ID
39875
Descripción
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
Palabras clave
Versiones (3)
- 26/2/20 26/2/20 -
- 4/3/20 4/3/20 -
- 5/3/20 5/3/20 - Sarah Riepenhausen
Titular de derechos de autor
GlaxoSmithKline
Subido en
26 de febrero de 2020
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
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
Descripción
Liver event
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
Descripción
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0151905
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Descripción
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0201899
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Descripción
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0201913
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Descripción
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0201850
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Descripción
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C2700357
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Descripción
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0541979
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Descripción
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Descripción
Age
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0001779
Descripción
If you tick yes, ensure Pregnancy Notification Form has been completed.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0032961
Descripción
Diagnostic Imaging tests of the liver or hepatobiliary system
Tipo de datos
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
Descripción
If no, record the details on theNon-serious Adverse Event form or Serious Adverse Event form.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0011923
Descripción
If you tick yes, complete Liver Biopsy form.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0193388
Descripción
If you tick yes, record on the appropriate Concomitant Medication form.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2240391
- UMLS CUI [2,1]
- C1148474
- UMLS CUI [2,2]
- C0002346
- UMLS CUI [3]
- C0242295
- UMLS CUI [4]
- C0086190
Descripción
Fast or significant dietary change
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0015663
- UMLS CUI [2]
- C3671772
Descripción
Evaluation interval code
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2985767
Descripción
Investigational product (Liver)
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0023884
Descripción
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".
Tipo de datos
partialDate
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
Descripción
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".
Tipo de datos
partialDate
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
Descripción
Date not applicable
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1272460
- UMLS CUI [1,2]
- C0011008
Descripción
Pharmacokinetics (Liver PK)
Alias
- UMLS CUI-1
- C0031327
Descripción
Pharmacokinetic blood sample
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0178913
Descripción
day month year
Tipo de datos
date
Alias
- UMLS CUI [1]
- C1302413
Descripción
00:00-23:59
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200345
Descripción
day month year
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1762893
Descripción
00:00-23:59
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0946444
Descripción
Sample Identifier/Sample Number
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1299222
Descripción
Liver disease medical conditions
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0262926
Descripción
Specific Condition
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2348235
Descripción
Tick only one response for each condition
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C3854307
- UMLS CUI [1,2]
- C0012634
Descripción
Drug related liver disease conditions (All drugs including lnvestigational Product)
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0277579
Descripción
Other liver disease conditions
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0205394
Descripción
In the original form this item is hidden.
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C2348184
Descripción
Specific condition
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2348235
Descripción
In the original form this item is hidden.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2826302
Descripción
In the original form this item is hidden.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1140263
- UMLS CUI [1,2]
- C0871468
Descripción
In the original form this item is hidden.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C3898442
Descripción
In the original form this item is hidden.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Descripción
This item is optional
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0449438
Descripción
Other medical conditions
Alias
- UMLS CUI-1
- C0012634
- UMLS CUI-2
- C0205394
Descripción
Disease
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0012634
Descripción
Presence of disease
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C3854307
- UMLS CUI [1,2]
- C0012634
Descripción
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
Descripción
Consumption of alcohol
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0001948
Descripción
Alcohol consumption per week
Tipo de datos
float
Unidades de medida
- units per week
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C0560579
Descripción
In the original form this item is hidden.
Tipo de datos
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])