ID

41865

Description

Study ID: 110921 Clinical Study ID: 110921 Study Title: A Phase II Trial of Ofatumumab in Subjects with Waldenstrom's Macroglobulinemia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00811733 Clinicaltrials.gov Link: https://clinicaltrials.gov/ct2/show/NCT00811733 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Ofatumumab Trade Name: N/A Study Indication: Waldenstrom Macroglobulinaemia The primary objective of this open-label, multi-center, Phase II study was to evaluate the safety and efficacy of Ofatumumab in subjects diagnosed with Waldenstrom Macroglobulinaemia. For the study, eligible subjects were enrolled to receive up to 3 cycles of treatment with Ofatumumab. The first cycle consisted of a single dose of 300 mg followed by 3 weekly doses of 1000 mg (Treatment Group A) or 4 weekly doses of 2000 mg (Treatment Group B) of Ofatumumab, with response assessment beginning at Week 12. Based on the Week 12-16 response, eligible subjects could receive up to 2 additional cycles of treatment. This form has to be filled out at the Screening Visit.

Link

https://clinicaltrials.gov/ct2/show/NCT00811733

Keywords

Versions (1)
  1. 2/8/21 2/8/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

February 8, 2021

DOI

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License

Creative Commons BY-NC 4.0
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GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733

English

Eligibility Criteria

1 forms  
  1. StudyEvent: ODM
    1. Eligibility Criteria
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
date of visit/assessment
Description

date of visit/assessment

Data type

date

Alias
UMLS CUI [1]
C1320303
UMLS CUI [2]
C2985720
subject number
Description

subject ID

Data type

text

Alias
UMLS CUI [1]
C2348585
Eligibility Question
Description

Eligibility Question

Alias
UMLS CUI-1
C0013893
Did the subject meet all the entry criteria?
Description

if no, please select all boxes corresponding to violations of any inclusion/exclusion criteria

Data type

boolean

Alias
UMLS CUI [1]
C1516637
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Diagnosis of Waldenstrom's macroglobulinemia as defined by the criteria established from the 2nd International workshop on WM
Description

The criteria are: - IgM monoclonal gammopathy of any concentration - Bone marrow infiltration by small lymphocytes, plasmacytoid cells, and plasma cells - Diffuse, interstitial, or nodular pattern of bone marrow infiltration - Surface IgM+, CD10-, CD20+, CD23

Data type

boolean

Alias
UMLS CUI [1,1]
C0024419
UMLS CUI [1,2]
C0679228
Requiring therapy based upon the criteria established by the consensus panel from the 2nd International Workshop on WM.
Description

Subjects must meet at least one of the five criteria: - Rising IgM - Hemoglobin <= 10 gm/dL - Platelet count <= 100 x 109/L - Symptomatic or bulky lymphadenopathy or organomegaly - Systemic manifestations of WM, including hyperviscosity, neuropathy, amyloidosis, cryoglobulinemia, B symptoms

Data type

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0024419
UMLS CUI [1,4]
C0679228
Measurable disease as defined by a monoclonal IgM paraprotein level greater than 1000 mg/dL
Description

Measurable disease, defined by a monoclonal IgM paraprotein level

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0024419
UMLS CUI [2,1]
C0585639
UMLS CUI [2,2]
C0202084
Age >= 18 years of age
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Detectable CD20 positive of the tumor cells based upon bone marrow immunohistochemistry or flow cytometric analysis.
Description

CD20 positive tumor cells based upon bone marrow immunohistochemistry or flow cytometric analysis

Data type

boolean

Alias
UMLS CUI [1,1]
C3888518
UMLS CUI [1,2]
C0597032
UMLS CUI [1,3]
C0005954
UMLS CUI [2,1]
C3888518
UMLS CUI [2,2]
C0597032
UMLS CUI [2,3]
C0016263
Eastern Cooperative Oncology Group (ECOG) performance status <= 2 at study entry and a life expectancy of greater than 6 months.
Description

ECOG performance status and life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0023671
Adequate organ function as defined by: - Absolute neutrophil count >= 1.0 x 109/L unless the result of marrow infiltration by WM, - Platelet count > 50 x 109/L - ALT and AST <= 2.5 times the institutional ULN - Total bilirubin < 2 times the institutional ULN unless the result of Gilbert's disease - Serum creatinine < 3 mg/dL
Description

Adequate organ function defined by: Absolute neutrophil count unless the result of marrow infiltration by WM, Platelet count, ALT and AST, Total bilirubin unless the result of Gilbert's disease, Serum creatinine

