ID

38601

Description

Study ID: 110951 Clinical Study ID: 110951 Study Title: A two-part, randomised, placebo-controlled study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single doses of intravenously infused GSK1995057 in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01476046 See https://clinicaltrials.gov/ct2/show/NCT01476046 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: N/A, Placebo Trade Name: N/A Study Indication: Respiratory Disorders The single-centre study consists of two parts A and B with seven cohorts/ten subcohorts in total. Part A includes ascending doses of the investigational product given to subjects negative or positive for pre-existing human anti-heavy chain variable domain (HAVH) antibodies (Cohorts 1 to 3 with Subcohorts 1a, 2a and 3a negative for HAVH and 1b, 2b, 3b positive for HAVH). Part B includes only subjects negative for HAVH, with ascending doses given to Cohorts 4 to 6. Cohort 7 receives the same dose as Cohort 6, but whereas the other Cohorts are single-blinded, Cohort 7 is open-label and additionally receives a bronchoalveolar lavage (BAL). The study consists of a Screening Visit (up to 56 days before Day 1, the day of the drug administration), Visits on Day -1, 1, 2, 3, 5, 7, 14, 28 and Follow-Up Visits on Day 57 and 85. This form contains general information on any Liver Event happening during the study, including whether and when a pharmacokinetic sample has been obtained as well as information on the subject's general and liver-related medical conditions and alcohol intake. There are seperate forms for Imaging and Biopsy in case of a Liver Event.

Link

https://clinicaltrials.gov/ct2/show/NCT01476046

Keywords

Versions (1)
  1. 10/26/19 10/26/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 26, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Phase I Trial of Intravenous TNFR1 Antagonist GSK1995057 in Healthy Subjects - NCT01476046

English

Liver Events incl. Pharmacokinetics, Medical Conditions, Alcohol

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Date/Time of Assessment
Description

Date/Time of Assessment

Data type

datetime

Alias
UMLS CUI [1,1]
C2985720
UMLS CUI [1,2]
C1264639
Liver Event Seriousness
Description

Liver Event Seriousness

Alias
UMLS CUI-1
C1710056
UMLS CUI-2
C0023884
Is this liver event a serious adverse event?
Description

If yes, please complete liver event forms and serious adverse event form immediately.

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1519255
Notification Sent
Description

Notification Sent

Alias
UMLS CUI-1
C0422202
UMLS CUI-2
C0023884
Last Email Sent to Medical Monitor
Description

[read-only]

Data type

partialDatetime

Alias
UMLS CUI [1,1]
C1264639
UMLS CUI [1,2]
C0013849
UMLS CUI [1,3]
C1517741
UMLS CUI [1,4]
C1708968
Initial Email Sent to Medical Monitor
Description

[read-only]

Data type

partialDatetime

Alias
UMLS CUI [1,1]
C1264639
UMLS CUI [1,2]
C0205435
UMLS CUI [1,3]
C0013849
UMLS CUI [1,4]
C1708968
Last Email Sent to GCSP
Description

[read-only]

Data type

partialDatetime

Alias
UMLS CUI [1,1]
C1264639
UMLS CUI [1,2]
C0013849
UMLS CUI [1,3]
C1517741
UMLS CUI [1,4]
C3899555
Initial Email Sent to GCSP
Description

[read-only]

Data type

partialDatetime

Alias
UMLS CUI [1,1]
C1264639
UMLS CUI [1,2]
C0013849
UMLS CUI [1,3]
C0205435
UMLS CUI [1,4]
C3899555
Changed to Non Serious on
Description

[read-only]

Data type

partialDatetime

Alias
UMLS CUI [1,1]
C1264639
UMLS CUI [1,2]
C1710056
UMLS CUI [1,3]
C0023884
UMLS CUI [1,4]
C0443172
UMLS CUI [1,5]
C1518404
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/interruption criteria?
Description

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

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0008000
UMLS CUI-3
C0304229
UMLS CUI-4
C2746065
UMLS CUI-5
C0243161
ALT (alanine aminotransferase)
Description

It is particularly important to record any significant hypotension immediately prior to or concomitant with ALT elevation.

