ID
39875
Beschrijving
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
Trefwoorden
Versies (3)
- 26-02-20 26-02-20 -
- 04-03-20 04-03-20 -
- 05-03-20 05-03-20 - Sarah Riepenhausen
Houder van rechten
GlaxoSmithKline
Geüploaded op
26 februari 2020
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 4.0
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Safety, tolerability and pharmacodynamics of Elubrixin in cystic fibrosis patients, NCT00903201
Liver events
- StudyEvent: ODM
Beschrijving
Liver event
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
Beschrijving
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0151905
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Beschrijving
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0201899
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Beschrijving
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0201913
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Beschrijving
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0201850
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Beschrijving
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2700357
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Beschrijving
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0541979
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Beschrijving
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Beschrijving
Age
Datatype
text
Alias
- UMLS CUI [1]
- C0001779
Beschrijving
If you tick yes, ensure Pregnancy Notification Form has been completed.
Datatype
text
Alias
- UMLS CUI [1]
- C0032961
Beschrijving
Diagnostic Imaging tests of the liver or hepatobiliary system
Datatype
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
Beschrijving
If no, record the details on theNon-serious Adverse Event form or Serious Adverse Event form.
Datatype
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0011923
Beschrijving
If you tick yes, complete Liver Biopsy form.
Datatype
text
Alias
- UMLS CUI [1]
- C0193388
Beschrijving
If you tick yes, record on the appropriate Concomitant Medication form.
Datatype
text
Alias
- UMLS CUI [1]
- C2240391
- UMLS CUI [2,1]
- C1148474
- UMLS CUI [2,2]
- C0002346
- UMLS CUI [3]
- C0242295
- UMLS CUI [4]
- C0086190
Beschrijving
Fast or significant dietary change
Datatype
text
Alias
- UMLS CUI [1]
- C0015663
- UMLS CUI [2]
- C3671772
Beschrijving
Evaluation interval code
Datatype
text
Alias
- UMLS CUI [1]
- C2985767
Beschrijving
Investigational product (Liver)
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0023884
Beschrijving
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".
Datatype
partialDate
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
Beschrijving
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".
Datatype
partialDate
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
Beschrijving
Date not applicable
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1272460
- UMLS CUI [1,2]
- C0011008
Beschrijving
Pharmacokinetics (Liver PK)
Alias
- UMLS CUI-1
- C0031327
Beschrijving
Pharmacokinetic blood sample
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0178913
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1]
- C1302413
Beschrijving
00:00-23:59
Datatype
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200345
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1762893
Beschrijving
00:00-23:59
Datatype
time
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0946444
Beschrijving
Sample Identifier/Sample Number
Datatype
text
Alias
- UMLS CUI [1]
- C1299222
Beschrijving
Liver disease medical conditions
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0262926
Beschrijving
Specific Condition
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2348235
Beschrijving
Tick only one response for each condition
Datatype
integer
Alias
- UMLS CUI [1,1]
- C3854307
- UMLS CUI [1,2]
- C0012634
Beschrijving
Drug related liver disease conditions (All drugs including lnvestigational Product)
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0277579
Beschrijving
Other liver disease conditions
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0205394
Beschrijving
In the original form this item is hidden.
Datatype
integer
Alias
- UMLS CUI [1]
- C2348184
Beschrijving
Specific condition
Datatype
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2348235
Beschrijving
In the original form this item is hidden.
Datatype
text
Alias
- UMLS CUI [1]
- C2826302
Beschrijving
In the original form this item is hidden.
Datatype
text
Alias
- UMLS CUI [1,1]
- C1140263
- UMLS CUI [1,2]
- C0871468
Beschrijving
In the original form this item is hidden.
Datatype
text
Alias
- UMLS CUI [1]
- C3898442
Beschrijving
In the original form this item is hidden.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Beschrijving
This item is optional
Datatype
integer
Alias
- UMLS CUI [1]
- C0449438
Beschrijving
Other medical conditions
Alias
- UMLS CUI-1
- C0012634
- UMLS CUI-2
- C0205394
Beschrijving
Disease
Datatype
integer
Alias
- UMLS CUI [1]
- C0012634
Beschrijving
Presence of disease
Datatype
integer
Alias
- UMLS CUI [1,1]
- C3854307
- UMLS CUI [1,2]
- C0012634
Beschrijving
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
Beschrijving
Consumption of alcohol
Datatype
text
Alias
- UMLS CUI [1]
- C0001948
Beschrijving
Alcohol consumption per week
Datatype
float
Maateenheden
- units per week
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C0560579
Beschrijving
In the original form this item is hidden.
Datatype
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])