ID
30164
Beschreibung
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
Stichworte
Versionen (1)
- 16.05.18 16.05.18 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
16. Mai 2018
DOI
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Lizenz
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
Beschreibung
Liver events
Alias
- UMLS CUI-1
- C1556667
Beschreibung
liver event a serious adverse event
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1556667
Beschreibung
liver chemistry result
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0232741
- UMLS CUI [1,2]
- C0008000
- UMLS CUI [1,3]
- C0587081
Beschreibung
age
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0001779
Beschreibung
If Yes, ensure Pregnancy Notification Form has been completed.
Datentyp
integer
Alias
- UMLS CUI [1]
- C0032961
Beschreibung
diagnostic imaging tests of the liver or hepatobiliary system
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0011923
- UMLS CUI [1,2]
- C0023884
- UMLS CUI [1,3]
- C1711359
Beschreibung
If No, record the details on the Non-Serious Adverse Events form or Serious Adverse Event form.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0011923
- UMLS CUI [1,2]
- C1274040
Beschreibung
If Yes, complete Liver Biopsy form.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0193388
Beschreibung
If Yes, record on the appropriate Concomitant Medication form.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0002346
- UMLS CUI [2]
- C0242295
- UMLS CUI [3]
- C0281875
Beschreibung
fasting or significant dietary change
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3671772
- UMLS CUI [2]
- C0015663
Beschreibung
Liver Event - Investigational Product (Liver)
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0023884
- UMLS CUI-3
- C1556667
Beschreibung
liver event timepoint
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1556667
- UMLS CUI [1,2]
- C2348792
Beschreibung
If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period.
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
Beschreibung
If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period.
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
Beschreibung
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.
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
Beschreibung
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.
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
Beschreibung
Liver Event - Pharmacokinetics
Alias
- UMLS CUI-1
- C0031327
- UMLS CUI-2
- C1556667
Beschreibung
An unscheduled PK sample must be obtained within < insert time interval recommended by Clinical pharmacokinetics representative > of last dose
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0031328
Beschreibung
Date sample taken
Datentyp
date
Alias
- UMLS CUI [1]
- C1302413
Beschreibung
Time sample taken
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0200345
- UMLS CUI [1,2]
- C0040223
Beschreibung
Date of last investigational product dose
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1762893
Beschreibung
Time of last investigational product dose
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1762893
- UMLS CUI [1,3]
- C0040223
Ähnliche Modelle
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])