ID

39940

Description

Study ID: 110399 Clinical Study ID: 110399 Study Title: A randomized, double blind, parallel group, placebo controlled 28 day study to investigate the safety, tolerability and pharmacodynamics of SB-656933 in subjects with cystic fibrosis. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00903201 https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB656933, Placebo Trade Name: N/A Study Indication: Cystic Fibrosis The study consists of a screening, five study visits and a follow-up (time relative to Baseline in days): Visit 1: Screening, Day -28 to -16 Visit 2a: Day -7 to -4 Visit 2b: Day 1 Visit 3: Day 14 Visit 4: Day 21 Visit 5: Day 28 Visit 6: Early Withdrawal/ Follow-up, Day 35 to 42. From day 1 to day 28 the patients will receive daily doses. This document contains the liver events form. It has to be filled in if a liver event occurs during the study.

Link

https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201

Keywords

Versions (3)
  1. 2/26/20 2/26/20 -
  2. 3/4/20 3/4/20 -
  3. 3/5/20 3/5/20 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

March 5, 2020

DOI

To request one please log in.

License

Creative Commons BY-NC 4.0
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Safety, tolerability and pharmacodynamics of Elubrixin in cystic fibrosis patients, NCT00903201

English

Liver events

1 forms  
  1. StudyEvent: ODM
    1. Liver events
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Data type

text

Alias
UMLS CUI [1]
C2348585
Liver event
Description

Liver event

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0877248
ALT (alanine aminotransferase)
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0151905
UMLS CUI [1,2]
C2746065
UMLS CUI [1,3]
C0243161
AST (aspartate aminotransferase)
Description

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

Data type

boolean

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

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

Data type

boolean

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

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

Data type

boolean

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

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

Data type

boolean

Alias
UMLS CUI [1,1]
C2700357
UMLS CUI [1,2]
C2746065
UMLS CUI [1,3]
C0243161
Gammaglutamyltranspeptidase
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0541979
UMLS CUI [1,2]
C2746065
UMLS CUI [1,3]
C0243161
Other
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C2746065
UMLS CUI [1,3]
C0243161
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 you tick 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

Diagnostic Imaging tests of the liver or hepatobiliary system

Data type

text

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0023884
UMLS CUI [1,3]
C1711359
UMLS CUI [2,1]
C0041618
UMLS CUI [2,2]
C0023884
UMLS CUI [3]
C1275400
UMLS CUI [4]
C0024485
UMLS CUI [5]
C0008310
If diagnostic imaging tests were performed, were the results normal?
Description

If no, record the details on theNon-serious Adverse Event form or Serious Adverse Event form.

Data type

text

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

If you tick yes, complete Liver Biopsy form.

Data type

text

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

If you tick yes, record on the appropriate Concomitant Medication form.

Data type

text

Alias
UMLS CUI [1]
C2240391
UMLS CUI [2,1]
C1148474
UMLS CUI [2,2]
C0002346
UMLS CUI [3]
C0242295
UMLS CUI [4]
C0086190
Did the subject fast or undergo significant dietary change In the past week?
Description

Fast or significant dietary change

Data type

text

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

Evaluation interval code

Data type

text

Alias
UMLS CUI [1]
C2985767
Investigational product (Liver)
Description

Investigational product (Liver)

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

Onset of liver event

Data type

text

Alias
UMLS CUI [1,1]
C2985916
UMLS CUI [1,2]
C0023884
Start Date assessment
Description

Start Date assessment

Data type

integer

Alias
UMLS CUI [1,1]
C1516048
UMLS CUI [1,2]
C0808070
Start Date investigational Product
Description

Start Date investigational Product

Data type

partialDate

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

End Date assessment

Data type

integer

Alias
UMLS CUI [1,1]
C1516048
UMLS CUI [1,2]
C0806020
End Date investigational Product
Description

End Date investigational Product

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
C0031327
Was a pharmacokinetic blood sample obtained?
Description

Pharmacokinetic blood sample

Data type

text

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0178913
If a pharmacokinetic blood sample was taken note the Date
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C1302413
UMLS CUI [1,2]
C0031328
If a pharmacokinetic blood sample was taken note the time
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0031328
If a pharmacokinetic blood sample was taken note the Date of last investigational product dose prior to PK sample
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1762893
If a pharmacokinetic blood sample was taken note the time of last investigational product dose prior to PK sample
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0946444
Sample Identifier/Sample Number
Description

Sample Identifier/Sample Number

Data type

text

Alias
UMLS CUI [1]
C1299222
Liver disease medical conditions
Description

Liver disease medical conditions

Alias
UMLS CUI-1
C0023895
UMLS CUI-2
C0262926
Specific Condition
Description

Specific Condition

Data type

integer

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348235
Presence of disease
Description

Tick only one response for each condition

Data type

integer

Alias
UMLS CUI [1,1]
C3854307
UMLS CUI [1,2]
C0012634
Drug related liver disease conditions (All drugs including lnvestigational Product)
Description

Drug related liver disease conditions (All drugs including lnvestigational Product)

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

Drug related liver disease

Data type

integer

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

Other liver disease conditions

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

In the original form this item is hidden.

Data type

integer

Alias
UMLS CUI [1]
C2348184
Specific condition
Description

Specific condition

Data type

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348235
Modified Term
Description

In the original form this item is hidden.

Data type

text

Alias
UMLS CUI [1]
C2826302
MeDRA Synonym
Description

In the original form this item is hidden.

Data type

text

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

In the original form this item is hidden.

Data type

text

Alias
UMLS CUI [1]
C3898442
Failed coding
Description

In the original form this item is hidden.

Data type

text

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

This item is optional

Data type

integer

Alias
UMLS CUI [1]
C0449438
Other medical conditions
Description

Other medical conditions

Alias
UMLS CUI-1
C0012634
UMLS CUI-2
C0205394
Disease
Description

Disease

Data type

integer

Alias
UMLS CUI [1]
C0012634
Presence of disease
Description

Presence of disease

Data type

integer

Alias
UMLS CUI [1,1]
C3854307
UMLS CUI [1,2]
C0012634
Alcohol intake at onset of liver event (Liver alcohol)
Description

Alcohol intake at onset of liver event (Liver alcohol)

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

Consumption of alcohol

Data type

text

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

Alcohol consumption per week

Data type

float

Measurement units
  • units per week
Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0560579
units per week
Substance use type
Description

In the original form this item is hidden.

Data type

text

Alias
UMLS CUI [1]
C0038586
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Similar models

Liver events

1 forms
  1. StudyEvent: ODM
    1. Liver events
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item Group
Liver event
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
Stopping criteria: ALT (alanine aminotransferase)
Item
ALT (alanine aminotransferase)
boolean
C0151905 (UMLS CUI [1,1])
C2746065 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
Stopping criteria: AST (aspartate aminotransferase)
Item
AST (aspartate aminotransferase)
boolean
C0201899 (UMLS CUI [1,1])
C2746065 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
Stopping criteria: Total bilirubin
Item
Total bilirubin
boolean
C0201913 (UMLS CUI [1,1])
C2746065 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
Stopping criteria: Alkaline phosphatase
Item
Alkaline phosphatase
boolean
C0201850 (UMLS CUI [1,1])
C2746065 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
Stopping criteria: 5' nucleotidase
Item
5' nucleotidase
boolean
C2700357 (UMLS CUI [1,1])
C2746065 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
Stopping criteria: Gammaglutamyltranspeptidase
Item
Gammaglutamyltranspeptidase
boolean
C0541979 (UMLS CUI [1,1])
C2746065 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
Stopping criteria: Other
Item
Other
boolean
C0205394 (UMLS CUI [1,1])
C2746065 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
Item
Is the subject age 55 or older?
text
C0001779 (UMLS CUI [1])
Age
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])
C0023884 (UMLS CUI [1,2])
C1711359 (UMLS CUI [1,3])
C0041618 (UMLS CUI [2,1])
C0023884 (UMLS CUI [2,2])
C1275400 (UMLS CUI [3])
C0024485 (UMLS CUI [4])
C0008310 (UMLS CUI [5])
Diagnostic Imaging tests of the liver or hepatobiliary system
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 diagnostic imaging tests were performed, were the results normal?
text
C1274040 (UMLS CUI [1,1])
C0011923 (UMLS CUI [1,2])
Result of diagnostic imaging tests
Code List
If diagnostic imaging tests were performed, were the results normal?
CL Item
Yes (Y)
CL Item
No (N)
Item
Were any liver biopsies performed?
text
C0193388 (UMLS CUI [1])
Liver biopsies
Code List
Were any liver biopsies performed?
CL Item
Yes (Y)
CL Item
No (N)
Item
Does the subject use herbals, complementary or altemative medicines, food supplements (vitamins) or illicit drugs?
text
C2240391 (UMLS CUI [1])
C1148474 (UMLS CUI [2,1])
C0002346 (UMLS CUI [2,2])
C0242295 (UMLS CUI [3])
C0086190 (UMLS CUI [4])
Use of herbals, complementary or altemative medicines, food supplements, illicit drugs
Code List
Does the subject use herbals, complementary or altemative 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
C0015663 (UMLS CUI [1])
C3671772 (UMLS CUI [2])
Fast or significant dietary change
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
C2985767 (UMLS CUI [1])
Item Group
Investigational product (Liver)
C0304229 (UMLS CUI-1)
C0023884 (UMLS CUI-2)
Item
When did the liver event occur?
text
C2985916 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
Onset of liver event
Code List
When did the liver event occur?
CL Item
During the treatment period (D)
CL Item
After the treatment period (A)
Item
Start Date assessment
integer
C1516048 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Onset of liver event
Code List
Start Date assessment
CL Item
Not applicable (98)
CL Item
Date (99)
Start Date investigational Product
Item
Start Date investigational Product
partialDate
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
End Date assessment
integer
C1516048 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Onset of liver event
Code List
End Date assessment
CL Item
Not applicable (98)
CL Item
Date (99)
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)
C0031327 (UMLS CUI-1)
Item
Was a pharmacokinetic blood sample obtained?
text
C0031328 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
Pharmacokinetic blood sample
Code List
Was a pharmacokinetic blood sample obtained?
CL Item
Yes (Y)
CL Item
No (N)
Pharmacokinetic, date sample taken
Item
If a pharmacokinetic blood sample was taken note the Date
date
C1302413 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
Pharmacokinetic, time sample taken
Item
If a pharmacokinetic blood sample was taken note the time
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0031328 (UMLS CUI [1,3])
Date of last investigational product dose
Item
If a pharmacokinetic blood sample was taken note the Date of last investigational product dose prior to PK sample
date
C0304229 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
Time of last investigational product dose
Item
If a pharmacokinetic blood sample was taken note the time of last investigational product dose prior to PK sample
time
C0304229 (UMLS CUI [1,1])
C0946444 (UMLS CUI [1,2])
Sample Identifier/Sample Number
Item
Sample Identifier/Sample Number
text
C1299222 (UMLS CUI [1])
Item Group
Liver disease medical conditions
C0023895 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
Item
Specific Condition
integer
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Specific Condition
Code List
Specific 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
Presence of disease
integer
C3854307 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Presence of disease
Code List
Presence of disease
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item Group
Drug related liver disease conditions (All drugs including lnvestigational Product)
C0023895 (UMLS CUI-1)
C0277579 (UMLS CUI-2)
Item
Drug related liver disease
integer
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 (3)
Item Group
Other liver disease conditions
C0023895 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
Sequence Number
Item
Sequence Number
integer
C2348184 (UMLS CUI [1])
Specific condition
Item
Specific condition
text
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Modified Term
Item
Modified Term
text
C2826302 (UMLS CUI [1])
MeDRA Synonym
Item
MeDRA Synonym
text
C1140263 (UMLS CUI [1,1])
C0871468 (UMLS CUI [1,2])
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
integer
C0449438 (UMLS CUI [1])
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
Disease
integer
C0012634 (UMLS CUI [1])
Disease
Code List
Disease
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
Presence of disease
integer
C3854307 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Presence of disease
Code List
Presence of disease
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item Group
Alcohol intake at onset of liver event (Liver alcohol)
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])
Consumption of alcohol
Code List
Does the subject consume alcohol?
CL Item
No (N)
CL Item
Yes (Y)
Alcohol consumption per week
Item
If alcohol consumption, 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
C0038586 (UMLS CUI [1])
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