ID

39092

Description

Study of Ofatumomab in Combination With ICE-chemotherapy in Patients With Diffuse Large B-cell Lymphoma (DLBCL); ODM derived from: https://clinicaltrials.gov/show/NCT02412267

Link

https://clinicaltrials.gov/show/NCT02412267

Keywords

Versions (2)
  1. 11/30/19 11/30/19 -
  2. 12/1/19 12/1/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 1, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diffuse Large B-cell Lymphoma NCT02412267

English

Eligibility Diffuse Large B-cell Lymphoma NCT02412267

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. refractory or relapsed cd20 positive dlbcl following rituximab combined with chemotherapy.
Description

Diffuse large B-cell lymphoma refractory CD20 positive | Diffuse large B-cell lymphoma recurrent CD20 positive | Status post Combined Modality Therapy | rituximab | Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0855112
UMLS CUI [1,2]
C3888518
UMLS CUI [2,1]
C0855111
UMLS CUI [2,2]
C3888518
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0009429
UMLS CUI [4]
C0393022
UMLS CUI [5]
C0392920
2. participants must have measurable disease
Description

Measurable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
3. ecog performance status 0-2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
4. unless due to lymphomatous involvement, participants must have adequate organ and marrow function as defined below:
Description

Exception Involvement Lymphomatous | Organ function | Bone Marrow function

Data type

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C1314939
UMLS CUI [1,3]
C0024299
UMLS CUI [2]
C0678852
UMLS CUI [3,1]
C0005953
UMLS CUI [3,2]
C0031843
hemoglobin ≥ 10g/dl
Description

Hemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0518015
absolute neutrophil count ≥ 1500/mm3
Description

Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
platelets ≥ 100 000/mm3
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
alt and ast ≤ 3 x upper limit of normal (uln),
Description

Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
total serum bilirubin ≤ 1.5 x uln
Description

Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
serum creatinine ≤ 1.5 x uln
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
5. fully recovered (≤ grade 1 or returned to baseline or deemed irreversible) from the acute effects of prior cancer therapy before initiation of study drug
Description

Effects of Cancer treatment | Patient recovered CTCAE Grades | Return to Baseline | Irreversible toxic effect Assessed

Data type

boolean

Alias
UMLS CUI [1,1]
C1704420
UMLS CUI [1,2]
C0920425
UMLS CUI [2,1]
C1115804
UMLS CUI [2,2]
C1516728
UMLS CUI [3,1]
C0332156
UMLS CUI [3,2]
C1442488
UMLS CUI [4,1]
C0678774
UMLS CUI [4,2]
C1516048
6. ability to understand and the willingness to sign a written informed consent document
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. any previous cancer therapy for lymphoma, with the exception of rituximab in combination with chemotherapy (not more than 1 prior line of chemotherapy)
Description

Cancer treatment Lymphoma | Exception Combined Modality Therapy | rituximab | Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0024299
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0009429
UMLS CUI [3]
C0393022
UMLS CUI [4]
C0392920
2. participants who have had systemic anti-cancer therapy within 3 weeks (8 weeks for nitrosoureas or mitomycin c) prior to study entry
Description

Cancer treatment Systemic | Nitrosoureas | Mitomycin

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205373
UMLS CUI [2]
C0028210
UMLS CUI [3]
C0002475
3. participants who have had radiotherapy and/ or major surgery within 3 weeks prior to study entry
Description

Therapeutic radiology procedure | Major surgery

Data type

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2]
C0679637
4. participants who have had systemic corticosteroids for the purpose of treating lymphoma within 2 weeks prior to study entry are ineligible. patients receiving stable (not increased within the last month) chronic doses of systemic corticosteroids with a maximum dose of 20 mg of prednisolone (or equivalent) per day are eligible if they are being given for disorders other than lymphoma
Description

CORTICOSTEROIDS FOR SYSTEMIC USE Treating Lymphoma

Data type

boolean

Alias
UMLS CUI [1,1]
C3653708
UMLS CUI [1,2]
C1522326
UMLS CUI [1,3]
C0024299
5. concurrent use of any other anti-cancer therapies or study agents.
Description

Cancer treatment | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2]
C0013230
6. presence of symptomatic or uncontrolled brain or central nervous system lymphomatous lesions
Description

