ID
39875
Beschreibung
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
Stichworte
Versionen (3)
- 26.02.20 26.02.20 -
- 04.03.20 04.03.20 -
- 05.03.20 05.03.20 - Sarah Riepenhausen
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
26. Februar 2020
DOI
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Lizenz
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
Beschreibung
Liver event
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
Beschreibung
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0151905
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Beschreibung
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0201899
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Beschreibung
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0201913
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Beschreibung
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0201850
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Beschreibung
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2700357
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Beschreibung
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0541979
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Beschreibung
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Beschreibung
Age
Datentyp
text
Alias
- UMLS CUI [1]
- C0001779
Beschreibung
If you tick yes, ensure Pregnancy Notification Form has been completed.
Datentyp
text
Alias
- UMLS CUI [1]
- C0032961
Beschreibung
Diagnostic Imaging tests of the liver or hepatobiliary system
Datentyp
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
Beschreibung
If no, record the details on theNon-serious Adverse Event form or Serious Adverse Event form.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0011923
Beschreibung
If you tick yes, complete Liver Biopsy form.
Datentyp
text
Alias
- UMLS CUI [1]
- C0193388
Beschreibung
If you tick yes, record on the appropriate Concomitant Medication form.
Datentyp
text
Alias
- UMLS CUI [1]
- C2240391
- UMLS CUI [2,1]
- C1148474
- UMLS CUI [2,2]
- C0002346
- UMLS CUI [3]
- C0242295
- UMLS CUI [4]
- C0086190
Beschreibung
Fast or significant dietary change
Datentyp
text
Alias
- UMLS CUI [1]
- C0015663
- UMLS CUI [2]
- C3671772
Beschreibung
Evaluation interval code
Datentyp
text
Alias
- UMLS CUI [1]
- C2985767
Beschreibung
Investigational product (Liver)
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0023884
Beschreibung
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".
Datentyp
partialDate
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
Beschreibung
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".
Datentyp
partialDate
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
Beschreibung
Date not applicable
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1272460
- UMLS CUI [1,2]
- C0011008
Beschreibung
Pharmacokinetics (Liver PK)
Alias
- UMLS CUI-1
- C0031327
Beschreibung
Pharmacokinetic blood sample
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0178913
Beschreibung
day month year
Datentyp
date
Alias
- UMLS CUI [1]
- C1302413
Beschreibung
00:00-23:59
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200345
Beschreibung
day month year
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1762893
Beschreibung
00:00-23:59
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0946444
Beschreibung
Sample Identifier/Sample Number
Datentyp
text
Alias
- UMLS CUI [1]
- C1299222
Beschreibung
Liver disease medical conditions
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0262926
Beschreibung
Specific Condition
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2348235
Beschreibung
Tick only one response for each condition
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C3854307
- UMLS CUI [1,2]
- C0012634
Beschreibung
Drug related liver disease conditions (All drugs including lnvestigational Product)
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0277579
Beschreibung
Other liver disease conditions
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0205394
Beschreibung
In the original form this item is hidden.
Datentyp
integer
Alias
- UMLS CUI [1]
- C2348184
Beschreibung
Specific condition
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2348235
Beschreibung
In the original form this item is hidden.
Datentyp
text
Alias
- UMLS CUI [1]
- C2826302
Beschreibung
In the original form this item is hidden.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1140263
- UMLS CUI [1,2]
- C0871468
Beschreibung
In the original form this item is hidden.
Datentyp
text
Alias
- UMLS CUI [1]
- C3898442
Beschreibung
In the original form this item is hidden.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Beschreibung
This item is optional
Datentyp
integer
Alias
- UMLS CUI [1]
- C0449438
Beschreibung
Other medical conditions
Alias
- UMLS CUI-1
- C0012634
- UMLS CUI-2
- C0205394
Beschreibung
Disease
Datentyp
integer
Alias
- UMLS CUI [1]
- C0012634
Beschreibung
Presence of disease
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C3854307
- UMLS CUI [1,2]
- C0012634
Beschreibung
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
Beschreibung
Consumption of alcohol
Datentyp
text
Alias
- UMLS CUI [1]
- C0001948
Beschreibung
Alcohol consumption per week
Datentyp
float
Maßeinheiten
- units per week
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C0560579
Beschreibung
In the original form this item is hidden.
Datentyp
text
Alias
- UMLS CUI [1]
- C0038586
Ähnliche Modelle
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])