ID
39940
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
5 maart 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
Onset of liver event
Datatype
text
Alias
- UMLS CUI [1,1]
- C2985916
- UMLS CUI [1,2]
- C0023884
Beschrijving
Start Date assessment
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1516048
- UMLS CUI [1,2]
- C0808070
Beschrijving
Start Date investigational Product
Datatype
partialDate
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
Beschrijving
End Date assessment
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1516048
- UMLS CUI [1,2]
- C0806020
Beschrijving
End Date investigational Product
Datatype
partialDate
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
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 [1,1]
- C1302413
- UMLS CUI [1,2]
- C0031328
Beschrijving
00:00-23:59
Datatype
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C0031328
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)
C0023884 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,2])
C0031328 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,2])
C0031328 (UMLS CUI [1,3])
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])