Primary cerebral lymphoma Symptomatic | Primary cerebral lymphoma Uncontrolled | Primary central nervous system lymphoma Symptomatic | Primary central nervous system lymphoma Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0240803
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C0240803
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C0280803
UMLS CUI [3,2]
C0231220
UMLS CUI [4,1]
C0280803
UMLS CUI [4,2]
C0205318
7. uncontrolled intercurrent illness including, but not limited to ongoing or active infection, clinically significant cardiac disease including a history of cardiac disease or congestive heart failure > nyha class 2, unstable angina (anginal symptoms at rest) or new-onset angina within the last 3 months or myocardial infarction within the past 6 months, significant cardiac arrhythmias and/ or requiring anti-arrhythmics; pulmonary disease; liver diseases such as cirrhosis, chronic active or persistent hepatitis; or acute/ chronic medical/ psychiatric illness/ social situations or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or limit compliance with study requirements, or interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.
Description

Comorbidity Uncontrolled | Communicable Disease | Heart Disease | Medical History Heart Disease | Congestive heart failure New York Heart Association Classification | Angina, Unstable | New onset angina | Myocardial Infarction | Cardiac Arrhythmia | Requirement Anti-Arrhythmia Agents | Lung disease | Liver disease | Liver Cirrhosis | Hepatitis, Chronic | Chronic Persistent Hepatitis | Disease Study Subject Participation Status At risk | Disease Investigational New Drugs At risk | Disease Limiting Protocol Compliance | Disease Interferes with Interpretation Research results | Disease Study Subject Participation Status Inappropriate | Chronic disease Study Subject Participation Status At risk | Mental disorders Study Subject Participation Status At risk | Chronic mental disorder Study Subject Participation Status At risk | Social situation Study Subject Participation Status At risk | LABORATORY ABNORMALITIES Study Subject Participation Status At risk

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0018799
UMLS CUI [4,1]
C0262926
UMLS CUI [4,2]
C0018799
UMLS CUI [5,1]
C0018802
UMLS CUI [5,2]
C1275491
UMLS CUI [6]
C0002965
UMLS CUI [7]
C0340289
UMLS CUI [8]
C0027051
UMLS CUI [9]
C0003811
UMLS CUI [10,1]
C1514873
UMLS CUI [10,2]
C0003195
UMLS CUI [11]
C0024115
UMLS CUI [12]
C0023895
UMLS CUI [13]
C0023890
UMLS CUI [14]
C0019189
UMLS CUI [15]
C0149519
UMLS CUI [16,1]
C0012634
UMLS CUI [16,2]
C2348568
UMLS CUI [16,3]
C1444641
UMLS CUI [17,1]
C0012634
UMLS CUI [17,2]
C0013230
UMLS CUI [17,3]
C1444641
UMLS CUI [18,1]
C0012634
UMLS CUI [18,2]
C0439801
UMLS CUI [18,3]
C0525058
UMLS CUI [19,1]
C0012634
UMLS CUI [19,2]
C0521102
UMLS CUI [19,3]
C0459471
UMLS CUI [19,4]
C0683954
UMLS CUI [20,1]
C0012634
UMLS CUI [20,2]
C2348568
UMLS CUI [20,3]
C1548788
UMLS CUI [21,1]
C0008679
UMLS CUI [21,2]
C2348568
UMLS CUI [21,3]
C1444641
UMLS CUI [22,1]
C0004936
UMLS CUI [22,2]
C2348568
UMLS CUI [22,3]
C1444641
UMLS CUI [23,1]
C0870281
UMLS CUI [23,2]
C2348568
UMLS CUI [23,3]
C1444641
UMLS CUI [24,1]
C0748872
UMLS CUI [24,2]
C2348568
UMLS CUI [24,3]
C1444641
UMLS CUI [25,1]
C1853129
UMLS CUI [25,2]
C2348568
UMLS CUI [25,3]
C1444641
8. known or suspected hypersensitivity to study treatments.
Description

Hypersensitivity Investigational Therapies | Hypersensitivity Suspected Investigational Therapies

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0949266
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0750491
UMLS CUI [2,3]
C0949266
9. history of hiv or hepatitis c
Description

