ID

42555

Beschrijving

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. Record the details of any Adverse Events or exacerbations of Adverse Events on the Non-Serious Adverse Event Form or the Serious Adverse Event form. Exacerbations of Adverse Events include increases in frequency and severity. It is particularly important to record any gallbladder or biliary disease, or pancreatitis, that occurred during the study. This form has to be filled out whenever / if liver events occur.

Link

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

Trefwoorden

Versies (1)
  1. 30-08-21 30-08-21 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

30 augustus 2021

DOI

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Licentie

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

Engels

Liver Events

1 Formulieren  
  1. StudyEvent: ODM
    1. Liver Events
Administrative Data
Beschrijving

Administrative Data

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

date of visit/assessment

Datatype

text

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

subject ID

Datatype

text

Alias
UMLS CUI [1]
C2348585
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
Beschrijving

Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?

Alias
UMLS CUI-1
C0023901
ALT (alanine aminotransferase)
Beschrijving

Check all that apply.

Datatype

boolean

Alias
UMLS CUI [1]
C0201836
Total bilirubin
Beschrijving

Check all that apply.

Datatype

boolean

Alias
UMLS CUI [1]
C0201913
Liver events
Beschrijving

Liver events

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0877248
Is the subject age 55 or older?
Beschrijving

Subject age

Datatype

boolean

Alias
UMLS CUI [1]
C2348575
If female, is the subject pregnant?
Beschrijving

If Yes, ensure Pregnancy Notification Form has been completed.

Datatype

text

Alias
UMLS CUI [1]
C0032961
Were any diagnostic imaging tests of the liver or hepatobiliary system performed (such as a liver ultrasound, computerized tomography or CAT scan, magnetic resonance imaging or MRI, or endoscopic retrograde cholangiopancreatography, or other)?
Beschrijving

Diagnostic imaging tests of the liver or hepatobiliary system (i.e. liver ultrasound, computerized tomography or CAT scan, magnetic resonance imaging or MRI, or endoscopic retrograde cholangiopancreatography)

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0023884
UMLS CUI [2,1]
C0011923
UMLS CUI [2,2]
C1711359
UMLS CUI [3,1]
C0023884
UMLS CUI [3,2]
C1456803
UMLS CUI [4,1]
C0023884
UMLS CUI [4,2]
C0040405
UMLS CUI [5,1]
C0023884
UMLS CUI [5,2]
C0024485
UMLS CUI [6]
C0008310
If Yes, were the results normal?
Beschrijving

If No, record the details on the Non-Serious Adverse Events form or Serious Adverse Event form.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0023884
UMLS CUI [1,3]
C1274040
UMLS CUI [2,1]
C0011923
UMLS CUI [2,2]
C1711359
UMLS CUI [2,3]
C1274040
Were any liver biopsies performed?
Beschrijving

If Yes, complete Liver Biopsy form. [hidden]

Datatype

boolean

Alias
UMLS CUI [1]
C0193388
Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
Beschrijving

If Yes, record on the appropriate Concomitant Medication form.

Datatype

boolean

Alias
UMLS CUI [1]
C0002346
UMLS CUI [2]
C0242295
UMLS CUI [3]
C0281875
UMLS CUI [4]
C1360419
UMLS CUI [5]
C4053461
Did the subject fast or undergo significant dietary change in the past week?
Beschrijving

Recent fasting or dietary changes

Datatype

boolean

Alias
UMLS CUI [1,1]
C3671772
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0015663
UMLS CUI [2,2]
C0332185
Evaluation interval code
Beschrijving

[hidden]

Datatype

text

Alias
UMLS CUI [1]
C2826267
Pharmacokinetics (Liver PK)
Beschrijving

Pharmacokinetics (Liver PK)

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0031328
Was a pharmacokinetic blood sample obtained?
Beschrijving

An unscheduled blood sample for pharmacokinetic (PK) analysis of ofatumumab must be obtained as soon as possible but no later than 5 months of last dose (approximately 5 half-lives of the drug). PK sample should only be taken if subject is currently on ofatumumab.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0031328
If yes, date and time sample taken
Beschrijving

An unscheduled blood sample for pharmacokinetic (PK) analysis of ofatumumab must be obtained as soon as possible but no later than 5 months of last dose (approximately 5 half-lives of the drug). PK sample should only be taken if subject is currently on ofatumumab.

