ID
30164
Beskrivning
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
Länk
https://clinicaltrials.gov/ct2/show/NCT01036061
Nyckelord
Versioner (1)
- 2018-05-16 2018-05-16 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
16 maj 2018
DOI
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Licens
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
Beskrivning
Liver events
Alias
- UMLS CUI-1
- C1556667
Beskrivning
liver event a serious adverse event
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1556667
Beskrivning
liver chemistry result
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0232741
- UMLS CUI [1,2]
- C0008000
- UMLS CUI [1,3]
- C0587081
Beskrivning
age
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0001779
Beskrivning
If Yes, ensure Pregnancy Notification Form has been completed.
Datatyp
integer
Alias
- UMLS CUI [1]
- C0032961
Beskrivning
diagnostic imaging tests of the liver or hepatobiliary system
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0011923
- UMLS CUI [1,2]
- C0023884
- UMLS CUI [1,3]
- C1711359
Beskrivning
If No, record the details on the Non-Serious Adverse Events form or Serious Adverse Event form.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0011923
- UMLS CUI [1,2]
- C1274040
Beskrivning
If Yes, complete Liver Biopsy form.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0193388
Beskrivning
If Yes, record on the appropriate Concomitant Medication form.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0002346
- UMLS CUI [2]
- C0242295
- UMLS CUI [3]
- C0281875
Beskrivning
fasting or significant dietary change
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3671772
- UMLS CUI [2]
- C0015663
Beskrivning
Liver Event - Investigational Product (Liver)
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0023884
- UMLS CUI-3
- C1556667
Beskrivning
liver event timepoint
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1556667
- UMLS CUI [1,2]
- C2348792
Beskrivning
If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period.
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
Beskrivning
If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period.
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
Beskrivning
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.
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
Beskrivning
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.
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
Beskrivning
Liver Event - Pharmacokinetics
Alias
- UMLS CUI-1
- C0031327
- UMLS CUI-2
- C1556667
Beskrivning
An unscheduled PK sample must be obtained within < insert time interval recommended by Clinical pharmacokinetics representative > of last dose
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0031328
Beskrivning
Date sample taken
Datatyp
date
Alias
- UMLS CUI [1]
- C1302413
Beskrivning
Time sample taken
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0200345
- UMLS CUI [1,2]
- C0040223
Beskrivning
Date of last investigational product dose
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1762893
Beskrivning
Time of last investigational product dose
Datatyp
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])