ID
30164
Description
Study ID: 108414 Clinical Study ID: DBU108414 Study Title: TXA107979: A placebo-controlled, single blind, randomized two part study to investigate the tolerability, pharmacokinetics, and brainDopamine D3 receptor occupancy of increasing repeat doses ofGSK618334 for up to 21 days in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01036061 https://clinicaltrials.gov/ct2/show/NCT01036061 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK618334 Study Indication: Substance Dependence Documentation part: Liver Event
Link
https://clinicaltrials.gov/ct2/show/NCT01036061
Keywords
Versions (1)
- 5/16/18 5/16/18 -
Copyright Holder
GlaxoSmithKline
Uploaded on
May 16, 2018
DOI
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License
Creative Commons BY-NC 3.0
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Tolerability, pharmacokinetics, and brain Dopamine D3 receptor occupancy of increasing repeat doses of GSK618334 in healthy adults NCT01036061
Liver Event
- StudyEvent: ODM
Description
Liver events
Alias
- UMLS CUI-1
- C1556667
Description
liver event a serious adverse event
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1556667
Description
liver chemistry result
Data type
integer
Alias
- UMLS CUI [1,1]
- C0232741
- UMLS CUI [1,2]
- C0008000
- UMLS CUI [1,3]
- C0587081
Description
age
Data type
boolean
Alias
- UMLS CUI [1]
- C0001779
Description
If Yes, ensure Pregnancy Notification Form has been completed.
Data type
integer
Alias
- UMLS CUI [1]
- C0032961
Description
diagnostic imaging tests of the liver or hepatobiliary system
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0011923
- UMLS CUI [1,2]
- C0023884
- UMLS CUI [1,3]
- C1711359
Description
If No, record the details on the Non-Serious Adverse Events form or Serious Adverse Event form.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0011923
- UMLS CUI [1,2]
- C1274040
Description
If Yes, complete Liver Biopsy form.
Data type
boolean
Alias
- UMLS CUI [1]
- C0193388
Description
If Yes, record on the appropriate Concomitant Medication form.
Data type
boolean
Alias
- UMLS CUI [1]
- C0002346
- UMLS CUI [2]
- C0242295
- UMLS CUI [3]
- C0281875
Description
fasting or significant dietary change
Data type
boolean
Alias
- UMLS CUI [1]
- C3671772
- UMLS CUI [2]
- C0015663
Description
Liver Event - Investigational Product (Liver)
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0023884
- UMLS CUI-3
- C1556667
Description
liver event timepoint
Data type
integer
Alias
- UMLS CUI [1,1]
- C1556667
- UMLS CUI [1,2]
- C2348792
Description
If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period.
Data type
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
Description
If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period.
Data type
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
Description
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.
Data type
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
Description
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.
Data type
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
Description
Liver Event - Pharmacokinetics
Alias
- UMLS CUI-1
- C0031327
- UMLS CUI-2
- C1556667
Description
An unscheduled PK sample must be obtained within < insert time interval recommended by Clinical pharmacokinetics representative > of last dose
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0031328
Description
Date sample taken
Data type
date
Alias
- UMLS CUI [1]
- C1302413
Description
Time sample taken
Data type
time
Alias
- UMLS CUI [1,1]
- C0200345
- UMLS CUI [1,2]
- C0040223
Description
Date of last investigational product dose
Data type
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1762893
Description
Time of last investigational product dose
Data type
time
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1762893
- UMLS CUI [1,3]
- C0040223
Similar models
Liver Event
- StudyEvent: ODM
C1556667 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
C0023884 (UMLS CUI [1,2])
C1711359 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,2])
C0242295 (UMLS CUI [2])
C0281875 (UMLS CUI [3])
C0015663 (UMLS CUI [2])
C0023884 (UMLS CUI-2)
C1556667 (UMLS CUI-3)
C2348792 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C1556667 (UMLS CUI-2)
C0031328 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C1762893 (UMLS CUI [1,2])
C1762893 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])