Datatype

datetime

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0031328
UMLS CUI [1,3]
C0011008
UMLS CUI [2,1]
C0005834
UMLS CUI [2,2]
C0031328
UMLS CUI [2,3]
C0040223
If yes, date and time of last investigational product dose prior to PK sample
Beschrijving

An unscheduled blood sample for pharmacokinetic (PK) analysis of ofatumumab must be obtained as soon as possible but no later than 5 months of last dose (approximately 5 half-lives of the drug). PK sample should only be taken if subject is currently on ofatumumab.

Datatype

datetime

Alias
UMLS CUI [1,1]
C1517741
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0011008
UMLS CUI [2,1]
C1517741
UMLS CUI [2,2]
C0304229
UMLS CUI [2,3]
C0040223
Investigational product (Liver)
Beschrijving

Investigational product (Liver)

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0023884
Start Date Investigational Product not applicable
Beschrijving

Note: Only complete dates for the treatment period where the liver event occurred. If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period.

Datatype

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C2347804
UMLS CUI [1,4]
C0304229
UMLS CUI [1,5]
C0808070
UMLS CUI [1,6]
C1272460
Start Date Investigational Product
Beschrijving

Note: Only complete dates for the treatment period where the liver event occurred. If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period.

Datatype

partialDate

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C2347804
UMLS CUI [1,4]
C0304229
UMLS CUI [1,5]
C0808070
End/Interruption Date Investigational Product not applicable
Beschrijving

Note: Only complete dates for the treatment period where the liver event occurred. If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period.

Datatype

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C2347804
UMLS CUI [1,4]
C0304229
UMLS CUI [1,5]
C0806020
UMLS CUI [1,6]
C1272460
UMLS CUI [2,1]
C0877248
UMLS CUI [2,2]
C0347984
UMLS CUI [2,3]
C2347804
UMLS CUI [2,4]
C1512900
UMLS CUI [2,5]
C0304229
UMLS CUI [2,6]
C0806020
UMLS CUI [2,7]
C1272460
End/Interruption Date Investigational Product
Beschrijving

Note: Only complete dates for the treatment period where the liver event occurred. If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period.

Datatype

partialDate

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C2347804
UMLS CUI [1,4]
C0304229
UMLS CUI [1,5]
C0806020
UMLS CUI [2,1]
C0877248
UMLS CUI [2,2]
C0347984
UMLS CUI [2,3]
C2347804
UMLS CUI [2,4]
C1512900
UMLS CUI [2,5]
C0806020
UMLS CUI [2,6]
C0304229
Start Date Investigational Product not applicable
Beschrijving

If the liver event occurred after treatment period record start and stop date of investigational product for the most recent period prior to the liver event.

Datatype

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C0087111
UMLS CUI [1,4]
C0304229
UMLS CUI [1,5]
C0808070
UMLS CUI [1,6]
C1272460
Start Date Investigational Product
Beschrijving

If the liver event occurred after treatment period record start and stop date of investigational product for the most recent period prior to the liver event.

Datatype

partialDate

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C0087111
UMLS CUI [1,4]
C0304229
UMLS CUI [1,5]
C0808070
End/Interruption Date Investigational Product not applicable
Beschrijving

If the liver event occurred after treatment period record start and stop date of investigational product for the most recent period prior to the liver event.

Datatype

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C0087111
UMLS CUI [1,4]
C0304229
UMLS CUI [1,5]
C0806020
UMLS CUI [1,6]
C1272460
UMLS CUI [2,1]
C0877248
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C0087111
UMLS CUI [2,4]
C1512900
UMLS CUI [2,5]
C0304229
UMLS CUI [2,6]
C0806020
UMLS CUI [2,7]
C1272460
End/Interruption Date Investigational Product
Beschrijving

If the liver event occurred after treatment period record start and stop date of investigational product for the most recent period prior to the liver event.

