ID

29793

Descripción

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

Palabras clave

Versiones (1)
  1. 19/4/18 19/4/18 - Sarah Riepenhausen
Titular de derechos de autor

GlaxoSmithKline

Subido en

19 de abril de 2018

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

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

Inglés

Pharmacogenetic Research

1 formularios  
Consent for Pharmacogenetic Research
Descripción

Consent for Pharmacogenetic Research

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

Informed consent for Pharmacogenetic Research

Tipo de datos

text

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

Date of informed consent for pharmacogenetic research

Tipo de datos

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:
Descripción

Reason for no consent for pharmacogenetic research

Tipo de datos

text

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

Blood sample collection

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

Blood sample for Pharmacogenetic Research

Tipo de datos

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:
Descripción

Date sample taken

Tipo de datos

date

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

Withdrawal of consent

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Has this subject withdrawn consent for Pharmacogenetic Research?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

Withdrawal of consent

Tipo de datos

text

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

Blood Sample Destruction

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

Request for Blood Sample Destruction

Tipo de datos

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?
Descripción

Reason for Blood sample Destruction

Tipo de datos

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 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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