ID

36265

Description

ONC201 in Relapsed/Refractory Acute Leukemias and High-risk Myelodysplastic Syndromes (HR-MDS); ODM derived from: https://clinicaltrials.gov/show/NCT02392572

Link

https://clinicaltrials.gov/show/NCT02392572

Keywords

Versions (1)
  1. 4/26/19 4/26/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 26, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Leukemia NCT02392572

English

Eligibility Leukemia NCT02392572

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT02392572
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients must have relapsed or refractory acute leukemias or high-risk mds for which no standard therapies are anticipated to result in a durable remission.
Description

Acute leukemia Recurrent | Acute leukemia Refractory | MYELODYSPLASTIC SYNDROME High risk | Standard therapy Unsuccessful | Disease remission Unlikely

Data type

boolean

Alias
UMLS CUI [1,1]
C0085669
UMLS CUI [1,2]
C2945760
UMLS CUI [2,1]
C0085669
UMLS CUI [2,2]
C0205269
UMLS CUI [3,1]
C3463824
UMLS CUI [3,2]
C4319571
UMLS CUI [4,1]
C2936643
UMLS CUI [4,2]
C1272705
UMLS CUI [5,1]
C0544452
UMLS CUI [5,2]
C0750558
2. age >/=18 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
3. eastern cooperative oncology group (ecog) performance status of 0-2.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
4. women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (abstinence, intrauterine device [iud], oral contraceptive or double barrier device, such as a condom, diaphragm, or cervical/vault cap), for 16 weeks after the last dose of study drug, and must have a negative serum or urine pregnancy test within 1 week prior to beginning treatment on this trial. nursing patients are excluded. sexually active men must also use acceptable contraceptive methods for the duration of time on study and for at least 16 weeks after the last dose of study drug. pregnant and nursing patients are excluded because the effects of onc201on a fetus or nursing child are unknown.
Description

Childbearing Potential Contraceptive methods | Premenopausal state | Female Sterilization Absent | Sexual Abstinence | Intrauterine Devices | Contraceptives, Oral | Barrier Contraception Double | Female Condoms | Vaginal contraceptive diaphragm | CERVICAL CAP FOR CONTRACEPTIVE USE | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | Breast Feeding Excluded | Gender Sexually active Contraceptive methods | Pregnancy Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0232969
UMLS CUI [3,1]
C0015787
UMLS CUI [3,2]
C0332197
UMLS CUI [4]
C0036899
UMLS CUI [5]
C0021900
UMLS CUI [6]
C0009905
UMLS CUI [7,1]
C0004764
UMLS CUI [7,2]
C0205173
UMLS CUI [8]
C0221829
UMLS CUI [9]
C0042241
UMLS CUI [10]
C0493327
UMLS CUI [11,1]
C3831118
UMLS CUI [11,2]
C0430061
UMLS CUI [12,1]
C3831118
UMLS CUI [12,2]
C0430057
UMLS CUI [13,1]
C0006147
UMLS CUI [13,2]
C0332196
UMLS CUI [14,1]
C0079399
UMLS CUI [14,2]
C0241028
UMLS CUI [14,3]
C0700589
UMLS CUI [15,1]
C0032961
UMLS CUI [15,2]
C0332196
5. must be able and willing to give written informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
6. the interval from prior treatment to time of study drug administration should be at least 2 weeks for cytotoxic agents or at least 5 half-lives for noncytotoxic agents. if the patient is on hydroxyurea to control peripheral blood leukemic cell counts, the patient must be off hydroxyurea for at least 24 hours before initiation of treatment on this protocol. persistent clinically significant toxicities from prior therapy must not be greater than grade 1.
Description

Cytotoxic agent | Pharmaceutical Preparations Except Cytotoxic agent | hydroxyurea | Blood Cell Count Peripheral Leukemic | Prior Therapy Toxicity CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1]
C0304497
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C0304497
UMLS CUI [3]
C0020402
UMLS CUI [4,1]
C0005771
UMLS CUI [4,2]
C0229664
UMLS CUI [4,3]
C1517806
UMLS CUI [5,1]
C1514463
UMLS CUI [5,2]
C0600688
UMLS CUI [5,3]
C1516728
7. patients must have the following clinical laboratory values unless considered due to leukemic organ involvement: (1) serum creatinine < 2.0 mg/dl; (2) total bilirubin </= 1.5 x the upper limit of normal (uln) unless considered due to gilbert's syndrome; (3) alanine aminotransferase (alt), or aspartate aminotransferase (ast) </= 3 x the uln unless considered due to organ leukemic involvement.
Description