Datatype

partialDate

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C0087111
UMLS CUI [1,4]
C0304229
UMLS CUI [1,5]
C0806020
UMLS CUI [2,1]
C0877248
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C0087111
UMLS CUI [2,4]
C1512900
UMLS CUI [2,5]
C0304229
UMLS CUI [2,6]
C0806020
Liver disease medical conditions
Beschrijving

Liver disease medical conditions

Alias
UMLS CUI-1
C0023895
Acute Viral Hepatitis A
Beschrijving

Acute Viral Hepatitis A

Datatype

text

Alias
UMLS CUI [1]
C0276434
Chronic Hepatitis B
Beschrijving

Chronic Hepatitis B

Datatype

text

Alias
UMLS CUI [1]
C0524909
Chronic Hepatitis C
Beschrijving

Chronic Hepatitis C

Datatype

text

Alias
UMLS CUI [1]
C0524910
Cytomegalovirus Hepatitis
Beschrijving

Cytomegalovirus Hepatitis

Datatype

text

Alias
UMLS CUI [1]
C0276252
Epstein Barr Virus Infectious Mononucleosis
Beschrijving

Epstein Barr Virus Infectious Mononucleosis

Datatype

text

Alias
UMLS CUI [1,1]
C0021345
UMLS CUI [1,2]
C0014644
Herpes Simplex Hepatitis
Beschrijving

Herpes Simplex Hepatitis

Datatype

text

Alias
UMLS CUI [1]
C1963747
Alcoholic Liver Disease
Beschrijving

Alcoholic Liver Disease

Datatype

text

Alias
UMLS CUI [1]
C0023896
Non-alcoholic Steatohepatitis
Beschrijving

Non-alcoholic Steatohepatitis

Datatype

text

Alias
UMLS CUI [1]
C3241937
Fatty Liver
Beschrijving

Fatty Liver

Datatype

text

Alias
UMLS CUI [1]
C0015695
Hepatic Cirrhosis
Beschrijving

Hepatic Cirrhosis

Datatype

text

Alias
UMLS CUI [1]
C0023890
Hemochromatosis
Beschrijving

Hemochromatosis

Datatype

text

Alias
UMLS CUI [1]
C0018995
Autoimmune Hepatitis
Beschrijving

Autoimmune Hepatitis

Datatype

text

Alias
UMLS CUI [1]
C0241910
Gallbladder disease
Beschrijving

Gallbladder disease

Datatype

text

Alias
UMLS CUI [1]
C0016977
Liver metastases
Beschrijving

Liver metastases

Datatype

text

Alias
UMLS CUI [1]
C0494165
Hepatitis E IgM antibody
Beschrijving

Hepatitis E IgM antibody

Datatype

text

Alias
UMLS CUI [1]
C3272944
Drug related liver disease conditions
Beschrijving

Drug related liver disease conditions

Alias
UMLS CUI-1
C0023895
UMLS CUI-2
C0277579
Drug related liver disease
Beschrijving

(All drugs including Investigational Product)

Datatype

text

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0277579
Other liver disease conditions Entry
Beschrijving

Other liver disease conditions Entry

Alias
UMLS CUI-1
C0023895
UMLS CUI-2
C0205394
Sequence Number
Beschrijving

[hidden]

Datatype

text

Alias
UMLS CUI [1]
C2348184
Specific condition
Beschrijving

Specific condition

Datatype

text

Alias
UMLS CUI [1]
C0023895
Modified Term
Beschrijving

[hidden]

Datatype

text

Alias
UMLS CUI [1,1]
C2826923
UMLS CUI [1,2]
C0023895
MedDRA Synonym
Beschrijving

[hidden]

Datatype

text

Alias
UMLS CUI [1]
C1140263
MedDRA lower level term code
Beschrijving

[hidden]

Datatype

text

Alias
UMLS CUI [1]
C3898442
Failed coding
Beschrijving

[hidden]

Datatype

text

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C0231175
Status
Beschrijving

Liver disease, Status

Datatype

text

Alias
UMLS CUI [1,1]
C0449438
UMLS CUI [1,2]
C0023895
Other medical conditions
Beschrijving

Other medical conditions

Alias
UMLS CUI-1
C0012634
UMLS CUI-2
C0205394
Drug allergies
Beschrijving

Drug allergies

Datatype

text

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013227
Rheumatoid Arthritis
Beschrijving

