ID

40308

Description

Study ID: 110635 Clinical Study ID: 110635 Study Title: A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy (FINAL ANALYSIS: follow-up period and cumulative safety data across the whole study) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00611455 Sponsor: GlaxoSmithKline Phase: Phase 3 Study Recruitment Status: Completed Generic Name: ofatumumab, Placebo Study Indication: Arthritis, Rheumatoid

Keywords

Versions (1)
  1. 4/2/20 4/2/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

April 2, 2020

DOI

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License

Creative Commons BY-NC 4.0
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Efficacy of ofatumumab in adult patients with active rheumatoid arthritis with inadequate response to methotrexate NCT00611455

English

Vital Signs prior to Infusion; Liver Events; Investigational Product (Liver); Pharmacokinetics (Liver); Alcohol Intake; Medical Conditions (Liver)

1 forms  
Vital Signs - Prior to Infusion
Description

Vital Signs - Prior to Infusion

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0574032
UMLS CUI-3
C0332152
Actual date/time
Description

Actual date/time

Data type

datetime

Alias
UMLS CUI [1]
C1264639
Weight
Description

Weight

Data type

integer

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Systolic Blood Pressure
Description

Systolic Blood Pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic Blood Pressure
Description

Diastolic Blood Pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Subject position
Description

(Position should be consistent throughout the study)

Data type

integer

Alias
UMLS CUI [1,1]
C1262869
UMLS CUI [1,2]
C0518766
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Temperature
Description

Temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Location of temperature
Description

(Location should be consistent throughout the study)

Data type

integer

Alias
UMLS CUI [1,1]
C2826699
UMLS CUI [1,2]
C0039476
Liver Events
Description

Liver Events

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0877248
Liver Events - Date of assessment
Description

Liver Events - Date of assessment

Data type

date

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C2985720
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
Description

Check all that apply

Data type

text

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0587081
UMLS CUI [1,4]
C0304229
UMLS CUI [1,5]
C2746065
UMLS CUI [1,6]
C0243161
Is the subject age 55 or older?
Description

Is the subject age 55 or older?

Data type

boolean

Alias
UMLS CUI [1]
C0001779
If female, is the subject pregnant?
Description

If yes, ensure Pregnancy Notification Form has been completed.

Data type

text

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

Were any diagnostic imaging tests of the liver or hepatobiliary system performed

Data type

boolean

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C1711359
UMLS CUI [1,3]
C0023884
UMLS CUI [2]
C1456803
UMLS CUI [3]
C0040405
UMLS CUI [4]
C0436427
UMLS CUI [5]
C0024485
UMLS CUI [6]
C0008310
If any diagnostic imaging tests of the liver or hepatobiliary system were performed, were the results normal?
Description

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

Data type

boolean

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

If yes, complete Liver Biopsy form.

Data type

boolean

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

If yes, record on the appropriate Concomitant Medication form.

Data type

boolean

Alias
UMLS CUI [1]
C2240391
UMLS CUI [2]
C1148474
UMLS CUI [3]
C0002346
UMLS CUI [4]
C0242295
UMLS CUI [5]
C0281875
Did the subject fast or undergo significant dietary change in the past week?
Description

Did the subject fast or undergo significant dietary change in the past week?

Data type

boolean

Alias
UMLS CUI [1]
C0015663
UMLS CUI [2]
C3671772
Investigational Product (Liver)
Description

Investigational Product (Liver)

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0023884
Start Date Investigational Product - During treatment period
Description

If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period.

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0808070
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1948053
UMLS CUI [2,3]
C0347984
Start Date Investigational Product - During treatment period
Description

Start Date Investigational Product - During treatment period

Data type

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0808070
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1948053
UMLS CUI [2,3]
C0347984
Stop Date Investigational Product - During treatment period
Description

If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period.

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0806020
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1948053
UMLS CUI [2,3]
C0347984
Stop Date Investigational Product - During treatment period
Description

Stop Date Investigational Product - During treatment period

Data type

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0806020
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1948053
UMLS CUI [2,3]
C0347984
Start Date Investigational Product - After treatment period
Description

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.

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0808070
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1948053
UMLS CUI [2,3]
C0687676
Start Date Investigational Product - After treatment period
Description

Start Date Investigational Product - After treatment period

Data type

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0808070
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1948053
UMLS CUI [2,3]
C0687676
Stop Date Investigational Product - After treatment period
Description

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.