Laboratory Results Required | Exception Involvement with Leukemia | Creatinine measurement, serum | Serum total bilirubin measurement | Exception Gilbert Disease | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Exception Involvement with Leukemia

Data type

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C1514873
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1314939
UMLS CUI [2,3]
C0023418
UMLS CUI [3]
C0201976
UMLS CUI [4]
C1278039
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0017551
UMLS CUI [6]
C0201836
UMLS CUI [7]
C0201899
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C1314939
UMLS CUI [8,3]
C0023418
8. patients with known central nervous system (cns) disease are allowed if there is no evidence of active cns disease as documented by negative imaging or spinal fluid analysis carried out at least 2 weeks prior to study drug administration. information obtained from standard of care historical data will be used for this purpose.
Description

CNS disorder | Imaging Negative | Spinal Fluid Analysis Negative

Data type

boolean

Alias
UMLS CUI [1]
C0007682
UMLS CUI [2,1]
C0011923
UMLS CUI [2,2]
C1513916
UMLS CUI [3,1]
C0007806
UMLS CUI [3,2]
C0002778
UMLS CUI [3,3]
C1513916
9. relapse > 6 months since autologous or allogeneic stem cell transplantation provided: (1) no active graft-versus-host disease (gvhd > grade 1); (2) no treatment with high dose steroids for gvhd (up to >/= 20 mg prednisolone or equivalent per day); (3) no treatment with immunosuppressive drugs with the exception of low dose cyclosporine and tacrolimus.
Description

Recurrent disease | Status post Transplantation of autologous hematopoietic stem cell | Status post Allogeneic Stem Cell Transplantation | Graft-vs-Host Disease Grade Absent | Absence Steroids High dose Graft-vs-Host Disease | Prednisolone Dose U/day | Equivalent | Immunosuppressive Agents Absent | Exception Cyclosporine Low dose | Exception Tacrolimus Low dose

Data type

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C1831743
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C2242529
UMLS CUI [4,1]
C0018133
UMLS CUI [4,2]
C0441800
UMLS CUI [4,3]
C0332197
UMLS CUI [5,1]
C0332197
UMLS CUI [5,2]
C0038317
UMLS CUI [5,3]
C0444956
UMLS CUI [5,4]
C0018133
UMLS CUI [6,1]
C0032950
UMLS CUI [6,2]
C0178602
UMLS CUI [6,3]
C0456683
UMLS CUI [7]
C0205163
UMLS CUI [8,1]
C0021081
UMLS CUI [8,2]
C0332197
UMLS CUI [9,1]
C1705847
UMLS CUI [9,2]
C0010592
UMLS CUI [9,3]
C0445550
UMLS CUI [10,1]
C1705847
UMLS CUI [10,2]
C0085149
UMLS CUI [10,3]
C0445550
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. uncontrolled intercurrent illness including, but not limited to uncontrolled infection, symptomatic congestive heart failure (new york heart association class iii and iv), uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Description

Comorbidity Uncontrolled | Communicable Disease Uncontrolled | Symptomatic congestive heart failure New York Heart Association Classification | Cardiac Arrhythmia Uncontrolled | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C0742758
UMLS CUI [3,2]
C1275491
UMLS CUI [4,1]
C0003811
UMLS CUI [4,2]
C0205318
UMLS CUI [5,1]
C0004936
UMLS CUI [5,2]
C0439801
UMLS CUI [5,3]
C0525058
UMLS CUI [6,1]
C0748872
UMLS CUI [6,2]
C0439801
UMLS CUI [6,3]
C0525058
2. active heart disease including myocardial infarction within previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medication, or uncontrolled congestive heart failure (new york heart association class iii and iv).
Description

Heart Disease | Myocardial Infarction | Coronary Artery Disease Symptomatic | Cardiac Arrhythmia Uncontrolled | Congestive heart failure Uncontrolled New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0027051
UMLS CUI [3,1]
C1956346
UMLS CUI [3,2]
C0231220
UMLS CUI [4,1]
C0003811
UMLS CUI [4,2]
C0205318
UMLS CUI [5,1]
C0018802
UMLS CUI [5,2]
C0205318
UMLS CUI [5,3]
C1275491
3. patients receiving any other standard or investigational treatment for their hematologic malignancy within past 2 weeks for cytotoxic agents or at least 5 half-lives for noncytotoxic agents.
Description

