ID

44094

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 14 - Visit 12: End of Down Titration.

Link

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

Keywords

Versions (2)
  1. 4/19/18 4/19/18 - Sarah Riepenhausen
  2. 9/20/21 9/20/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 20, 2021

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 14 - Visit 12: End of Down Titration

1 forms  
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
Physical Examination
Description

Physical Examination

Alias
UMLS CUI-1
C0031809
Hair and skin
Description

Hair and skin

Data type

text

Alias
UMLS CUI [1,1]
C0018494
UMLS CUI [1,2]
C0558035
Hair and Skin: If Abnormal, please specify
Description

Hair and Skin

Data type

text

Alias
UMLS CUI [1,1]
C0018494
UMLS CUI [1,2]
C0558035
UMLS CUI [1,3]
C1704258
Lymph nodes
Description

Lymph nodes

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0024204
Lymph nodes: If Abnormal, please specify
Description

Lymph nodes

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0024204
UMLS CUI [1,3]
C1704258
Eyes
Description

Eyes

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0200149
Eyes: If Abnormal, please specify
Description

Eyes

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0200149
UMLS CUI [1,3]
C1704258
Ears, Nose and Throat
Description

Ears, Nose and Throat

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0278350
Ears, Nose and Throat: If Abnormal, please specify
Description

Ears, Nose and Throat

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0278350
UMLS CUI [1,3]
C1704258
Breasts
Description

Breasts

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0199850
Breasts: If Abnormal, please specify
Description

Breasts

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0199850
UMLS CUI [1,3]
C1704258
Respiratory
Description

Respiratory

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0436121
Respiratory: If Abnormal, please specify
Description

Respiratory

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0436121
UMLS CUI [1,3]
C1704258
Cardiovascular
Description

Cardiovascular

Data type

text

Alias
UMLS CUI [1]
C3854344
Cardiovascular: If Abnormal, please specify
Description

Cardiovascular

Data type

text

Alias
UMLS CUI [1,1]
C3854344
UMLS CUI [1,2]
C1704258
Abdomen
Description

Abdomen

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0000726
Abdomen: If Abnormal, please specify
Description

Abdomen

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0000726
UMLS CUI [1,3]
C1704258
Urogenital
Description

Urogenital

Data type

text

Alias
UMLS CUI [1]
C1828035
Urogenital: If abnormal, please specify
Description

Urogenital

Data type

text

Alias
UMLS CUI [1,1]
C1828035
UMLS CUI [1,2]
C1704258
Pelvic
Description

Pelvic

Data type

text

Alias
UMLS CUI [1]
C0200045
Pelvic: If Abnormal, please specify
Description

Pelvic

Data type

text

Alias
UMLS CUI [1,1]
C0200045
UMLS CUI [1,2]
C1704258
Rectal
Description

Rectal

Data type

text

Alias
UMLS CUI [1]
C0199900
Rectal: If abnormal, please specify
Description

Rectal

Data type

text

Alias
UMLS CUI [1,1]
C0199900
UMLS CUI [1,2]
C1704258
Musculoskeletal
Description

Musculoskeletal

Data type

text

Alias
UMLS CUI [1]
C0475091
Musculoskeletal: If Abnormal, please specify
Description

Musculoskeletal

Data type

text

Alias
UMLS CUI [1,1]
C0475091
UMLS CUI [1,2]
C1704258
Neurological
Description

Neurological

Data type

text

Alias
UMLS CUI [1]
C0027853
Neurological: If Abnormal, please specify
Description

Neurological

Data type

text

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C1704258
Mental status
Description

Mental status

Data type

text

Alias
UMLS CUI [1]
C3260990
Mental Status: If Abnormal, please specify
Description

Mental Status

Data type

text

Alias
UMLS CUI [1,1]
C3260990
UMLS CUI [1,2]
C1704258
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Similar models

