ID

29793

Beschrijving

Study ID: 101464 Clinical Study ID: SCA101464 Study Title: A Multicenter, Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive Therapy to an Atypical Antipsychotic Agent(s) in Subjects with Schizophrenia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00086593 https://clinicaltrials.gov/ct2/show/NCT00086593 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Study Indication: Lamictal XR,Lamictal,LAMICTIN This ODM form contains Pharmacogenetic Research.

Link

https://clinicaltrials.gov/ct2/show/NCT00086593

Trefwoorden

Versies (1)
  1. 19-04-18 19-04-18 - Sarah Riepenhausen
Houder van rechten

GlaxoSmithKline

Geüploaded op

19 april 2018

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0
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Evaluation of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive to Atypical Antipsychotic Agents in Schizophrenia NCT00086593

Engels

Pharmacogenetic Research

1 Formulieren  
Consent for Pharmacogenetic Research
Beschrijving

Consent for Pharmacogenetic Research

Alias
UMLS CUI-1
C0021430
UMLS CUI-2
C2347500
Has informed consent been obtained for Pharmacogenetic Research?
Beschrijving

Informed consent for Pharmacogenetic Research

Datatype

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
If consent for pharmacogenetic research was obtained, give the date.
Beschrijving

Date of informed consent for pharmacogenetic research

Datatype

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C2347501
If no consent for pharmacogenetic research was obtained, specify the reason:
Beschrijving

Reason for no consent for pharmacogenetic research

Datatype

text

Alias
UMLS CUI [1,1]
C0031325
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0392360
Blood sample collection
Beschrijving

Blood sample collection

Alias
UMLS CUI-1
C0005834
UMLS CUI-2
C0031325
Has a blood sample been collected for Pharmacogenetic Research?
Beschrijving

Blood sample for Pharmacogenetic Research

Datatype

text

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0031325
If a blood sample has been taken for pharmacogenetic research, give a date:
Beschrijving

Date sample taken

Datatype

date

Alias
UMLS CUI [1,1]
C1302413
UMLS CUI [1,2]
C0031325
Withdrawal of consent
Beschrijving

Withdrawal of consent

Alias
UMLS CUI-1
C1707492
UMLS CUI-2
C0031325
Has this subject withdrawn consent for Pharmacogenetic Research?
Beschrijving

Withdrawal of consent

Datatype

text

Alias
UMLS CUI [1,1]
C1707492
UMLS CUI [1,2]
C0031325
Blood Sample Destruction
Beschrijving

Blood Sample Destruction

Alias
UMLS CUI-1
C1948029
UMLS CUI-2
C0178913
UMLS CUI-3
C0031325
Has a request been made for sample destruction?
Beschrijving

Request for Blood Sample Destruction

Datatype

text

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1272683
UMLS CUI [1,4]
C0031325
If a request has been made, what was the reason for blood sample destruction?
Beschrijving

Reason for Blood sample Destruction

Datatype

text

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C0031325
UMLS CUI [1,4]
C0392360
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Similar models

Pharmacogenetic Research

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Consent for Pharmacogenetic Research
C0021430 (UMLS CUI-1)
C2347500 (UMLS CUI-2)
Item
Has informed consent been obtained for Pharmacogenetic Research?
text
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
Informed consent for Pharmacogenetic Research
Code List
Has informed consent been obtained for Pharmacogenetic Research?
CL Item
yes (Y)
CL Item
no (N)
Date of informed consent for pharmacogenetic research
Item
If consent for pharmacogenetic research was obtained, give the date.
date
C0011008 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C2347501 (UMLS CUI [1,3])
Item
If no consent for pharmacogenetic research was obtained, specify the reason:
text
C0031325 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Reason for no consent for pharmacogenetic research
Code List
If no consent for pharmacogenetic research was obtained, specify the reason:
CL Item
Subject declined (SD)
CL Item
Subject not asked by investigator (SI)
CL Item
other (X)
Item Group
Blood sample collection
C0005834 (UMLS CUI-1)
C0031325 (UMLS CUI-2)
Item
Has a blood sample been collected for Pharmacogenetic Research?
text
C0005834 (UMLS CUI [1,1])
C0031325 (UMLS CUI [1,2])
Informed consent for Pharmacogenetic Research
Code List
Has a blood sample been collected for Pharmacogenetic Research?
CL Item
yes (Y)
CL Item
no (N)
Date sample taken
Item
If a blood sample has been taken for pharmacogenetic research, give a date:
date
C1302413 (UMLS CUI [1,1])
C0031325 (UMLS CUI [1,2])
Item Group
Withdrawal of consent
C1707492 (UMLS CUI-1)
C0031325 (UMLS CUI-2)
Item
Has this subject withdrawn consent for Pharmacogenetic Research?
text
C1707492 (UMLS CUI [1,1])
C0031325 (UMLS CUI [1,2])
Informed consent for Pharmacogenetic Research
Code List
Has this subject withdrawn consent for Pharmacogenetic Research?
CL Item
yes (Y)
CL Item
no (N)
Item Group
Blood Sample Destruction
C1948029 (UMLS CUI-1)
C0178913 (UMLS CUI-2)
C0031325 (UMLS CUI-3)
Item
Has a request been made for sample destruction?
text
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C0031325 (UMLS CUI [1,4])
Informed consent for Pharmacogenetic Research
Code List
Has a request been made for sample destruction?
CL Item
yes (Y)
CL Item
no (N)
Item
If a request has been made, what was the reason for blood sample destruction?
text
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0031325 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,4])
Reason for Blood sample Destruction
Code List
If a request has been made, what was the reason for blood sample destruction?
CL Item
Subject's request (R)
CL Item
Screen failure (F)
CL Item
other (X)
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