Data type

boolean

Alias
UMLS CUI [1,1]
C0205411
UMLS CUI [1,2]
C0678852
UMLS CUI [2]
C0948762
UMLS CUI [3,1]
C0332300
UMLS CUI [3,2]
C0948762
UMLS CUI [3,3]
C3854434
UMLS CUI [3,4]
C0024419
UMLS CUI [4]
C0032181
UMLS CUI [5]
C0201836
UMLS CUI [6]
C0201899
UMLS CUI [7]
C0201913
UMLS CUI [8,1]
C0332300
UMLS CUI [8,2]
C0201913
UMLS CUI [8,3]
C0017551
UMLS CUI [9]
C0201976
Understand and voluntarily sign informed consent.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Able to adhere to study visit schedule and other protocol requirements.
Description

protocol compliance ability

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0085732
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Treatment for WM within the past 28 days
Description

Recent treatment for WM

Data type

boolean

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0024419
Treatment with rituximab or alemtuzumab within the past 3 months
Description

recent treatment with rituximab or alemtuzumab

Data type

boolean

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C0393022
UMLS CUI [2,1]
C0332185
UMLS CUI [2,2]
C0383429
Chronic or current active infection not controlled with oral antibiotics
Description

Chronic or current active infection not controlled with oral antibiotics

Data type

boolean

Alias
UMLS CUI [1,1]
C0205177
UMLS CUI [1,2]
C0275518
UMLS CUI [1,3]
C0205318
UMLS CUI [1,4]
C0442027
UMLS CUI [1,5]
C0003232
UMLS CUI [2,1]
C0205177
UMLS CUI [2,2]
C0151317
UMLS CUI [2,3]
C0205318
UMLS CUI [2,4]
C0442027
UMLS CUI [2,5]
C0003232
Known HIV positive
Description

HIV positive

Data type

boolean

Alias
UMLS CUI [1]
C0019699
Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive and HBsAb negative, a HBDNA test will be performed and if positive the subject will be excluded. If HBcAb positive and HBsAb positive, which is indicative of a past infection, the subject can be included.
Description

positive test for HBsAg, HBcAb, HBDNA

Data type

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C0262506
UMLS CUI [3]
C3641250
Other past or current malignancy with the exception of WM. Subjects who have been free of malignancy for at least 5 years, or have a history of completely resected non-melanoma skin cancer, or successfully treated in situ carcinoma are eligible.
Description

Other past or current malignancy with the exception of WM and subjects free of malignancy, or with a history of completely resected non-melanoma skin cancer, or successfully treated in situ carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205394
UMLS CUI [2,1]
C0332300
UMLS CUI [2,2]
C0024419
UMLS CUI [3,1]
C0332300
UMLS CUI [3,2]
C0006826
UMLS CUI [3,3]
C0242793
UMLS CUI [4,1]
C0332300
UMLS CUI [4,2]
C0262926
UMLS CUI [4,3]
C0015250
UMLS CUI [4,4]
C0699893
UMLS CUI [4,5]
C1518408
UMLS CUI [5,1]
C0332300
UMLS CUI [5,2]
C1514463
UMLS CUI [5,3]
C1272703
UMLS CUI [5,4]
C0007099
Subjects suspected of not being able to comply with a study protocol
Description

Suspected unability to comply with study protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
UMLS CUI [1,3]
C0750491
Lactating women, women with a positive pregnancy test at Visit 1 or women of childbearing potential as well as men with partners of childbearing potential, who are not willing to use adequate contraception from study start through one year following last treatment dose.
Description

Adequate contraception is defined as abstinence, oral hormonal birth control, hormonal birth control injections, implants of levonorgestrel, strogenic vaginal ring, percutaneous contraceptive patches, intrauterine device, and male partner sterilization if male partner is sole partner for that subject. The double barrier method can be used in regions where considered acceptable and adequate (condom or occlusive cap plus spermicidal agent)

Data type

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2,1]
C0240802
UMLS CUI [2,2]
C3173309
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0205410
UMLS CUI [3,3]
C0700589
UMLS CUI [3,4]
C0558080
UMLS CUI [4,1]
C0682323
UMLS CUI [4,2]
C3831118
UMLS CUI [4,3]
C0205410
UMLS CUI [4,4]
C0700589
UMLS CUI [4,5]
C0558080
Clinically significant cardiac disease including unstable angina, acute myocardial infarction within 6 months prior to Visit 1, congestive heart failure, and arrhythmia requiring therapy, with the exception of extra systoles or minor conduction abnormalities
Description