HIV Infection | Hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019196
10. individuals with a history of a different malignancy, other than treated cervical cancer in situ, basal cell or squamous cell carcinoma of the skin, are ineligible, except if they have been disease-free for at least 5 years, and are deemed by the investigator to be at low risk for recurrence of that malignancy or other primary malignancy is neither currently clinically significant nor requiring active intervention.
Description

Cancer Other | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Disease Free Duration | Exception Low Risk Recurrent tumor

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0851140
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0553723
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0012634
UMLS CUI [5,3]
C0332296
UMLS CUI [5,4]
C0449238
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C3538919
UMLS CUI [6,3]
C0521158
11. pregnant or lactating women.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
12. women of childbearing potential, including women whose last menstrual period was less than one year prior to screening, unable or unwilling to use adequate contraception from study start to one year after the last dose of ofatumumab therapy. adequate contraception is defined as hormonal birth control, intrauterine device, double barrier method or total abstinence. women of childbearing potential must have a negative pregnancy test prior at screening.
Description

Childbearing Potential Contraceptive methods Unable | Childbearing Potential Contraceptive methods Unwilling | Premenopausal state Contraceptive methods Unable | Premenopausal state Contraceptive methods Unwilling | Hormonal contraception | Intrauterine Devices | Barrier Contraception Double | Sexual Abstinence | Childbearing Potential Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0558080
UMLS CUI [3,1]
C0232969
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C1299582
UMLS CUI [4,1]
C0232969
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C0558080
UMLS CUI [5]
C2985296
UMLS CUI [6]
C0021900
UMLS CUI [7,1]
C0004764
UMLS CUI [7,2]
C0205173
UMLS CUI [8]
C0036899
UMLS CUI [9,1]
C3831118
UMLS CUI [9,2]
C0427780
13. male subjects unable or unwilling to use adequate contraception methods from the time of first dose of study medication until one year after the last dose of ofatumumab.
Description

Gender Contraceptive methods Unable | Gender Contraceptive methods Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0558080
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Similar models