Data type

boolean

Alias
UMLS CUI [1,1]
C0201836
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C2746065
UMLS CUI [1,4]
C0243161
AST (aspartate aminotransferase)
Description

AST reached stopping criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0201899
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C2746065
UMLS CUI [1,4]
C0243161
Total bilirubin
Description

Total bilirubin reached stopping criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0201913
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C2746065
UMLS CUI [1,4]
C0243161
Alkaline phosphatase
Description

Alkaline phosphatase reached stopping criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0201850
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C2746065
UMLS CUI [1,4]
C0243161
5' nucleotidase
Description

This item is conditional. Interruption may be removed if stopping/monitoring study only.

Data type

boolean

Alias
UMLS CUI [1,1]
C0202148
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C2746065
UMLS CUI [1,4]
C0243161
Gammaglutamyltranspeptidase
Description

This item is conditional. Interruption may be removed if stopping/monitoring study only.

Data type

boolean

Alias
UMLS CUI [1,1]
C0202035
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C2746065
UMLS CUI [1,4]
C0243161
Other
Description

Other liver chemistry result reached stopping criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0023884
UMLS CUI [1,3]
C0008000
UMLS CUI [1,4]
C0304229
UMLS CUI [1,5]
C2746065
UMLS CUI [1,6]
C0243161
Liver Events - Clinical
Description

Liver Events - Clinical

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0877248
UMLS CUI-3
C0205210
Is the subject age 55 or older?
Description

Age

Data type

text

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

If Yes, answer whether the results were normal

Data type

text

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C1711359
UMLS CUI [2,1]
C0011923
UMLS CUI [2,2]
C0023884
UMLS CUI [3]
C0412534
UMLS CUI [4]
C0412620
UMLS CUI [5]
C0412693
UMLS CUI [6]
C0008310
If Yes, were the results normal?
Description

If applicable If No, record the details on the Imaging form. Please ensure the overall diagnosis indicated by imaging is captured on the Non-serious Adverse Event form or Serious Adverse Event form.

Data type

text

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C1711359
UMLS CUI [1,3]
C0456984
UMLS CUI [2,1]
C0011923
UMLS CUI [2,2]
C0456984
UMLS CUI [2,3]
C0023884
Were any liver biopsies performed?
Description

If yes, complete Liver Biopsy form.

Data type

text

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C1272695
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

text

Alias
UMLS CUI [1]
C2347852
UMLS CUI [2]
C0025125
UMLS CUI [3]
C0242295
UMLS CUI [4]
C0086190
Did the subject fast or undergo significant dietary change in the past week?
Description

Recent fasting or significant dietary change

Data type

text

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

[hidden] Item will be calculated by InForm.

Data type

text

Alias
UMLS CUI [1]
C2826267
Investigational Product (Liver)
Description

Investigational Product (Liver)

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0023884
When did the liver event occur?
Description

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

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C2745955
UMLS CUI [1,4]
C0439564
UMLS CUI [1,5]
C2347804
Start Date Investigational Product
Description

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

partialDate

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0808070
End Date Investigational Product
Description

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

partialDate

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0806020
Pharmacokinetics (Liver PK)
Description

Pharmacokinetics (Liver PK)

Alias
UMLS CUI-1
C0005834
UMLS CUI-2
C0031328
UMLS CUI-3
C0023884
Was a pharmacokinetic blood sample obtained?
Description

An unscheduled PK sample must be obtained within obtained within 7 days of last dose. If yes, record date and time sample taken and date and time of last investigational product dose prior to PK sample