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0806020
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1948053
UMLS CUI [2,3]
C0687676
Stop Date Investigational Product - After treatment period
Description

Stop Date Investigational Product - After treatment period

Data type

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0806020
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1948053
UMLS CUI [2,3]
C0687676
Pharmacokinetics (Liver)
Description

Pharmacokinetics (Liver)

Alias
UMLS CUI-1
C0031327
UMLS CUI-2
C0023884
Was a pharmacokinetic blood sample obtained?
Description

Was a pharmacokinetic blood sample obtained?

Data type

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0031328
Date and time sample taken
Description

Date and time sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0200345
UMLS CUI [2,1]
C0040223
UMLS CUI [2,2]
C0200345
Date and time of last investigational product dose prior to PK sample
Description

Date and time of last investigational product dose prior to PK sample

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1762893
UMLS CUI [2,1]
C0304229
UMLS CUI [2,2]
C0946444
UMLS CUI [3,1]
C1277698
UMLS CUI [3,2]
C0031327
UMLS CUI [3,3]
C0332152
Sample Identifier/Sample Number
Description

Sample Identifier/Sample Number

Data type

text

Alias
UMLS CUI [1]
C1299222
Alcohol intake
Description

Alcohol intake

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

Does the subject consume alcohol?

Data type

boolean

Alias
UMLS CUI [1]
C0001948
Record the average number of units of alcohol consumed per week
Description

Record the average number of units of alcohol consumed per week

Data type

float

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0560579
Substance Use Type
Description

Substance Use Type

Data type

text

Alias
UMLS CUI [1,1]
C0439861
UMLS CUI [1,2]
C1524063
UMLS CUI [1,3]
C0332307
Medical Conditions (Liver)
Description

Medical Conditions (Liver)

Alias
UMLS CUI-1
C0012634
UMLS CUI-2
C0023884
Medical Condition
Description

Medical Condition

Data type

integer

Alias
UMLS CUI [1]
C0012634
Condition Status
Description

Condition Status

Data type

integer

Alias
UMLS CUI [1]
C3176928
Drug related liver disease conditions
Description

Drug related liver disease conditions

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

Drug related liver disease status

Data type

integer

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0277579
UMLS CUI [1,3]
C0449438
Other Liver disease conditions
Description

Other Liver disease conditions

Alias
UMLS CUI-1
C0023895
UMLS CUI-2
C0205394
Other Liver disease conditions - Sequence Number
Description

Other Liver disease conditions - Sequence Number

Data type

integer

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205394
UMLS CUI [2]
C2348184
Other Liver disease conditions - Specific Condition
Description

Other Liver disease conditions - Specific Condition

Data type

text

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Other Liver disease conditions - Modified Term
Description

Other Liver disease conditions - Modified Term

Data type

text

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2826302
Other Liver disease conditions - MedDRA Synonym
Description

Other Liver disease conditions - MedDRA Synonym

Data type

text

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C1140263
Other Liver disease conditions - MedDRA lower level term code
Description

Other Liver disease conditions - MedDRA lower level term code

Data type

text

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C3898442
Other Liver disease conditions - Failed coding
Description

Other Liver disease conditions - Failed coding

Data type

text

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0805701
UMLS CUI [1,4]
C0231175
Other Liver disease conditions - Status
Description

Other Liver disease conditions - Status

Data type

integer

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0449438
Other medical conditions
Description

Other medical conditions

Alias
UMLS CUI-1
C0012634
UMLS CUI-2
C0205394
Other medical condition
Description

Other medical condition

Data type

integer

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205394
Other medical condition
Description

Other medical condition

Data type

integer

Alias
UMLS CUI [1,1]
C3176928
UMLS CUI [1,2]
C0205394
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Similar models