Standard therapy Hematologic Neoplasms | Investigational Therapy Hematologic Neoplasms | Cytotoxic agent | Pharmaceutical Preparations Except Cytotoxic agent

Data type

boolean

Alias
UMLS CUI [1,1]
C2936643
UMLS CUI [1,2]
C0376545
UMLS CUI [2,1]
C0949266
UMLS CUI [2,2]
C0376545
UMLS CUI [3]
C0304497
UMLS CUI [4,1]
C0013227
UMLS CUI [4,2]
C0332300
UMLS CUI [4,3]
C0304497
4. subject has been diagnosed or treated for another malignancy within 3 years of enrolment, except in situ malignancy, or low-risk prostate, skin or cervix cancer after curative therapy.
Description

Cancer Other | Cancer Other Treated | Exception Carcinoma in Situ | Exception Prostate carcinoma Low Risk | Exception Skin carcinoma Low Risk | Exception Cervix carcinoma Low Risk | Status post Curative treatment

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1707251
UMLS CUI [2,2]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007099
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0600139
UMLS CUI [4,3]
C3538919
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0699893
UMLS CUI [5,3]
C3538919
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0302592
UMLS CUI [6,3]
C3538919
UMLS CUI [7,1]
C0231290
UMLS CUI [7,2]
C1273390
5. known history of seropositive for human immunodeficiency virus (hiv) antibodies (hiv1 and hiv2), hepatitis c antibody (hep c ab) or a hepatitis b carrier (positive for hepatitis b surface antigen [hbsag])
Description

Seropositive Human immunodeficiency virus type 1 antibody | Seropositive Human immunodeficiency virus type II antibody | Seropositive Hepatitis C Antibodies | Hepatitis B carrier | Hepatitis B surface antigen positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0521143
UMLS CUI [1,2]
C0369497
UMLS CUI [2,1]
C0521143
UMLS CUI [2,2]
C0369500
UMLS CUI [3,1]
C0521143
UMLS CUI [3,2]
C0166049
UMLS CUI [4]
C0262505
UMLS CUI [5]
C0149709
6. active drug use or alcoholism.
Description

Drug Use Disorders | Alcoholic Intoxication, Chronic

Data type

boolean

Alias
UMLS CUI [1]
C0013222
UMLS CUI [2]
C0001973
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Similar models