Rheumatoid Arthritis

Datatype

text

Alias
UMLS CUI [1]
C0003873
Psoriasis
Beschrijving

Psoriasis

Datatype

text

Alias
UMLS CUI [1]
C0033860
Thyroid Disease
Beschrijving

Thyroid Disease

Datatype

text

Alias
UMLS CUI [1]
C0040128
Inflammatory Bowel Disease
Beschrijving

Inflammatory Bowel Disease

Datatype

text

Alias
UMLS CUI [1]
C0021390
Lupus
Beschrijving

Lupus

Datatype

text

Alias
UMLS CUI [1]
C0409974
Sjogrens Syndrome
Beschrijving

Sjogrens Syndrome

Datatype

text

Alias
UMLS CUI [1]
C1527336
Vitiligo
Beschrijving

Vitiligo

Datatype

text

Alias
UMLS CUI [1]
C0042900
Alcohol intake (Liver alcohol)
Beschrijving

Alcohol intake (Liver alcohol)

Alias
UMLS CUI-1
C0001948
Does the subject consume alcohol?
Beschrijving

Alcohol consumption

Datatype

boolean

Alias
UMLS CUI [1]
C0001948
If yes, record the average number of units of alcohol consumed per week
Beschrijving

Average number of units per week

Datatype

integer

Maateenheden
  • units of alcohol per week
Alias
UMLS CUI [1,1]
C0560579
UMLS CUI [1,2]
C1510992
units of alcohol per week
Substance Use Type
Beschrijving

[hidden]

Datatype

text

Alias
UMLS CUI [1,1]
C0439861
UMLS CUI [1,2]
C1524063
UMLS CUI [1,3]
C0332307
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Similar models