Clinically significant cardiac disease including unstable angina, recent acute myocardial infarction, congestive heart failure, and arrhythmia requiring therapy, with the exception of extra systoles or minor conduction abnormalities

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C0002965
UMLS CUI [3,1]
C0332185
UMLS CUI [3,2]
C0155626
UMLS CUI [4]
C0018802
UMLS CUI [5,1]
C0003811
UMLS CUI [5,2]
C1514873
UMLS CUI [5,3]
C0087111
UMLS CUI [6]
C0541950
UMLS CUI [7,1]
C0205165
UMLS CUI [7,2]
C0232217
UMLS CUI [7,3]
C1704258
Active cerebrovascular disease
Description

Active cerebrovascular disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0007820
UMLS CUI [1,2]
C0205177
Glucocorticoid use, unless given in doses <= 100mg/day hydrocortisone (or equivalent dose of other glucocorticoid) for <7 days for exacerbations other than WM (e.g. asthma)
Description

Glucocorticoid use, unless shortly given in small doses for exacerbations other than WM

Data type

boolean

Alias
UMLS CUI [1]
C0744425
UMLS CUI [2,1]
C0332300
UMLS CUI [2,2]
C0744425
UMLS CUI [2,3]
C0445550
UMLS CUI [2,4]
C0443303
UMLS CUI [2,5]
C4086268
UMLS CUI [2,6]
C0024419
UMLS CUI [2,7]
C0332197
Previous treatment or known or suspected hypersensitivity to ofatumumab
Description

Previous treatment or known or suspected hypersensitivity to ofatumumab

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1832027
UMLS CUI [2,1]
C0750491
UMLS CUI [2,2]
C0020517
UMLS CUI [2,3]
C1832027
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C1832027
Treatment with any known non-marketed drug substance or experimental therapy within 5 terminal half lives or 4 weeks prior to Visit 1, whichever is longer or currently participating in any other interventional clinical study
Description

Recent treatment with investigational new drug or experimental therapy or currently participating in any other interventional clinical study

Data type

boolean

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0332185
UMLS CUI [2,2]
C0304229
UMLS CUI [3,1]
C0521116
UMLS CUI [3,2]
C0205394
UMLS CUI [3,3]
C2348568
Liver Disease: Current active hepatic or biliary disease (with the exception of Gilbert’s syndrome or asymptomatic gallstones, liver metastases or otherwise stable chronic liver disease per investigator assessment)
Description

Current active hepatic or biliary disease except for Gilbert’s syndrome or asymptomatic gallstones, liver metastases or otherwise stable chronic liver disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205177
UMLS CUI [2,1]
C3275124
UMLS CUI [2,2]
C0205177
UMLS CUI [3,1]
C0332300
UMLS CUI [3,2]
C0017551
UMLS CUI [4,1]
C0332300
UMLS CUI [4,2]
C3842395
UMLS CUI [4,3]
C0231221
UMLS CUI [5,1]
C0332300
UMLS CUI [5,2]
C0494165
UMLS CUI [5,3]
C0231221
UMLS CUI [6,1]
C0332300
UMLS CUI [6,2]
C0677946
UMLS CUI [6,3]
C0341439
UMLS CUI [6,4]
C0231221
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Eligibility Criteria