Eligibility Leukemia NCT02392572

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT02392572
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Acute leukemia Recurrent | Acute leukemia Refractory | MYELODYSPLASTIC SYNDROME High risk | Standard therapy Unsuccessful | Disease remission Unlikely
Item
1. patients must have relapsed or refractory acute leukemias or high-risk mds for which no standard therapies are anticipated to result in a durable remission.
boolean
C0085669 (UMLS CUI [1,1])
C2945760 (UMLS CUI [1,2])
C0085669 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
C3463824 (UMLS CUI [3,1])
C4319571 (UMLS CUI [3,2])
C2936643 (UMLS CUI [4,1])
C1272705 (UMLS CUI [4,2])
C0544452 (UMLS CUI [5,1])
C0750558 (UMLS CUI [5,2])
Age
Item
2. age >/=18 years.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
3. eastern cooperative oncology group (ecog) performance status of 0-2.
boolean
C1520224 (UMLS CUI [1])
Childbearing Potential Contraceptive methods | Premenopausal state | Female Sterilization Absent | Sexual Abstinence | Intrauterine Devices | Contraceptives, Oral | Barrier Contraception Double | Female Condoms | Vaginal contraceptive diaphragm | CERVICAL CAP FOR CONTRACEPTIVE USE | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | Breast Feeding Excluded | Gender Sexually active Contraceptive methods | Pregnancy Excluded
Item
4. women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (abstinence, intrauterine device [iud], oral contraceptive or double barrier device, such as a condom, diaphragm, or cervical/vault cap), for 16 weeks after the last dose of study drug, and must have a negative serum or urine pregnancy test within 1 week prior to beginning treatment on this trial. nursing patients are excluded. sexually active men must also use acceptable contraceptive methods for the duration of time on study and for at least 16 weeks after the last dose of study drug. pregnant and nursing patients are excluded because the effects of onc201on a fetus or nursing child are unknown.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0232969 (UMLS CUI [2])
C0015787 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0036899 (UMLS CUI [4])
C0021900 (UMLS CUI [5])
C0009905 (UMLS CUI [6])
C0004764 (UMLS CUI [7,1])
C0205173 (UMLS CUI [7,2])
C0221829 (UMLS CUI [8])
C0042241 (UMLS CUI [9])
C0493327 (UMLS CUI [10])
C3831118 (UMLS CUI [11,1])
C0430061 (UMLS CUI [11,2])
C3831118 (UMLS CUI [12,1])
C0430057 (UMLS CUI [12,2])
C0006147 (UMLS CUI [13,1])
C0332196 (UMLS CUI [13,2])
C0079399 (UMLS CUI [14,1])
C0241028 (UMLS CUI [14,2])
C0700589 (UMLS CUI [14,3])
C0032961 (UMLS CUI [15,1])
C0332196 (UMLS CUI [15,2])
Informed Consent
Item
5. must be able and willing to give written informed consent.
boolean
C0021430 (UMLS CUI [1])
Cytotoxic agent | Pharmaceutical Preparations Except Cytotoxic agent | hydroxyurea | Blood Cell Count Peripheral Leukemic | Prior Therapy Toxicity CTCAE Grades
Item
6. the interval from prior treatment to time of study drug administration should be at least 2 weeks for cytotoxic agents or at least 5 half-lives for noncytotoxic agents. if the patient is on hydroxyurea to control peripheral blood leukemic cell counts, the patient must be off hydroxyurea for at least 24 hours before initiation of treatment on this protocol. persistent clinically significant toxicities from prior therapy must not be greater than grade 1.
boolean
C0304497 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0304497 (UMLS CUI [2,3])
C0020402 (UMLS CUI [3])
C0005771 (UMLS CUI [4,1])
C0229664 (UMLS CUI [4,2])
C1517806 (UMLS CUI [4,3])
C1514463 (UMLS CUI [5,1])
C0600688 (UMLS CUI [5,2])
C1516728 (UMLS CUI [5,3])
Laboratory Results Required | Exception Involvement with Leukemia | Creatinine measurement, serum | Serum total bilirubin measurement | Exception Gilbert Disease | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Exception Involvement with Leukemia
Item
7. patients must have the following clinical laboratory values unless considered due to leukemic organ involvement: (1) serum creatinine < 2.0 mg/dl; (2) total bilirubin </= 1.5 x the upper limit of normal (uln) unless considered due to gilbert's syndrome; (3) alanine aminotransferase (alt), or aspartate aminotransferase (ast) </= 3 x the uln unless considered due to organ leukemic involvement.
boolean
C1254595 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C0023418 (UMLS CUI [2,3])
C0201976 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C0017551 (UMLS CUI [5,2])
C0201836 (UMLS CUI [6])
C0201899 (UMLS CUI [7])
C1705847 (UMLS CUI [8,1])
C1314939 (UMLS CUI [8,2])
C0023418 (UMLS CUI [8,3])
CNS disorder | Imaging Negative | Spinal Fluid Analysis Negative
Item
8. patients with known central nervous system (cns) disease are allowed if there is no evidence of active cns disease as documented by negative imaging or spinal fluid analysis carried out at least 2 weeks prior to study drug administration. information obtained from standard of care historical data will be used for this purpose.
boolean
C0007682 (UMLS CUI [1])
C0011923 (UMLS CUI [2,1])
C1513916 (UMLS CUI [2,2])
C0007806 (UMLS CUI [3,1])