Eligibility Diffuse Large B-cell Lymphoma NCT02412267

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diffuse large B-cell lymphoma refractory CD20 positive | Diffuse large B-cell lymphoma recurrent CD20 positive | Status post Combined Modality Therapy | rituximab | Chemotherapy
Item
1. refractory or relapsed cd20 positive dlbcl following rituximab combined with chemotherapy.
boolean
C0855112 (UMLS CUI [1,1])
C3888518 (UMLS CUI [1,2])
C0855111 (UMLS CUI [2,1])
C3888518 (UMLS CUI [2,2])
C0231290 (UMLS CUI [3,1])
C0009429 (UMLS CUI [3,2])
C0393022 (UMLS CUI [4])
C0392920 (UMLS CUI [5])
Measurable Disease
Item
2. participants must have measurable disease
boolean
C1513041 (UMLS CUI [1])
ECOG performance status
Item
3. ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Exception Involvement Lymphomatous | Organ function | Bone Marrow function
Item
4. unless due to lymphomatous involvement, participants must have adequate organ and marrow function as defined below:
boolean
C1705847 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C0024299 (UMLS CUI [1,3])
C0678852 (UMLS CUI [2])
C0005953 (UMLS CUI [3,1])
C0031843 (UMLS CUI [3,2])
Hemoglobin measurement
Item
hemoglobin ≥ 10g/dl
boolean
C0518015 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophil count ≥ 1500/mm3
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelets ≥ 100 000/mm3
boolean
C0032181 (UMLS CUI [1])
Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
alt and ast ≤ 3 x upper limit of normal (uln),
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
Serum total bilirubin measurement
Item
total serum bilirubin ≤ 1.5 x uln
boolean
C1278039 (UMLS CUI [1])
Creatinine measurement, serum
Item
serum creatinine ≤ 1.5 x uln
boolean
C0201976 (UMLS CUI [1])
Effects of Cancer treatment | Patient recovered CTCAE Grades | Return to Baseline | Irreversible toxic effect Assessed
Item
5. fully recovered (≤ grade 1 or returned to baseline or deemed irreversible) from the acute effects of prior cancer therapy before initiation of study drug
boolean
C1704420 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C1115804 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
C0332156 (UMLS CUI [3,1])
C1442488 (UMLS CUI [3,2])
C0678774 (UMLS CUI [4,1])
C1516048 (UMLS CUI [4,2])
Informed Consent
Item
6. ability to understand and the willingness to sign a written informed consent document
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cancer treatment Lymphoma | Exception Combined Modality Therapy | rituximab | Chemotherapy
Item
1. any previous cancer therapy for lymphoma, with the exception of rituximab in combination with chemotherapy (not more than 1 prior line of chemotherapy)
boolean
C0920425 (UMLS CUI [1,1])
C0024299 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0009429 (UMLS CUI [2,2])
C0393022 (UMLS CUI [3])
C0392920 (UMLS CUI [4])
Cancer treatment Systemic | Nitrosoureas | Mitomycin
Item
2. participants who have had systemic anti-cancer therapy within 3 weeks (8 weeks for nitrosoureas or mitomycin c) prior to study entry
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0028210 (UMLS CUI [2])
C0002475 (UMLS CUI [3])
Therapeutic radiology procedure | Major surgery
Item
3. participants who have had radiotherapy and/ or major surgery within 3 weeks prior to study entry
boolean
C1522449 (UMLS CUI [1])
C0679637 (UMLS CUI [2])
CORTICOSTEROIDS FOR SYSTEMIC USE Treating Lymphoma
Item
4. participants who have had systemic corticosteroids for the purpose of treating lymphoma within 2 weeks prior to study entry are ineligible. patients receiving stable (not increased within the last month) chronic doses of systemic corticosteroids with a maximum dose of 20 mg of prednisolone (or equivalent) per day are eligible if they are being given for disorders other than lymphoma
boolean
C3653708 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C0024299 (UMLS CUI [1,3])
Cancer treatment | Investigational New Drugs
Item
5. concurrent use of any other anti-cancer therapies or study agents.
boolean
C0920425 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Primary cerebral lymphoma Symptomatic | Primary cerebral lymphoma Uncontrolled | Primary central nervous system lymphoma Symptomatic | Primary central nervous system lymphoma Uncontrolled
Item
6. presence of symptomatic or uncontrolled brain or central nervous system lymphomatous lesions
boolean
C0240803 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0240803 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0280803 (UMLS CUI [3,1])
C0231220 (UMLS CUI [3,2])
C0280803 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
Comorbidity Uncontrolled | Communicable Disease | Heart Disease | Medical History Heart Disease | Congestive heart failure New York Heart Association Classification | Angina, Unstable | New onset angina | Myocardial Infarction | Cardiac Arrhythmia | Requirement Anti-Arrhythmia Agents | Lung disease | Liver disease | Liver Cirrhosis | Hepatitis, Chronic | Chronic Persistent Hepatitis | Disease Study Subject Participation Status At risk | Disease Investigational New Drugs At risk | Disease Limiting Protocol Compliance | Disease Interferes with Interpretation Research results | Disease Study Subject Participation Status Inappropriate | Chronic disease Study Subject Participation Status At risk | Mental disorders Study Subject Participation Status At risk | Chronic mental disorder Study Subject Participation Status At risk | Social situation Study Subject Participation Status At risk | LABORATORY ABNORMALITIES Study Subject Participation Status At risk