Data type

text

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

if applicable

Data type

datetime

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0031328
UMLS CUI [1,3]
C1264639
Date and time of last investigational product dose prior to PK sample
Description

if applicable

Data type

datetime

Alias
UMLS CUI [1,1]
C0945778
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C0005834
UMLS CUI [1,5]
C0031328
Liver disease medical conditions
Description

Liver disease medical conditions

Alias
UMLS CUI-1
C0023895
Acute Viral Hepatitis A
Description

Acute type A viral hepatitis

Data type

integer

Alias
UMLS CUI [1]
C0276434
Chronic Hepatitis B
Description

Hepatitis B, Chronic

Data type

integer

Alias
UMLS CUI [1]
C0524909
Chronic Hepatitis C
Description

Hepatitis C, Chronic

Data type

integer

Alias
UMLS CUI [1]
C0524910
Cytomegalovirus Hepatitis
Description

Cytomegalovirus Hepatitis

Data type

integer

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

Infectious Mononucleosis

Data type

integer

Alias
UMLS CUI [1]
C0021345
Herpes Simplex Hepatitis
Description

Herpes Simplex Hepatitis

Data type

integer

Alias
UMLS CUI [1]
C1963747
Alcoholic Liver Disease
Description

Alcoholic Liver Diseases

Data type

integer

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

Non-alcoholic Steatohepatitis

Data type

integer

Alias
UMLS CUI [1]
C3241937
Fatty Liver
Description

Fatty Liver

Data type

integer

Alias
UMLS CUI [1]
C0015695
Hepatic Cirrhosis
Description

Hepatic Cirrhosis

Data type

integer

Alias
UMLS CUI [1]
C0023890
Hemochromatosis
Description

Hemochromatosis

Data type

integer

Alias
UMLS CUI [1]
C0018995
Autoimmune Hepatitis
Description

Autoimmune Hepatitis

Data type

integer

Alias
UMLS CUI [1]
C0241910
Gallbladder disease
Description

It is particularly important to record any gallbladder or biliary disease, or pancreatitis, that occurred during the study.

Data type

integer

Alias
UMLS CUI [1]
C0016977
Drug related liver disease conditions
Description

Drug related liver disease conditions

Alias
UMLS CUI-1
C0023895
UMLS CUI-2
C0041755
Drug related liver disease
Description

Drug related liver disease

Data type

integer

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0041755
Other Liver Disease
Description

Other Liver Disease

Alias
UMLS CUI-1
C0023895
UMLS CUI-2
C0205394
Sequence Number [hidden]
Description

[hidden]

Data type

text

Alias
UMLS CUI [1]
C2348184
Specific Condition
Description

Other liver disease

Data type

text

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205394
Modified Term [hidden]
Description

[hidden]

Data type

text

Alias
UMLS CUI [1]
C2826302
MedDRA Synonym [hidden]
Description

[hidden]

Data type

text

Alias
UMLS CUI [1,1]
C1140263
UMLS CUI [1,2]
C0871468
MedDRA lower level term code [hidden]
Description

[hidden]

Data type

text

Alias
UMLS CUI [1]
C3898442
Failed coding [hidden]
Description

[hidden]

Data type

text

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C0231175
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
Drug Allergies
Description

Drug Allergies

Data type

integer

Alias
UMLS CUI [1]
C0013182
Rheumatoid Arthritis
Description

Rheumatoid Arthritis

Data type

integer

Alias
UMLS CUI [1]
C0003873
Psoriasis
Description

Psoriasis

Data type

integer

Alias
UMLS CUI [1]
C0033860
Thyroid Disease
Description

Thyroid Disease

Data type

integer

Alias
UMLS CUI [1]
C0040128
Inflammatory Bowel Disease
Description

Inflammatory Bowel Disease

Data type

integer

Alias
UMLS CUI [1]
C0021390
Lupus
Description

Lupus

Data type

integer

Alias
UMLS CUI [1]
C0409974
Sjogren's Syndrome
Description

Sjogren's Syndrome

Data type

integer

Alias
UMLS CUI [1]
C1527336
Vitiligo
Description

Vitiligo

Data type

integer

Alias
UMLS CUI [1]
C0042900
Alcohol Intake at Onset of Liver Event
Description

Alcohol Intake at Onset of Liver Event

Alias
UMLS CUI-1
C0001948
UMLS CUI-2
C0023884
UMLS CUI-3
C0332162
UMLS CUI-4
C0877248
Does the subject consume alcohol?
Description