1 forms
  1. StudyEvent: ODM
    1. Eligibility Criteria
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
date of visit/assessment
Item
date of visit/assessment
date
C1320303 (UMLS CUI [1])
C2985720 (UMLS CUI [2])
subject ID
Item
subject number
text
C2348585 (UMLS CUI [1])
Item Group
Eligibility Question
C0013893 (UMLS CUI-1)
eligibility criteria
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Diagnosis of Waldenstrom's macroglobulinemia
Item
Diagnosis of Waldenstrom's macroglobulinemia as defined by the criteria established from the 2nd International workshop on WM
boolean
C0024419 (UMLS CUI [1,1])
C0679228 (UMLS CUI [1,2])
Requiring therapy for Waldenstrom's Macroglobulinemia
Item
Requiring therapy based upon the criteria established by the consensus panel from the 2nd International Workshop on WM.
boolean
C1514873 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0024419 (UMLS CUI [1,3])
C0679228 (UMLS CUI [1,4])
Measurable disease, defined by a monoclonal IgM paraprotein level
Item
Measurable disease as defined by a monoclonal IgM paraprotein level greater than 1000 mg/dL
boolean
C1513041 (UMLS CUI [1,1])
C0024419 (UMLS CUI [1,2])
C0585639 (UMLS CUI [2,1])
C0202084 (UMLS CUI [2,2])
age
Item
Age >= 18 years of age
boolean
C0001779 (UMLS CUI [1])
CD20 positive tumor cells based upon bone marrow immunohistochemistry or flow cytometric analysis
Item
Detectable CD20 positive of the tumor cells based upon bone marrow immunohistochemistry or flow cytometric analysis.
boolean
C3888518 (UMLS CUI [1,1])
C0597032 (UMLS CUI [1,2])
C0005954 (UMLS CUI [1,3])
C3888518 (UMLS CUI [2,1])
C0597032 (UMLS CUI [2,2])
C0016263 (UMLS CUI [2,3])
ECOG performance status and life expectancy
Item
Eastern Cooperative Oncology Group (ECOG) performance status <= 2 at study entry and a life expectancy of greater than 6 months.
boolean
C1520224 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Adequate organ function defined by: Absolute neutrophil count unless the result of marrow infiltration by WM, Platelet count, ALT and AST, Total bilirubin unless the result of Gilbert's disease, Serum creatinine
Item
Adequate organ function as defined by: - Absolute neutrophil count >= 1.0 x 109/L unless the result of marrow infiltration by WM, - Platelet count > 50 x 109/L - ALT and AST <= 2.5 times the institutional ULN - Total bilirubin < 2 times the institutional ULN unless the result of Gilbert's disease - Serum creatinine < 3 mg/dL
boolean
C0205411 (UMLS CUI [1,1])
C0678852 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0332300 (UMLS CUI [3,1])
C0948762 (UMLS CUI [3,2])
C3854434 (UMLS CUI [3,3])
C0024419 (UMLS CUI [3,4])
C0032181 (UMLS CUI [4])
C0201836 (UMLS CUI [5])
C0201899 (UMLS CUI [6])
C0201913 (UMLS CUI [7])
C0332300 (UMLS CUI [8,1])
C0201913 (UMLS CUI [8,2])
C0017551 (UMLS CUI [8,3])
C0201976 (UMLS CUI [9])
informed consent
Item
Understand and voluntarily sign informed consent.
boolean
C0021430 (UMLS CUI [1])
protocol compliance ability
Item
Able to adhere to study visit schedule and other protocol requirements.
boolean
C0525058 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Recent treatment for WM
Item
Treatment for WM within the past 28 days
boolean
C0332185 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0024419 (UMLS CUI [1,3])
recent treatment with rituximab or alemtuzumab
Item
Treatment with rituximab or alemtuzumab within the past 3 months
boolean
C0332185 (UMLS CUI [1,1])
C0393022 (UMLS CUI [1,2])
C0332185 (UMLS CUI [2,1])
C0383429 (UMLS CUI [2,2])
Chronic or current active infection not controlled with oral antibiotics
Item
Chronic or current active infection not controlled with oral antibiotics
boolean
C0205177 (UMLS CUI [1,1])
C0275518 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C0442027 (UMLS CUI [1,4])
C0003232 (UMLS CUI [1,5])
C0205177 (UMLS CUI [2,1])
C0151317 (UMLS CUI [2,2])
C0205318 (UMLS CUI [2,3])
C0442027 (UMLS CUI [2,4])
C0003232 (UMLS CUI [2,5])
HIV positive
Item
Known HIV positive
boolean
C0019699 (UMLS CUI [1])
positive test for HBsAg, HBcAb, HBDNA
Item
Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive and HBsAb negative, a HBDNA test will be performed and if positive the subject will be excluded. If HBcAb positive and HBsAb positive, which is indicative of a past infection, the subject can be included.
boolean
C0149709 (UMLS CUI [1])
C0262506 (UMLS CUI [2])
C3641250 (UMLS CUI [3])
Other past or current malignancy with the exception of WM and subjects free of malignancy, or with a history of completely resected non-melanoma skin cancer, or successfully treated in situ carcinoma
Item
Other past or current malignancy with the exception of WM. Subjects who have been free of malignancy for at least 5 years, or have a history of completely resected non-melanoma skin cancer, or successfully treated in situ carcinoma are eligible.
