ID

29785

Description

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

Keywords

Versions (1)
  1. 4/19/18 4/19/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

April 19, 2018

DOI

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License

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

English

Week 6 - Visit 8

1 forms  
  1. StudyEvent: ODM
    1. Week 6 - Visit 8
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Date
Description

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

Data type

date

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

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

Data type

integer

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

Systolic Blood Pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Description

Diastolic Blood Pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Pregnancy Test
Description

Pregnancy Test

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

Pregnancy test applicable

Data type

boolean

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

Pregnancy test performed

Data type

boolean

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

If positive, complete PREGNANCY NOTIFICATION FORM.

Data type

text

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

Psychiatric Evaluation

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

Positive and Negative Syndrome Scale (PANSS)

Data type

integer

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

Clinicians Global Impressions - Severity (CGI-S)

Data type

integer

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

Clinicians Global Impressions - Improvement (CGI-I)

Data type

integer

Alias
UMLS CUI [1]
C3639888
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Similar models

Week 6 - Visit 8

1 forms
  1. StudyEvent: ODM
    1. Week 6 - Visit 8
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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