If Yes, record the average number of units of alcohol consumed per week

Data type

text

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

if applicable

Data type

float

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0560579
UMLS CUI [1,3]
C1510992
Substance Use Type [hidden]
Description

[hidden] This item will be calculated by InForm.

Data type

text

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C0332307
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Similar models

Liver Events incl. Pharmacokinetics, Medical Conditions, Alcohol

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Date/Time of Assessment
Item
Date/Time of Assessment
datetime
C2985720 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Item Group
Liver Event Seriousness
C1710056 (UMLS CUI-1)
C0023884 (UMLS CUI-2)
Item
Is this liver event a serious adverse event?
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Is Liver Event SAE?
Code List
Is this liver event a serious adverse event?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Notification Sent
C0422202 (UMLS CUI-1)
C0023884 (UMLS CUI-2)
Date/Time Last Email to Medical Monitor
Item
Last Email Sent to Medical Monitor
partialDatetime
C1264639 (UMLS CUI [1,1])
C0013849 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1708968 (UMLS CUI [1,4])
Date/Time First Email to Medical Monitor
Item
Initial Email Sent to Medical Monitor
partialDatetime
C1264639 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C0013849 (UMLS CUI [1,3])
C1708968 (UMLS CUI [1,4])
Date/Time Last Email to GCSP
Item
Last Email Sent to GCSP
partialDatetime
C1264639 (UMLS CUI [1,1])
C0013849 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C3899555 (UMLS CUI [1,4])
Date/Time First Email to GCSP
Item
Initial Email Sent to GCSP
partialDatetime
C1264639 (UMLS CUI [1,1])
C0013849 (UMLS CUI [1,2])
C0205435 (UMLS CUI [1,3])
C3899555 (UMLS CUI [1,4])
Date/Time Liver Event Changed to Non Serious
Item
Changed to Non Serious on
partialDatetime
C1264639 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
C0443172 (UMLS CUI [1,4])
C1518404 (UMLS CUI [1,5])
Item Group
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/interruption criteria?
C0023884 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
C2746065 (UMLS CUI-4)
C0243161 (UMLS CUI-5)
ALT reached stopping criteria
Item
ALT (alanine aminotransferase)
boolean
C0201836 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
AST reached stopping criteria
Item
AST (aspartate aminotransferase)
boolean
C0201899 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
Total bilirubin reached stopping criteria
Item
Total bilirubin
boolean
C0201913 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
Alkaline phosphatase reached stopping criteria
Item
Alkaline phosphatase
boolean
C0201850 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
5' nucleotidase reached stopping criteria
Item
5' nucleotidase
boolean
C0202148 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
Gammaglutamyltranspeptidase reached stopping criteria
Item
Gammaglutamyltranspeptidase
boolean
C0202035 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
Other liver chemistry result reached stopping criteria
Item
Other
boolean
C0205394 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C2746065 (UMLS CUI [1,5])
C0243161 (UMLS CUI [1,6])
Item Group
Liver Events - Clinical
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C0205210 (UMLS CUI-3)
Item
Is the subject age 55 or older?
text
C0001779 (UMLS CUI [1])
Is Liver Event SAE?
Code List
Is the subject age 55 or older?
CL Item
Yes (Y)
CL Item
No (N)
Item
If female, is the subject pregnant?
text
C0032961 (UMLS CUI [1])
Pregnancy
Code List
If female, is the subject pregnant?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not applicable (X)
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)?
text
C0011923 (UMLS CUI [1,1])
C1711359 (UMLS CUI [1,2])