C0002778 (UMLS CUI [3,2])
C1513916 (UMLS CUI [3,3])
Recurrent disease | Status post Transplantation of autologous hematopoietic stem cell | Status post Allogeneic Stem Cell Transplantation | Graft-vs-Host Disease Grade Absent | Absence Steroids High dose Graft-vs-Host Disease | Prednisolone Dose U/day | Equivalent | Immunosuppressive Agents Absent | Exception Cyclosporine Low dose | Exception Tacrolimus Low dose
Item
9. relapse > 6 months since autologous or allogeneic stem cell transplantation provided: (1) no active graft-versus-host disease (gvhd > grade 1); (2) no treatment with high dose steroids for gvhd (up to >/= 20 mg prednisolone or equivalent per day); (3) no treatment with immunosuppressive drugs with the exception of low dose cyclosporine and tacrolimus.
boolean
C0277556 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C1831743 (UMLS CUI [2,2])
C0231290 (UMLS CUI [3,1])
C2242529 (UMLS CUI [3,2])
C0018133 (UMLS CUI [4,1])
C0441800 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C0332197 (UMLS CUI [5,1])
C0038317 (UMLS CUI [5,2])
C0444956 (UMLS CUI [5,3])
C0018133 (UMLS CUI [5,4])
C0032950 (UMLS CUI [6,1])
C0178602 (UMLS CUI [6,2])
C0456683 (UMLS CUI [6,3])
C0205163 (UMLS CUI [7])
C0021081 (UMLS CUI [8,1])
C0332197 (UMLS CUI [8,2])
C1705847 (UMLS CUI [9,1])
C0010592 (UMLS CUI [9,2])
C0445550 (UMLS CUI [9,3])
C1705847 (UMLS CUI [10,1])
C0085149 (UMLS CUI [10,2])
C0445550 (UMLS CUI [10,3])
Item Group
C0680251 (UMLS CUI)
Comorbidity Uncontrolled | Communicable Disease Uncontrolled | Symptomatic congestive heart failure New York Heart Association Classification | Cardiac Arrhythmia Uncontrolled | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
1. uncontrolled intercurrent illness including, but not limited to uncontrolled infection, symptomatic congestive heart failure (new york heart association class iii and iv), uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0742758 (UMLS CUI [3,1])
C1275491 (UMLS CUI [3,2])
C0003811 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0004936 (UMLS CUI [5,1])
C0439801 (UMLS CUI [5,2])
C0525058 (UMLS CUI [5,3])
C0748872 (UMLS CUI [6,1])
C0439801 (UMLS CUI [6,2])
C0525058 (UMLS CUI [6,3])
Heart Disease | Myocardial Infarction | Coronary Artery Disease Symptomatic | Cardiac Arrhythmia Uncontrolled | Congestive heart failure Uncontrolled New York Heart Association Classification
Item
2. active heart disease including myocardial infarction within previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medication, or uncontrolled congestive heart failure (new york heart association class iii and iv).
boolean
C0018799 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C1956346 (UMLS CUI [3,1])
C0231220 (UMLS CUI [3,2])
C0003811 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0018802 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
C1275491 (UMLS CUI [5,3])
Standard therapy Hematologic Neoplasms | Investigational Therapy Hematologic Neoplasms | Cytotoxic agent | Pharmaceutical Preparations Except Cytotoxic agent
Item
3. patients receiving any other standard or investigational treatment for their hematologic malignancy within past 2 weeks for cytotoxic agents or at least 5 half-lives for noncytotoxic agents.
boolean
C2936643 (UMLS CUI [1,1])
C0376545 (UMLS CUI [1,2])
C0949266 (UMLS CUI [2,1])
C0376545 (UMLS CUI [2,2])
C0304497 (UMLS CUI [3])
C0013227 (UMLS CUI [4,1])
C0332300 (UMLS CUI [4,2])
C0304497 (UMLS CUI [4,3])
Cancer Other | Cancer Other Treated | Exception Carcinoma in Situ | Exception Prostate carcinoma Low Risk | Exception Skin carcinoma Low Risk | Exception Cervix carcinoma Low Risk | Status post Curative treatment
Item
4. subject has been diagnosed or treated for another malignancy within 3 years of enrolment, except in situ malignancy, or low-risk prostate, skin or cervix cancer after curative therapy.
boolean
C1707251 (UMLS CUI [1])
C1707251 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007099 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0600139 (UMLS CUI [4,2])
C3538919 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0699893 (UMLS CUI [5,2])
C3538919 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0302592 (UMLS CUI [6,2])
C3538919 (UMLS CUI [6,3])
C0231290 (UMLS CUI [7,1])
C1273390 (UMLS CUI [7,2])
Seropositive Human immunodeficiency virus type 1 antibody | Seropositive Human immunodeficiency virus type II antibody | Seropositive Hepatitis C Antibodies | Hepatitis B carrier | Hepatitis B surface antigen positive
Item
5. known history of seropositive for human immunodeficiency virus (hiv) antibodies (hiv1 and hiv2), hepatitis c antibody (hep c ab) or a hepatitis b carrier (positive for hepatitis b surface antigen [hbsag])
boolean
C0521143 (UMLS CUI [1,1])
C0369497 (UMLS CUI [1,2])
C0521143 (UMLS CUI [2,1])
C0369500 (UMLS CUI [2,2])
C0521143 (UMLS CUI [3,1])
C0166049 (UMLS CUI [3,2])
C0262505 (UMLS CUI [4])
C0149709 (UMLS CUI [5])
Drug Use Disorders | Alcoholic Intoxication, Chronic
Item
6. active drug use or alcoholism.
boolean
C0013222 (UMLS CUI [1])
C0001973 (UMLS CUI [2])
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