boolean
C0006826 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0332300 (UMLS CUI [2,1])
C0024419 (UMLS CUI [2,2])
C0332300 (UMLS CUI [3,1])
C0006826 (UMLS CUI [3,2])
C0242793 (UMLS CUI [3,3])
C0332300 (UMLS CUI [4,1])
C0262926 (UMLS CUI [4,2])
C0015250 (UMLS CUI [4,3])
C0699893 (UMLS CUI [4,4])
C1518408 (UMLS CUI [4,5])
C0332300 (UMLS CUI [5,1])
C1514463 (UMLS CUI [5,2])
C1272703 (UMLS CUI [5,3])
C0007099 (UMLS CUI [5,4])
Suspected unability to comply with study protocol
Item
Subjects suspected of not being able to comply with a study protocol
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0750491 (UMLS CUI [1,3])
Lactating women, positive pregnancy test at start of treatment, women of childbearing potential and men with partners of childbearing potential, who are not willing to use adequate contraception
Item
Lactating women, women with a positive pregnancy test at Visit 1 or women of childbearing potential as well as men with partners of childbearing potential, who are not willing to use adequate contraception from study start through one year following last treatment dose.
boolean
C0006147 (UMLS CUI [1])
C0240802 (UMLS CUI [2,1])
C3173309 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0205410 (UMLS CUI [3,2])
C0700589 (UMLS CUI [3,3])
C0558080 (UMLS CUI [3,4])
C0682323 (UMLS CUI [4,1])
C3831118 (UMLS CUI [4,2])
C0205410 (UMLS CUI [4,3])
C0700589 (UMLS CUI [4,4])
C0558080 (UMLS CUI [4,5])
Clinically significant cardiac disease including unstable angina, recent acute myocardial infarction, congestive heart failure, and arrhythmia requiring therapy, with the exception of extra systoles or minor conduction abnormalities
Item
Clinically significant cardiac disease including unstable angina, acute myocardial infarction within 6 months prior to Visit 1, congestive heart failure, and arrhythmia requiring therapy, with the exception of extra systoles or minor conduction abnormalities
boolean
C0018799 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0002965 (UMLS CUI [2])
C0332185 (UMLS CUI [3,1])
C0155626 (UMLS CUI [3,2])
C0018802 (UMLS CUI [4])
C0003811 (UMLS CUI [5,1])
C1514873 (UMLS CUI [5,2])
C0087111 (UMLS CUI [5,3])
C0541950 (UMLS CUI [6])
C0205165 (UMLS CUI [7,1])
C0232217 (UMLS CUI [7,2])
C1704258 (UMLS CUI [7,3])
Active cerebrovascular disease
Item
Active cerebrovascular disease
boolean
C0007820 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
Glucocorticoid use, unless shortly given in small doses for exacerbations other than WM
Item
Glucocorticoid use, unless given in doses <= 100mg/day hydrocortisone (or equivalent dose of other glucocorticoid) for <7 days for exacerbations other than WM (e.g. asthma)
boolean
C0744425 (UMLS CUI [1])
C0332300 (UMLS CUI [2,1])
C0744425 (UMLS CUI [2,2])
C0445550 (UMLS CUI [2,3])
C0443303 (UMLS CUI [2,4])
C4086268 (UMLS CUI [2,5])
C0024419 (UMLS CUI [2,6])
C0332197 (UMLS CUI [2,7])
Previous treatment or known or suspected hypersensitivity to ofatumumab
Item
Previous treatment or known or suspected hypersensitivity to ofatumumab
boolean
C1514463 (UMLS CUI [1,1])
C1832027 (UMLS CUI [1,2])
C0750491 (UMLS CUI [2,1])
C0020517 (UMLS CUI [2,2])
C1832027 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C1832027 (UMLS CUI [3,2])
Recent treatment with investigational new drug or experimental therapy or currently participating in any other interventional clinical study
Item
Treatment with any known non-marketed drug substance or experimental therapy within 5 terminal half lives or 4 weeks prior to Visit 1, whichever is longer or currently participating in any other interventional clinical study
boolean
C0332185 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0332185 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
C0521116 (UMLS CUI [3,1])
C0205394 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
Current active hepatic or biliary disease except for Gilbert’s syndrome or asymptomatic gallstones, liver metastases or otherwise stable chronic liver disease
Item
Liver Disease: Current active hepatic or biliary disease (with the exception of Gilbert’s syndrome or asymptomatic gallstones, liver metastases or otherwise stable chronic liver disease per investigator assessment)
boolean
C0023895 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C3275124 (UMLS CUI [2,1])
C0205177 (UMLS CUI [2,2])
C0332300 (UMLS CUI [3,1])
C0017551 (UMLS CUI [3,2])
C0332300 (UMLS CUI [4,1])
C3842395 (UMLS CUI [4,2])
C0231221 (UMLS CUI [4,3])
C0332300 (UMLS CUI [5,1])
C0494165 (UMLS CUI [5,2])
C0231221 (UMLS CUI [5,3])
C0332300 (UMLS CUI [6,1])
C0677946 (UMLS CUI [6,2])
C0341439 (UMLS CUI [6,3])
C0231221 (UMLS CUI [6,4])
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