Week 14 - Visit 12: End of Down Titration

1 forms
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
Physical Examination
C0031809 (UMLS CUI-1)
Item
Hair and skin
text
C0018494 (UMLS CUI [1,1])
C0558035 (UMLS CUI [1,2])
Hair and skin
Code List
Hair and skin
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Hair and Skin
Item
Hair and Skin: If Abnormal, please specify
text
C0018494 (UMLS CUI [1,1])
C0558035 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
Item
Lymph nodes
text
C0031809 (UMLS CUI [1,1])
C0024204 (UMLS CUI [1,2])
Hair and skin
Code List
Lymph nodes
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Lymph nodes
Item
Lymph nodes: If Abnormal, please specify
text
C0031809 (UMLS CUI [1,1])
C0024204 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
Item
Eyes
text
C0031809 (UMLS CUI [1,1])
C0200149 (UMLS CUI [1,2])
Hair and skin
Code List
Eyes
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Eyes
Item
Eyes: If Abnormal, please specify
text
C0031809 (UMLS CUI [1,1])
C0200149 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
Item
Ears, Nose and Throat
text
C0031809 (UMLS CUI [1,1])
C0278350 (UMLS CUI [1,2])
Hair and skin
Code List
Ears, Nose and Throat
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Ears, Nose and Throat
Item
Ears, Nose and Throat: If Abnormal, please specify
text
C0031809 (UMLS CUI [1,1])
C0278350 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
Item
Breasts
text
C0031809 (UMLS CUI [1,1])
C0199850 (UMLS CUI [1,2])
Breasts
Code List
Breasts
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
CL Item
Not Done (Not Done)
Breasts
Item
Breasts: If Abnormal, please specify
text
C0031809 (UMLS CUI [1,1])
C0199850 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
Item
Respiratory
text
C0031809 (UMLS CUI [1,1])
C0436121 (UMLS CUI [1,2])
Hair and skin
Code List
Respiratory
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Respiratory
Item
Respiratory: If Abnormal, please specify
text
C0031809 (UMLS CUI [1,1])
C0436121 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
Item
Cardiovascular
text
C3854344 (UMLS CUI [1])
Hair and skin
Code List
Cardiovascular
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Cardiovascular
Item
Cardiovascular: If Abnormal, please specify
text
C3854344 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Item
Abdomen
text
C0031809 (UMLS CUI [1,1])
C0000726 (UMLS CUI [1,2])
Hair and skin
Code List
Abdomen
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Abdomen
Item
Abdomen: If Abnormal, please specify
text
C0031809 (UMLS CUI [1,1])
C0000726 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
Item
Urogenital
text
C1828035 (UMLS CUI [1])
Urogenital
Code List
Urogenital
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
CL Item
Not Done (Not Done)
Urogenital
Item
Urogenital: If abnormal, please specify
text
C1828035 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Item
Pelvic
text
C0200045 (UMLS CUI [1])
Breasts
Code List
Pelvic
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
CL Item
Not Done (Not Done)
Pelvic
Item
Pelvic: If Abnormal, please specify
text
C0200045 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Item
Rectal
text
C0199900 (UMLS CUI [1])
Breasts
Code List
Rectal
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
CL Item
Not Done (Not Done)
Rectal
Item
Rectal: If abnormal, please specify
text
C0199900 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Item
Musculoskeletal
text
C0475091 (UMLS CUI [1])
Lymph nodes
Code List
Musculoskeletal
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Musculoskeletal
Item
Musculoskeletal: If Abnormal, please specify
text
C0475091 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Item
Neurological
text
C0027853 (UMLS CUI [1])
Hair and skin
Code List
Neurological
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Neurological
Item
Neurological: If Abnormal, please specify
text
C0027853 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Item
Mental status
text
C3260990 (UMLS CUI [1])
Hair and skin
Code List
Mental status
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Mental Status
Item
Mental Status: If Abnormal, please specify
text
C3260990 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
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