ID

29785

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 Week 6 - Visit 8.

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

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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

Week 6 - Visit 8

1 Formulieren  
  1. StudyEvent: ODM
    1. Week 6 - Visit 8
Vital Signs
Beschrijving

Vital Signs

Alias
UMLS CUI-1
C0518766
Date
Beschrijving

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

Datatype

date

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

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

Datatype

integer

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

Systolic Blood Pressure

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Beschrijving

Diastolic Blood Pressure

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Beschrijving

Heart rate

Datatype

integer

Maateenheden
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Weight
Beschrijving

Weight

Datatype

float

Maateenheden
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Pregnancy Test
Beschrijving

Pregnancy Test

Alias
UMLS CUI-1
C0430056
Is a pregnancy test applicable?
Beschrijving

Pregnancy test applicable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C1706839
If a pregnancy test is applicable, was it performed?
Beschrijving

Pregnancy test performed

Datatype

boolean

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0884358
If a pregnancy test was performed, what was the result?
Beschrijving

If positive, complete PREGNANCY NOTIFICATION FORM.

Datatype

text

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C1274040
Psychiatric Evaluation
Beschrijving

Psychiatric Evaluation

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

Positive and Negative Syndrome Scale (PANSS)

Datatype

integer

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

Clinicians Global Impressions - Severity (CGI-S)

Datatype

integer

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

Clinicians Global Impressions - Improvement (CGI-I)

Datatype

integer

Alias
UMLS CUI [1]
C3639888
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Similar models

Week 6 - Visit 8

1 Formulieren
  1. StudyEvent: ODM
    1. Week 6 - Visit 8
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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
integer
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
Pregnancy Test
C0430056 (UMLS CUI-1)
Pregnancy test applicable
Item
Is a pregnancy test applicable?
boolean
C0032976 (UMLS CUI [1,1])
C1706839 (UMLS CUI [1,2])
Pregnancy test performed
Item
If a pregnancy test is applicable, was it performed?
boolean
C0032976 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
Item
If a pregnancy test was performed, what was the result?
text
C0032976 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Pregnancy Test Result
Code List
If a pregnancy test was performed, what was the result?
CL Item
positive (positive)
CL Item
negative (negative)
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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