ID

29781

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 Week 2 - Visit 4.

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

Week 2 - Visit 4

1 formularios  
  1. StudyEvent: ODM
    1. Week 2 - Visit 4
Vital Signs
Descripción

Vital Signs

Alias
UMLS CUI-1
C0518766
Date
Descripción

If assessments are taken on 2 separate dates for this visit, the Visit Date is the first date the subject is seen.

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0518766
Subject Position
Descripción

Record both; record sitting heart rate and blood pressure prior to recording standing heart rate and blood pressure.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1262869
UMLS CUI [1,2]
C0518766
Systolic Blood Pressure
Descripción

Systolic Blood Pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Descripción

Diastolic Blood Pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Descripción

Heart rate

Tipo de datos

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Weight
Descripción

Weight

Tipo de datos

float

Unidades de medida
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Psychiatric Evaluation
Descripción

Psychiatric Evaluation

Alias
UMLS CUI-1
C0846574
Total Score in Positive and Negative Syndrome Scale (PANSS)
Descripción

Positive and Negative Syndrome Scale (PANSS)

Tipo de datos

integer

Alias
UMLS CUI [1]
C0451383
Score of Clinicians Global Impressions, Part Severity (CGI-S)
Descripción

Clinicians Global Impressions - Severity (CGI-S)

Tipo de datos

integer

Alias
UMLS CUI [1]
C3639887
Score of Clinicians Global Impressions, Part Improvement (CGI-I)
Descripción

Clinicians Global Impressions - Improvement (CGI-I)

Tipo de datos

integer

Alias
UMLS CUI [1]
C3639888
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Similar models

Week 2 - Visit 4

1 formularios
  1. StudyEvent: ODM
    1. Week 2 - Visit 4
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Date
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
Item
Subject Position
text
C1262869 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
Subject Position
Code List
Subject Position
CL Item
Sitting (1)
CL Item
Standing (2)
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
Psychiatric Evaluation
C0846574 (UMLS CUI-1)
Positive and Negative Syndrome Scale (PANSS)
Item
Total Score in Positive and Negative Syndrome Scale (PANSS)
integer
C0451383 (UMLS CUI [1])
Clinicians Global Impressions - Severity (CGI-S)
Item
Score of Clinicians Global Impressions, Part Severity (CGI-S)
integer
C3639887 (UMLS CUI [1])
Clinicians Global Impressions - Improvement (CGI-I)
Item
Score of Clinicians Global Impressions, Part Improvement (CGI-I)
integer
C3639888 (UMLS CUI [1])
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