ID

36209

Beskrivning

Study ID: 101963 Clinical Study ID: SCA101963 Study Title: A randomised, blinded, parallel group study to investigate the potential pharmacokinetic interaction between lamotrigine and risperidone in healthy, non-smoking, male volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: lamotrigine Trade Name: Lamictal XR,Lamictal,LAMICTIN Study Indication: Schizophrenia

Nyckelord

Versioner (1)
  1. 2019-04-22 2019-04-22 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

22 april 2019

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

  • Senaste
  • Äldsta
  • Önskad
  • Senaste
    • Senaste
    • Äldsta
    • Önskad

Inga kommentarer

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Potential Pharmacokinetic Interaction between Lamotrigine and Risperidone; 101963

Engelsk

PGx-Pharmacogenetic Research

1 Formulär  
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beskrivning

Clinical Trial Subject Unique Identifier

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Consent for PGx-Pharmacogenetic Research
Beskrivning

Consent for PGx-Pharmacogenetic Research

Alias
UMLS CUI-1
C2347500
UMLS CUI-2
C0021430
Has informed consent been obtained for PGx-Pharmacogenetic research?
Beskrivning

Pharmacogenetic Test, Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0021430
If Yes, record the date informed consent obtained for PGx-Pharmacogenetic research
Beskrivning

Pharmacogenetic Test, Informed Consent, Date in time

Datatyp

date

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0011008
IfNo, tick one reason
Beskrivning

Pharmacogenetic Test, Informed Consent, Indication

Datatyp

text

Alias
UMLS CUI [1,1]
C0031325
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0392360
Blood Sample Collection (DNA)
Beskrivning

Blood Sample Collection (DNA)

Alias
UMLS CUI-1
C2347500
UMLS CUI-2
C0005834
UMLS CUI-3
C0012854
Has a blood sample been collected for PGx-pharmacogenetic research?
Beskrivning

Pharmacogenetic Test, Collection of blood specimen for laboratory procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0005834
If Yes, record the date sample taken
Beskrivning

Pharmacogenetic Test, Collection of blood specimen for laboratory procedure, Date in time

Datatyp

date

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0005834
UMLS CUI [1,3]
C0011008
Withdrawal of Consent
Beskrivning

Withdrawal of Consent

Alias
UMLS CUI-1
C2347500
UMLS CUI-2
C0021430
UMLS CUI-3
C2349954
Has subject withdrawn consent for PGx-Pharmacogenetic research?
Beskrivning

Pharmacogenetic Test, Informed Consent, Withdraw

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C2349954
Blood Sample Destruction
Beskrivning

Blood Sample Destruction

Alias
UMLS CUI-1
C2347500
UMLS CUI-2
C0178913
UMLS CUI-3
C1948029
Has a request been made for sample destruction?
Beskrivning

Pharmacogenetic Test, Blood specimen, Destruction, Request

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1948029
UMLS CUI [1,4]
C1272683
If Yes, tick one reason
Beskrivning

Pharmacogenetic Test, Blood specimen, Destruction, Reason

Datatyp

text

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1948029
UMLS CUI [1,4]
C3146298
Tillbaka till toppen

Similar models

PGx-Pharmacogenetic Research

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item Group
Consent for PGx-Pharmacogenetic Research
C2347500 (UMLS CUI-1)
C0021430 (UMLS CUI-2)
Pharmacogenetic Test, Informed Consent
Item
Has informed consent been obtained for PGx-Pharmacogenetic research?
boolean
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
Pharmacogenetic Test, Informed Consent, Date in time
Item
If Yes, record the date informed consent obtained for PGx-Pharmacogenetic research
date
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
IfNo, tick one reason
text
C0031325 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Pharmacogenetic Test, Informed Consent, Indication
Code List
IfNo, tick one reason
CL Item
Subject declined (1)
CL Item
Subject not asked by Investigator (2)
CL Item
Other (3)
Item Group
Blood Sample Collection (DNA)
C2347500 (UMLS CUI-1)
C0005834 (UMLS CUI-2)
C0012854 (UMLS CUI-3)
Pharmacogenetic Test, Collection of blood specimen for laboratory procedure
Item
Has a blood sample been collected for PGx-pharmacogenetic research?
boolean
C2347500 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
Pharmacogenetic Test, Collection of blood specimen for laboratory procedure, Date in time
Item
If Yes, record the date sample taken
date
C2347500 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item Group
Withdrawal of Consent
C2347500 (UMLS CUI-1)
C0021430 (UMLS CUI-2)
C2349954 (UMLS CUI-3)
Pharmacogenetic Test, Informed Consent, Withdraw
Item
Has subject withdrawn consent for PGx-Pharmacogenetic research?
boolean
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,3])
Item Group
Blood Sample Destruction
C2347500 (UMLS CUI-1)
C0178913 (UMLS CUI-2)
C1948029 (UMLS CUI-3)
Pharmacogenetic Test, Blood specimen, Destruction, Request
Item
Has a request been made for sample destruction?
boolean
C2347500 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C1272683 (UMLS CUI [1,4])
Item
If Yes, tick one reason
text
C2347500 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C3146298 (UMLS CUI [1,4])
Pharmacogenetic Test, Blood specimen, Destruction, Reason
Code List
If Yes, tick one reason
CL Item
Subject requested  (1)
CL Item
Screen failure (2)
CL Item
Other (3)
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial