ID
39875
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)
- 2/26/20 2/26/20 -
- 3/4/20 3/4/20 -
- 3/5/20 3/5/20 - Sarah Riepenhausen
Copyright Holder
GlaxoSmithKline
Uploaded on
February 26, 2020
DOI
To request one please log in.
License
Creative Commons BY-NC 4.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
Safety, tolerability and pharmacodynamics of Elubrixin in cystic fibrosis patients, NCT00903201
Liver events
- StudyEvent: ODM
Description
Liver event
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
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
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
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
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
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
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
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
Description
Age
Data type
text
Alias
- UMLS CUI [1]
- C0001779
Description
If you tick yes, ensure Pregnancy Notification Form has been completed.
Data type
text
Alias
- UMLS CUI [1]
- C0032961
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
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
Description
If you tick yes, complete Liver Biopsy form.
Data type
text
Alias
- UMLS CUI [1]
- C0193388
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
Description
Fast or significant dietary change
Data type
text
Alias
- UMLS CUI [1]
- C0015663
- UMLS CUI [2]
- C3671772
Description
Evaluation interval code
Data type
text
Alias
- UMLS CUI [1]
- C2985767
Description
Investigational product (Liver)
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0023884
Description
day month year. Note: Only complete dates for the treatment period where the liver event occurred. 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. If the date is not applicaple tick the appropriate item "Date not applicable".
Data type
partialDate
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
Description
day month year. Note: Only complete dates for the treatment period where the liver event occurred. 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. If the date is not applicaple tick the appropriate item "Date not applicable".
Data type
partialDate
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
Description
Date not applicable
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1272460
- UMLS CUI [1,2]
- C0011008
Description
Pharmacokinetics (Liver PK)
Alias
- UMLS CUI-1
- C0031327
Description
Pharmacokinetic blood sample
Data type
text
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0178913
Description
day month year
Data type
date
Alias
- UMLS CUI [1]
- C1302413
Description
00:00-23:59
Data type
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200345
Description
day month year
Data type
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1762893
Description
00:00-23:59
Data type
time
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0946444
Description
Sample Identifier/Sample Number
Data type
text
Alias
- UMLS CUI [1]
- C1299222
Description
Liver disease medical conditions
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0262926
Description
Specific Condition
Data type
integer
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2348235
Description
Tick only one response for each condition
Data type
integer
Alias
- UMLS CUI [1,1]
- C3854307
- UMLS CUI [1,2]
- C0012634
Description
Drug related liver disease conditions (All drugs including lnvestigational Product)
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0277579
Description
Other liver disease conditions
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0205394
Description
In the original form this item is hidden.
Data type
integer
Alias
- UMLS CUI [1]
- C2348184
Description
Specific condition
Data type
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2348235
Description
In the original form this item is hidden.
Data type
text
Alias
- UMLS CUI [1]
- C2826302
Description
In the original form this item is hidden.
Data type
text
Alias
- UMLS CUI [1,1]
- C1140263
- UMLS CUI [1,2]
- C0871468
Description
In the original form this item is hidden.
Data type
text
Alias
- UMLS CUI [1]
- C3898442
Description
In the original form this item is hidden.
Data type
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Description
This item is optional
Data type
integer
Alias
- UMLS CUI [1]
- C0449438
Description
Other medical conditions
Alias
- UMLS CUI-1
- C0012634
- UMLS CUI-2
- C0205394
Description
Disease
Data type
integer
Alias
- UMLS CUI [1]
- C0012634
Description
Presence of disease
Data type
integer
Alias
- UMLS CUI [1,1]
- C3854307
- UMLS CUI [1,2]
- C0012634
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
Description
Consumption of alcohol
Data type
text
Alias
- UMLS CUI [1]
- C0001948
Description
Alcohol consumption per week
Data type
float
Measurement units
- units per week
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C0560579
Description
In the original form this item is hidden.
Data type
text
Alias
- UMLS CUI [1]
- C0038586
Similar models
Liver events
- StudyEvent: ODM
C2746065 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
C2746065 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
C2746065 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
C2746065 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
C2746065 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
C2746065 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
C2746065 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
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])
C0011923 (UMLS CUI [1,2])
C1148474 (UMLS CUI [2,1])
C0002346 (UMLS CUI [2,2])
C0242295 (UMLS CUI [3])
C0086190 (UMLS CUI [4])
C3671772 (UMLS CUI [2])
C0023884 (UMLS CUI-2)
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,2])
C1762893 (UMLS CUI [1,2])
C0946444 (UMLS CUI [1,2])
C0262926 (UMLS CUI-2)
C2348235 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,2])
C0277579 (UMLS CUI-2)
C0277579 (UMLS CUI [1,2])
C0205394 (UMLS CUI-2)
C2348235 (UMLS CUI [1,2])
C0871468 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,2])
C0205394 (UMLS CUI-2)
C0012634 (UMLS CUI [1,2])
C0023884 (UMLS CUI-2)
C0332162 (UMLS CUI-3)
C0877248 (UMLS CUI-4)
C0560579 (UMLS CUI [1,2])