Item
7. uncontrolled intercurrent illness including, but not limited to ongoing or active infection, clinically significant cardiac disease including a history of cardiac disease or congestive heart failure > nyha class 2, unstable angina (anginal symptoms at rest) or new-onset angina within the last 3 months or myocardial infarction within the past 6 months, significant cardiac arrhythmias and/ or requiring anti-arrhythmics; pulmonary disease; liver diseases such as cirrhosis, chronic active or persistent hepatitis; or acute/ chronic medical/ psychiatric illness/ social situations or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or limit compliance with study requirements, or interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0018799 (UMLS CUI [3])
C0262926 (UMLS CUI [4,1])
C0018799 (UMLS CUI [4,2])
C0018802 (UMLS CUI [5,1])
C1275491 (UMLS CUI [5,2])
C0002965 (UMLS CUI [6])
C0340289 (UMLS CUI [7])
C0027051 (UMLS CUI [8])
C0003811 (UMLS CUI [9])
C1514873 (UMLS CUI [10,1])
C0003195 (UMLS CUI [10,2])
C0024115 (UMLS CUI [11])
C0023895 (UMLS CUI [12])
C0023890 (UMLS CUI [13])
C0019189 (UMLS CUI [14])
C0149519 (UMLS CUI [15])
C0012634 (UMLS CUI [16,1])
C2348568 (UMLS CUI [16,2])
C1444641 (UMLS CUI [16,3])
C0012634 (UMLS CUI [17,1])
C0013230 (UMLS CUI [17,2])
C1444641 (UMLS CUI [17,3])
C0012634 (UMLS CUI [18,1])
C0439801 (UMLS CUI [18,2])
C0525058 (UMLS CUI [18,3])
C0012634 (UMLS CUI [19,1])
C0521102 (UMLS CUI [19,2])
C0459471 (UMLS CUI [19,3])
C0683954 (UMLS CUI [19,4])
C0012634 (UMLS CUI [20,1])
C2348568 (UMLS CUI [20,2])
C1548788 (UMLS CUI [20,3])
C0008679 (UMLS CUI [21,1])
C2348568 (UMLS CUI [21,2])
C1444641 (UMLS CUI [21,3])
C0004936 (UMLS CUI [22,1])
C2348568 (UMLS CUI [22,2])
C1444641 (UMLS CUI [22,3])
C0870281 (UMLS CUI [23,1])
C2348568 (UMLS CUI [23,2])
C1444641 (UMLS CUI [23,3])
C0748872 (UMLS CUI [24,1])
C2348568 (UMLS CUI [24,2])
C1444641 (UMLS CUI [24,3])
C1853129 (UMLS CUI [25,1])
C2348568 (UMLS CUI [25,2])
C1444641 (UMLS CUI [25,3])
Hypersensitivity Investigational Therapies | Hypersensitivity Suspected Investigational Therapies
Item
8. known or suspected hypersensitivity to study treatments.
boolean
C0020517 (UMLS CUI [1,1])
C0949266 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0949266 (UMLS CUI [2,3])
HIV Infection | Hepatitis C
Item
9. history of hiv or hepatitis c
boolean
C0019693 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
Cancer Other | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Disease Free Duration | Exception Low Risk Recurrent tumor
Item
10. individuals with a history of a different malignancy, other than treated cervical cancer in situ, basal cell or squamous cell carcinoma of the skin, are ineligible, except if they have been disease-free for at least 5 years, and are deemed by the investigator to be at low risk for recurrence of that malignancy or other primary malignancy is neither currently clinically significant nor requiring active intervention.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0012634 (UMLS CUI [5,2])
C0332296 (UMLS CUI [5,3])
C0449238 (UMLS CUI [5,4])
C1705847 (UMLS CUI [6,1])
C3538919 (UMLS CUI [6,2])
C0521158 (UMLS CUI [6,3])
Pregnancy | Breast Feeding
Item
11. pregnant or lactating women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Unable | Childbearing Potential Contraceptive methods Unwilling | Premenopausal state Contraceptive methods Unable | Premenopausal state Contraceptive methods Unwilling | Hormonal contraception | Intrauterine Devices | Barrier Contraception Double | Sexual Abstinence | Childbearing Potential Pregnancy test negative
Item
12. women of childbearing potential, including women whose last menstrual period was less than one year prior to screening, unable or unwilling to use adequate contraception from study start to one year after the last dose of ofatumumab therapy. adequate contraception is defined as hormonal birth control, intrauterine device, double barrier method or total abstinence. women of childbearing potential must have a negative pregnancy test prior at screening.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C0232969 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
C0232969 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0558080 (UMLS CUI [4,3])
C2985296 (UMLS CUI [5])
C0021900 (UMLS CUI [6])
C0004764 (UMLS CUI [7,1])
C0205173 (UMLS CUI [7,2])
C0036899 (UMLS CUI [8])
C3831118 (UMLS CUI [9,1])
C0427780 (UMLS CUI [9,2])
Gender Contraceptive methods Unable | Gender Contraceptive methods Unwilling
Item
13. male subjects unable or unwilling to use adequate contraception methods from the time of first dose of study medication until one year after the last dose of ofatumumab.
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
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