C0011923 (UMLS CUI [2,1])
C0023884 (UMLS CUI [2,2])
C0412534 (UMLS CUI [3])
C0412620 (UMLS CUI [4])
C0412693 (UMLS CUI [5])
C0008310 (UMLS CUI [6])
Is Liver Event SAE?
Code List
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)?
CL Item
Yes (Y)
CL Item
No (N)
Item
If Yes, were the results normal?
text
C0011923 (UMLS CUI [1,1])
C1711359 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,3])
C0011923 (UMLS CUI [2,1])
C0456984 (UMLS CUI [2,2])
C0023884 (UMLS CUI [2,3])
Is Liver Event SAE?
Code List
If Yes, were the results normal?
CL Item
Yes (Y)
CL Item
No (N)
Item
Were any liver biopsies performed?
text
C0193388 (UMLS CUI [1,1])
C1272695 (UMLS CUI [1,2])
Is Liver Event SAE?
Code List
Were any liver biopsies performed?
CL Item
Yes (Y)
CL Item
No (N)
Item
Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
text
C2347852 (UMLS CUI [1])
C0025125 (UMLS CUI [2])
C0242295 (UMLS CUI [3])
C0086190 (UMLS CUI [4])
Is Liver Event SAE?
Code List
Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
CL Item
Yes (Y)
CL Item
No (N)
Item
Did the subject fast or undergo significant dietary change in the past week?
text
C3671772 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0332185 (UMLS CUI [2,1])
C0015663 (UMLS CUI [2,2])
Is Liver Event SAE?
Code List
Did the subject fast or undergo significant dietary change in the past week?
CL Item
Yes (Y)
CL Item
No (N)
Evaluation interval code
Item
Evaluation interval code [hidden]
text
C2826267 (UMLS CUI [1])
Item Group
Investigational Product (Liver)
C0304229 (UMLS CUI-1)
C0023884 (UMLS CUI-2)
Item
When did the liver event occur?
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0439564 (UMLS CUI [1,4])
C2347804 (UMLS CUI [1,5])
undefined item
Code List
When did the liver event occur?
CL Item
During the treatment period (D)
CL Item
After the treatment period (A)
Start Date Investigational Product
Item
Start Date Investigational Product
partialDate
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
End Date Investigational Product
Item
End Date Investigational Product
partialDate
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item Group
Pharmacokinetics (Liver PK)
C0005834 (UMLS CUI-1)
C0031328 (UMLS CUI-2)
C0023884 (UMLS CUI-3)
Item
Was a pharmacokinetic blood sample obtained?
text
C0005834 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
Is Liver Event SAE?
Code List
Was a pharmacokinetic blood sample obtained?
CL Item
Yes (Y)
CL Item
No (N)
Date/Time of pharmacokinetic blood sample
Item
Date and time sample taken
datetime
C0005834 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Date/Time of last investigational product dose prior to pharmacokinetic blood sample
Item
Date and time of last investigational product dose prior to PK sample
datetime
C0945778 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0005834 (UMLS CUI [1,4])
C0031328 (UMLS CUI [1,5])
Item Group
Liver disease medical conditions
C0023895 (UMLS CUI-1)
Item
Acute Viral Hepatitis A
integer
C0276434 (UMLS CUI [1])
Acute type A viral hepatitis
Code List
Acute Viral Hepatitis A
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Chronic Hepatitis B
integer
C0524909 (UMLS CUI [1])
Acute type A viral hepatitis
Code List
Chronic Hepatitis B
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Chronic Hepatitis C
integer
C0524910 (UMLS CUI [1])
Acute type A viral hepatitis
Code List
Chronic Hepatitis C
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Cytomegalovirus Hepatitis
integer
C0276252 (UMLS CUI [1])
Acute type A viral hepatitis
Code List
Cytomegalovirus Hepatitis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Epstein Barr Virus Infectious Mononucleosis
integer
C0021345 (UMLS CUI [1])
Acute type A viral hepatitis
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
integer
C1963747 (UMLS CUI [1])
Acute type A viral hepatitis
Code List
Herpes Simplex Hepatitis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Alcoholic Liver Disease
