item
12. investigational therapy within 28 days before the first planned dose of study drug
boolean
C0949266 (UMLS CUI [1])
Major surgery
Item
13. major surgery within 28 days before the first planned dose of study drug
boolean
C0679637 (UMLS CUI [1])
Comorbidity Uncontrolled | Diabetic - poor control | Uncontrolled hypertension | Thyroid Disease Uncontrolled
Item
14. uncontrolled intercurrent disease (eg, diabetes, hypertension, thyroid disease)
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0421258 (UMLS CUI [2])
C1868885 (UMLS CUI [3])
C0040128 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
Angina Pectoris | Symptoms Coronary Artery Disease | Cerebrovascular accident | Transient Ischemic Attack
Item
15. ongoing angina pectoris or other symptoms of coronary artery disease (cad); history of stroke, or transient ischemic attack (tia)
boolean
C0002962 (UMLS CUI [1])
C1457887 (UMLS CUI [2,1])
C1956346 (UMLS CUI [2,2])
C0038454 (UMLS CUI [3])
C0007787 (UMLS CUI [4])
Feeling suicidal | Suicide attempt
Item
16. history of suicidal ideation or attempt
boolean
C0424000 (UMLS CUI [1])
C0038663 (UMLS CUI [2])
Condition Requirement Coumarins
Item
17. condition requiring treatment (past or current) with coumarin-type agents
boolean
C0348080 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0010207 (UMLS CUI [1,3])
Cardiac Arrhythmia Treatment required for
Item
18. cardiac arrhythmia requiring medical therapy
boolean
C0003811 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
Non healing wound Serious | Wound healing status: secondary intention | Ulcer | Fracture
Item
19. serious nonhealing wound (including wound healing by secondary intention, ulcer, or bone fracture)
boolean
C0750433 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0518863 (UMLS CUI [2])
C0041582 (UMLS CUI [3])
C0016658 (UMLS CUI [4])
Malignant Neoplasms | Autoimmune Disease | Disease Causing Alteration in immune functioning | Therapy Causing Alteration in immune functioning
Item
20. cancer, autoimmune disease, or any disease or concurrent therapy known to cause significant alteration in immune function (corticosteroids are allowed before study enrollment and during the study to treat an ae)
boolean
C0006826 (UMLS CUI [1])
C0004364 (UMLS CUI [2])
C0012634 (UMLS CUI [3,1])
C0678227 (UMLS CUI [3,2])
C4061464 (UMLS CUI [3,3])
C0087111 (UMLS CUI [4,1])
C0678227 (UMLS CUI [4,2])
C4061464 (UMLS CUI [4,3])
Pregnancy | Breast Feeding | Gender Contraceptive methods Unable | Gender Contraceptive methods Unwilling | Partner Contraceptive methods Unable | Partner Contraceptive methods Unwilling
Item
21. female patients and female partners of male patients: pregnancy, lactation, or inability/unwillingness to practice effective contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
C0079399 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0558080 (UMLS CUI [4,3])
C0682323 (UMLS CUI [5,1])
C0700589 (UMLS CUI [5,2])
C1299582 (UMLS CUI [5,3])
C0682323 (UMLS CUI [6,1])
C0700589 (UMLS CUI [6,2])
C0558080 (UMLS CUI [6,3])
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