Liver Events

1 Formulieren
  1. StudyEvent: ODM
    1. Liver Events
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
date of visit/assessment
Item
date of visit/assessment
text
C1320303 (UMLS CUI [1])
C2985720 (UMLS CUI [2])
subject ID
Item
subject number
text
C2348585 (UMLS CUI [1])
Item Group
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
C0023901 (UMLS CUI-1)
ALT (alanine aminotransferase)
Item
ALT (alanine aminotransferase)
boolean
C0201836 (UMLS CUI [1])
Total bilirubin
Item
Total bilirubin
boolean
C0201913 (UMLS CUI [1])
Item Group
Liver events
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
Subject age
Item
Is the subject age 55 or older?
boolean
C2348575 (UMLS CUI [1])
Item
If female, is the subject pregnant?
text
C0032961 (UMLS CUI [1])
If female, is the subject pregnant?
Code List
If female, is the subject pregnant?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not applicable (X)
Diagnostic imaging tests of the liver or hepatobiliary system (i.e. liver ultrasound, computerized tomography or CAT scan, magnetic resonance imaging or MRI, or endoscopic retrograde cholangiopancreatography)
Item
Were any diagnostic imaging tests of the liver or hepatobiliary system performed (such as a liver ultrasound, computerized tomography or CAT scan, magnetic resonance imaging or MRI, or endoscopic retrograde cholangiopancreatography, or other)?
boolean
C0011923 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0011923 (UMLS CUI [2,1])
C1711359 (UMLS CUI [2,2])
C0023884 (UMLS CUI [3,1])
C1456803 (UMLS CUI [3,2])
C0023884 (UMLS CUI [4,1])
C0040405 (UMLS CUI [4,2])
C0023884 (UMLS CUI [5,1])
C0024485 (UMLS CUI [5,2])
C0008310 (UMLS CUI [6])
Diagnostic imaging tests of the liver or hepatobiliary system, results
Item
If Yes, were the results normal?
boolean
C0011923 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C0011923 (UMLS CUI [2,1])
C1711359 (UMLS CUI [2,2])
C1274040 (UMLS CUI [2,3])
Liver biopsies
Item
Were any liver biopsies performed?
boolean
C0193388 (UMLS CUI [1])
Usage of Herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs
Item
Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
boolean
C0002346 (UMLS CUI [1])
C0242295 (UMLS CUI [2])
C0281875 (UMLS CUI [3])
C1360419 (UMLS CUI [4])
C4053461 (UMLS CUI [5])
Recent fasting or dietary changes
Item
Did the subject fast or undergo significant dietary change in the past week?
boolean
C3671772 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0015663 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
Evaluation interval
Item
Evaluation interval code
text
C2826267 (UMLS CUI [1])
Item Group
Pharmacokinetics (Liver PK)
C0023884 (UMLS CUI-1)
C0031328 (UMLS CUI-2)
Pharmacokinetic blood sample
Item
Was a pharmacokinetic blood sample obtained?
boolean
C0005834 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
Pharmacokinetic blood sample, date and time
Item
If yes, date and time sample taken
datetime
C0005834 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0005834 (UMLS CUI [2,1])
C0031328 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
Pharmacokinetic blood sample, date and time of last investigational product
Item
If yes, date and time of last investigational product dose prior to PK sample
datetime
C1517741 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1517741 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
Item Group
Investigational product (Liver)
C0304229 (UMLS CUI-1)
C0023884 (UMLS CUI-2)
Item
Start Date Investigational Product not applicable
text
C0877248 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C0808070 (UMLS CUI [1,5])
C1272460 (UMLS CUI [1,6])
Adverse event during treatment, Start Date Investigational Product, not applicable
Code List
Start Date Investigational Product not applicable
CL Item
Date applicable  (99)
CL Item
Not applicable (98)
Adverse event during treatment, Start Date Investigational Product
Item
Start Date Investigational Product
partialDate
C0877248 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C0808070 (UMLS CUI [1,5])
Item
End/Interruption Date Investigational Product not applicable
text
C0877248 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C0806020 (UMLS CUI [1,5])
C1272460 (UMLS CUI [1,6])
C0877248 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
C2347804 (UMLS CUI [2,3])
C1512900 (UMLS CUI [2,4])
C0304229 (UMLS CUI [2,5])
C0806020 (UMLS CUI [2,6])
C1272460 (UMLS CUI [2,7])
Adverse event during treatment, Start Date Investigational Product, not applicable
Code List
End/Interruption Date Investigational Product not applicable
CL Item
Date applicable  (99)
CL Item
Not applicable (98)
Adverse event during treatment, End/Interruption Date Investigational Product
Item
End/Interruption Date Investigational Product
partialDate
C0877248 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C0806020 (UMLS CUI [1,5])
C0877248 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
C2347804 (UMLS CUI [2,3])
C1512900 (UMLS CUI [2,4])
C0806020 (UMLS CUI [2,5])
C0304229 (UMLS CUI [2,6])
Item
Start Date Investigational Product not applicable
text
C0877248 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C0808070 (UMLS CUI [1,5])
C1272460 (UMLS CUI [1,6])
Adverse event during treatment, Start Date Investigational Product, not applicable
Code List
Start Date Investigational Product not applicable
CL Item
Date applicable  (99)
CL Item
Not applicable (98)
Adverse event after treatment, start Date Investigational Product
Item
Start Date Investigational Product
partialDate
C0877248 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C0808070 (UMLS CUI [1,5])
Item
End/Interruption Date Investigational Product not applicable
text
C0877248 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C0806020 (UMLS CUI [1,5])
C1272460 (UMLS CUI [1,6])