integer
C0023896 (UMLS CUI [1])
Acute type A viral hepatitis
Code List
Alcoholic Liver Disease
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Non-alcoholic Steatohepatitis
integer
C3241937 (UMLS CUI [1])
Acute type A viral hepatitis
Code List
Non-alcoholic Steatohepatitis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Fatty Liver
integer
C0015695 (UMLS CUI [1])
Acute type A viral hepatitis
Code List
Fatty Liver
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Hepatic Cirrhosis
integer
C0023890 (UMLS CUI [1])
Acute type A viral hepatitis
Code List
Hepatic Cirrhosis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Hemochromatosis
integer
C0018995 (UMLS CUI [1])
Acute type A viral hepatitis
Code List
Hemochromatosis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Autoimmune Hepatitis
integer
C0241910 (UMLS CUI [1])
Acute type A viral hepatitis
Code List
Autoimmune Hepatitis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Gallbladder disease
integer
C0016977 (UMLS CUI [1])
Acute type A viral hepatitis
Code List
Gallbladder disease
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)
C0041755 (UMLS CUI-2)
Item
Drug related liver disease
integer
C0023895 (UMLS CUI [1,1])
C0041755 (UMLS CUI [1,2])
Acute type A viral hepatitis
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
C0023895 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
Sequence Number
Item
Sequence Number [hidden]
text
C2348184 (UMLS CUI [1])
Other liver disease
Item
Specific Condition
text
C0023895 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Modified Term
Item
Modified Term [hidden]
text
C2826302 (UMLS CUI [1])
MedDRA Synonym
Item
MedDRA Synonym [hidden]
text
C1140263 (UMLS CUI [1,1])
C0871468 (UMLS CUI [1,2])
MedDRA lower level term code
Item
MedDRA lower level term code [hidden]
text
C3898442 (UMLS CUI [1])
Failed coding
Item
Failed coding [hidden]
text
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Item
Status
integer
C0023895 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
Liver diseases; Other, 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
integer
C0013182 (UMLS CUI [1])
Acute type A viral hepatitis
Code List
Drug Allergies
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Rheumatoid Arthritis
integer
C0003873 (UMLS CUI [1])
Acute type A viral hepatitis
Code List
Rheumatoid Arthritis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Psoriasis
integer
C0033860 (UMLS CUI [1])
Acute type A viral hepatitis
Code List
Psoriasis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Thyroid Disease
integer
C0040128 (UMLS CUI [1])
Acute type A viral hepatitis
Code List
Thyroid Disease
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Inflammatory Bowel Disease
integer
C0021390 (UMLS CUI [1])
Acute type A viral hepatitis
Code List
Inflammatory Bowel Disease
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Lupus
integer
C0409974 (UMLS CUI [1])
Acute type A viral hepatitis
Code List
Lupus
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Sjogren's Syndrome
integer
C1527336 (UMLS CUI [1])
Acute type A viral hepatitis
Code List
Sjogren's Syndrome
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Vitiligo
integer
C0042900 (UMLS CUI [1])
Acute type A viral hepatitis
Code List
Vitiligo
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item Group
Alcohol Intake at Onset of Liver Event
C0001948 (UMLS CUI-1)
C0023884 (UMLS CUI-2)
C0332162 (UMLS CUI-3)
C0877248 (UMLS CUI-4)
Item
Does the subject consume alcohol?
text
C0001948 (UMLS CUI [1])
Is Liver Event SAE?
Code List
Does the subject consume alcohol?
CL Item
Yes (Y)
CL Item
No (N)
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])
C1510992 (UMLS CUI [1,3])
Substance Use Type
Item
Substance Use Type [hidden]
text
C0038586 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
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