Vital Signs prior to Infusion; Liver Events; Investigational Product (Liver); Pharmacokinetics (Liver); Alcohol Intake; Medical Conditions (Liver)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Vital Signs - Prior to Infusion
C0518766 (UMLS CUI-1)
C0574032 (UMLS CUI-2)
C0332152 (UMLS CUI-3)
Actual date/time
Item
Actual date/time
datetime
C1264639 (UMLS CUI [1])
Weight
Item
Weight
integer
C0005910 (UMLS CUI [1])
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1])
Item
Subject position
integer
C1262869 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
Subject position
Code List
Subject position
CL Item
Supine (1)
CL Item
Sitting (2)
CL Item
Standing (3)
CL Item
Semi-supine (4)
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Item
Location of temperature
integer
C2826699 (UMLS CUI [1,1])
C0039476 (UMLS CUI [1,2])
Location of temperature
Code List
Location of temperature
CL Item
Oral (1)
CL Item
Rectal (2)
CL Item
Axilla (3)
CL Item
Tympanic (4)
CL Item
Intra-arterial (5)
Item Group
Liver Events
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
Liver Events - Date of assessment
Item
Liver Events - Date of assessment
date
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C2985720 (UMLS CUI [1,3])
Item
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
text
C0232741 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C2746065 (UMLS CUI [1,5])
C0243161 (UMLS CUI [1,6])
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
Code List
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
CL Item
ALT (alanine aminotransferase) (1)
CL Item
AST (aspartate aminotransferase) (2)
CL Item
Total bilirubin (3)
CL Item
Alkaline phosphatase (4)
CL Item
5` nucleotidase (5)
CL Item
Gammaglutamyltranspeptidase (6)
CL Item
Other (OT)
Is the subject age 55 or older?
Item
Is the subject age 55 or older?
boolean
C0001779 (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)
Were any diagnostic imaging tests of the liver or hepatobiliary system performed
Item
Were any diagnostic imaging tests of the liver or hepatobiliary system performed (such as liver ultrasound, computerised tomography or CAT scan, magnetic resonance imaging or MRI, or endoscopic retrograde cholangiopancreatography, or other)?
boolean
C0011923 (UMLS CUI [1,1])
C1711359 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
C1456803 (UMLS CUI [2])
C0040405 (UMLS CUI [3])
C0436427 (UMLS CUI [4])
C0024485 (UMLS CUI [5])
C0008310 (UMLS CUI [6])
If any diagnostic imaging tests of the liver or hepatobiliary system were performed, were the results normal?
Item
If any diagnostic imaging tests of the liver or hepatobiliary system were performed, were the results normal?
boolean
C0011923 (UMLS CUI [1,1])
C1711359 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
C1274040 (UMLS CUI [2,1])
C0011923 (UMLS CUI [2,2])
Were any liver biopsies performed?
Item
Were any liver biopsies performed?
boolean
C0193388 (UMLS CUI [1])
Does the subject use 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
C2240391 (UMLS CUI [1])
C1148474 (UMLS CUI [2])
C0002346 (UMLS CUI [3])
C0242295 (UMLS CUI [4])
C0281875 (UMLS CUI [5])
Did the subject fast or undergo significant dietary change in the past week?
Item
Did the subject fast or undergo significant dietary change in the past week?
boolean
C0015663 (UMLS CUI [1])
C3671772 (UMLS CUI [2])
Item Group
Investigational Product (Liver)
C0304229 (UMLS CUI-1)
C0023884 (UMLS CUI-2)
Start Date Investigational Product - During treatment period
Item
Start Date Investigational Product - During treatment period
date
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1948053 (UMLS CUI [2,2])
C0347984 (UMLS CUI [2,3])
Item
Start Date Investigational Product - During treatment period
integer
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1948053 (UMLS CUI [2,2])
C0347984 (UMLS CUI [2,3])
Start Date Investigational Product - During treatment period
Code List
Start Date Investigational Product - During treatment period
CL Item
Not applicable (98)
Stop Date Investigational Product - During treatment period
Item
Stop Date Investigational Product - During treatment period
date
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1948053 (UMLS CUI [2,2])
C0347984 (UMLS CUI [2,3])
Item
Stop Date Investigational Product - During treatment period
integer
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1948053 (UMLS CUI [2,2])
C0347984 (UMLS CUI [2,3])
Stop Date Investigational Product - During treatment period
Code List
Stop Date Investigational Product - During treatment period
CL Item
Not applicable (98)
Start Date Investigational Product - After treatment period
Item
Start Date Investigational Product - After treatment period
date
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1948053 (UMLS CUI [2,2])
C0687676 (UMLS CUI [2,3])
Item
Start Date Investigational Product - After treatment period
integer
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1948053 (UMLS CUI [2,2])
C0687676 (UMLS CUI [2,3])
Start Date Investigational Product - After treatment period
Code List
Start Date Investigational Product - After treatment period