C0877248 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C1512900 (UMLS CUI [2,4])
C0304229 (UMLS CUI [2,5])
C0806020 (UMLS CUI [2,6])
C1272460 (UMLS CUI [2,7])
Adverse event during treatment, Start Date Investigational Product, not applicable
Code List
End/Interruption Date Investigational Product not applicable
CL Item
Date applicable  (99)
CL Item
Not applicable (98)
Adverse event after treatment, End/Interruption Date Investigational Product
Item
End/Interruption Date Investigational Product
partialDate
C0877248 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C0806020 (UMLS CUI [1,5])
C0877248 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C1512900 (UMLS CUI [2,4])
C0304229 (UMLS CUI [2,5])
C0806020 (UMLS CUI [2,6])
Item Group
Liver disease medical conditions
C0023895 (UMLS CUI-1)
Item
Acute Viral Hepatitis A
text
C0276434 (UMLS CUI [1])
undefined item
Code List
Acute Viral Hepatitis A
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Chronic Hepatitis B
text
C0524909 (UMLS CUI [1])
undefined item
Code List
Chronic Hepatitis B
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Chronic Hepatitis C
text
C0524910 (UMLS CUI [1])
undefined item
Code List
Chronic Hepatitis C
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Cytomegalovirus Hepatitis
text
C0276252 (UMLS CUI [1])
undefined item
Code List
Cytomegalovirus Hepatitis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Epstein Barr Virus Infectious Mononucleosis
text
C0021345 (UMLS CUI [1,1])
C0014644 (UMLS CUI [1,2])
undefined item
Code List
Epstein Barr Virus Infectious Mononucleosis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Herpes Simplex Hepatitis
text
C1963747 (UMLS CUI [1])
undefined item
Code List
Herpes Simplex Hepatitis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Alcoholic Liver Disease
text
C0023896 (UMLS CUI [1])
undefined item
Code List
Alcoholic Liver Disease
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Non-alcoholic Steatohepatitis
text
C3241937 (UMLS CUI [1])
undefined item
Code List
Non-alcoholic Steatohepatitis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Fatty Liver
text
C0015695 (UMLS CUI [1])
undefined item
Code List
Fatty Liver
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Hepatic Cirrhosis
text
C0023890 (UMLS CUI [1])
undefined item
Code List
Hepatic Cirrhosis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Hemochromatosis
text
C0018995 (UMLS CUI [1])
undefined item
Code List
Hemochromatosis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Autoimmune Hepatitis
text
C0241910 (UMLS CUI [1])
undefined item
Code List
Autoimmune Hepatitis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Gallbladder disease
text
C0016977 (UMLS CUI [1])
undefined item
Code List
Gallbladder disease
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Liver metastases
text
C0494165 (UMLS CUI [1])
undefined item
Code List
Liver metastases
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Hepatitis E IgM antibody
text
C3272944 (UMLS CUI [1])
undefined item
Code List
Hepatitis E IgM antibody
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item Group
Drug related liver disease conditions
C0023895 (UMLS CUI-1)
C0277579 (UMLS CUI-2)
Item
Drug related liver disease
text
C0023895 (UMLS CUI [1,1])
C0277579 (UMLS CUI [1,2])
Drug related liver disease
Code List
Drug related liver disease
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item Group
Other liver disease conditions Entry
C0023895 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
Sequence Number
Item
Sequence Number
text
C2348184 (UMLS CUI [1])
Specific condition
Item
Specific condition
text
C0023895 (UMLS CUI [1])
Modified Term
Item
Modified Term
text
C2826923 (UMLS CUI [1,1])
C0023895 (UMLS CUI [1,2])
MedDRA Synonym
Item
MedDRA Synonym
text
C1140263 (UMLS CUI [1])
MedDRA lower level term code
Item
MedDRA lower level term code
text
C3898442 (UMLS CUI [1])
Failed coding
Item
Failed coding
text
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Item
Status
text
C0449438 (UMLS CUI [1,1])
C0023895 (UMLS CUI [1,2])
Liver disease, Status
Code List
Status
CL Item
Current (1)
CL Item
Past (2)
Item Group
Other medical conditions
C0012634 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
Item
Drug allergies
text
C0020517 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
undefined item
Code List
Drug allergies
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Rheumatoid Arthritis
text
C0003873 (UMLS CUI [1])
undefined item
Code List
Rheumatoid Arthritis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Psoriasis
text
C0033860 (UMLS CUI [1])
undefined item
Code List
Psoriasis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Thyroid Disease
text
C0040128 (UMLS CUI [1])
undefined item
Code List
Thyroid Disease
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Inflammatory Bowel Disease
text
C0021390 (UMLS CUI [1])
undefined item
Code List
Inflammatory Bowel Disease
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Lupus
text
C0409974 (UMLS CUI [1])
undefined item
Code List
Lupus
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Sjogrens Syndrome
text
C1527336 (UMLS CUI [1])
undefined item
Code List
Sjogrens Syndrome
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Vitiligo
text
C0042900 (UMLS CUI [1])
undefined item
Code List
Vitiligo
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item Group
Alcohol intake (Liver alcohol)
C0001948 (UMLS CUI-1)
Alcohol consumption
Item
Does the subject consume alcohol?
boolean
C0001948 (UMLS CUI [1])
Average number of units per week
Item
If yes, record the average number of units of alcohol consumed per week
integer
C0560579 (UMLS CUI [1,1])
C1510992 (UMLS CUI [1,2])
Substance Use Type
Item
Substance Use Type
text
C0439861 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
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