CL Item
Not applicable (98)
Stop Date Investigational Product - After treatment period
Item
Stop Date Investigational Product - After treatment period
date
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1948053 (UMLS CUI [2,2])
C0687676 (UMLS CUI [2,3])
Item
Stop Date Investigational Product - After treatment period
integer
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1948053 (UMLS CUI [2,2])
C0687676 (UMLS CUI [2,3])
Stop Date Investigational Product - After treatment period
Code List
Stop Date Investigational Product - After treatment period
CL Item
Not applicable (98)
Item Group
Pharmacokinetics (Liver)
C0031327 (UMLS CUI-1)
C0023884 (UMLS CUI-2)
Was a pharmacokinetic blood sample obtained?
Item
Was a pharmacokinetic blood sample obtained?
boolean
C0005834 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
Date and time sample taken
Item
Date and time sample taken
datetime
C0011008 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0040223 (UMLS CUI [2,1])
C0200345 (UMLS CUI [2,2])
Date and time of last investigational product dose prior to PK sample
Item
Date and time of last investigational product dose prior to PK sample
datetime
C0304229 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2,1])
C0946444 (UMLS CUI [2,2])
C1277698 (UMLS CUI [3,1])
C0031327 (UMLS CUI [3,2])
C0332152 (UMLS CUI [3,3])
Sample Identifier/Sample Number
Item
Sample Identifier/Sample Number
text
C1299222 (UMLS CUI [1])
Item Group
Alcohol intake
C0001948 (UMLS CUI-1)
Does the subject consume alcohol?
Item
Does the subject consume alcohol?
boolean
C0001948 (UMLS CUI [1])
Record the average number of units of alcohol consumed per week
Item
Record the average number of units of alcohol consumed per week
float
C0001948 (UMLS CUI [1,1])
C0560579 (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])
Item Group
Medical Conditions (Liver)
C0012634 (UMLS CUI-1)
C0023884 (UMLS CUI-2)
Item
Medical Condition
integer
C0012634 (UMLS CUI [1])
Medical Condition
Code List
Medical Condition
CL Item
Acute Viral Hepatitis A (1)
CL Item
Chronic Hepatitis B (2)
CL Item
Chronic Hepatitis C (3)
CL Item
Cytomegalovirus Hepatitis (4)
CL Item
Epstein Barr Virus Infectious Mononucleosis (5)
CL Item
Herpes Simplex Hepatitis (6)
CL Item
Alcoholic Liver Disease (7)
CL Item
Non-alcoholic Steatohepatitis (8)
CL Item
Fatty Liver (9)
CL Item
Hepatic Cirrhosis (10)
CL Item
Hemochromatosis (11)
CL Item
Autoimmune Hepatitis (12)
CL Item
Gallbladder disease (13)
Item
Condition Status
integer
C3176928 (UMLS CUI [1])
Condition Status
Code List
Condition Status
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 status
integer
C0023895 (UMLS CUI [1,1])
C0277579 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
Drug related liver disease status
Code List
Drug related liver disease status
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item Group
Other Liver disease conditions
C0023895 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
Other Liver disease conditions - Sequence Number
Item
Other Liver disease conditions - Sequence Number
integer
C0023895 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348184 (UMLS CUI [2])
Other Liver disease conditions - Specific Condition
Item
Other Liver disease conditions - Specific Condition
text
C0023895 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Other Liver disease conditions - Modified Term
Item
Other Liver disease conditions - Modified Term
text
C0023895 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2826302 (UMLS CUI [1,3])
Other Liver disease conditions - MedDRA Synonym
Item
Other Liver disease conditions - MedDRA Synonym
text
C0023895 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1140263 (UMLS CUI [1,3])
Other Liver disease conditions - MedDRA lower level term code
Item
Other Liver disease conditions - MedDRA lower level term code
text
C0023895 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C3898442 (UMLS CUI [1,3])
Other Liver disease conditions - Failed coding
Item
Other Liver disease conditions - Failed coding
text
C0023895 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C0231175 (UMLS CUI [1,4])
Item
Other Liver disease conditions - Status
integer
C0023895 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
Other Liver disease conditions - Status
Code List
Other Liver disease conditions - Status
CL Item
Current (1)
CL Item
Past (2)
Item Group
Other medical conditions
C0012634 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
Item
Other medical condition
integer
C0012634 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Other medical condition
Code List
Other medical condition
CL Item
Drug Allergies (1)
CL Item
Rheumatoid Arthritis (2)
CL Item
Psoriasis (3)
CL Item
Thyroid Disease (4)
CL Item
Inflammatory Bowel Disease (5)
CL Item
Lupus (6)
CL Item
Sjogren's Syndrome (7)
CL Item
Vitiligo (8)
Item
Other medical condition
integer
C3176928 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Other medical condition
Code List
Other medical condition
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
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