ID

29775

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 Screen Part 3: Physical Examination and Vital signs.

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

Screen Part 3: Physical Examination and Vital signs

1 Formulieren  
Physical examination
Beschrijving

Physical examination

Alias
UMLS CUI-1
C0031809
Physical findings: Hair and Skin
Beschrijving

Hair and Skin

Datatype

text

Alias
UMLS CUI [1,1]
C0018494
UMLS CUI [1,2]
C0558035
Hair and Skin: If abnormal physical findings, specify:
Beschrijving

Hair and Skin

Datatype

text

Alias
UMLS CUI [1,1]
C0018494
UMLS CUI [1,2]
C0558035
UMLS CUI [1,3]
C1704258
Physical Findings: Lymph Nodes
Beschrijving

Lymph Nodes

Datatype

text

Alias
UMLS CUI [1]
C0024204
Lymph Nodes: If abnormal physical findings, specify:
Beschrijving

Lymph Nodes

Datatype

text

Alias
UMLS CUI [1,1]
C0024204
UMLS CUI [1,2]
C1704258
Physical Findings: Eyes
Beschrijving

Eyes

Datatype

text

Alias
UMLS CUI [1,1]
C0015392
UMLS CUI [1,2]
C0031809
Eyes: If abnormal physical findings, specify:
Beschrijving

Eyes

Datatype

text

Alias
UMLS CUI [1,1]
C0015392
UMLS CUI [1,2]
C0031809
UMLS CUI [1,3]
C1704258
Physical Findings: Ears, nose and throat
Beschrijving

Ears, nose and throat

Datatype

text

Alias
UMLS CUI [1]
C0278350
Ears, nose and throat: If abnormal physical findings, specify:
Beschrijving

Ears, nose and throat

Datatype

text

Alias
UMLS CUI [1,1]
C0278350
UMLS CUI [1,2]
C1704258
Physical Findings: Breasts
Beschrijving

Breasts

Datatype

text

Alias
UMLS CUI [1]
C0199850
Breasts: If abnormal physical findings, specify:
Beschrijving

Breasts

Datatype

text

Alias
UMLS CUI [1,1]
C0199850
UMLS CUI [1,2]
C1704258
Physical findings: Respiratory
Beschrijving

Respiratory

Datatype

text

Alias
UMLS CUI [1,1]
C0035237
UMLS CUI [1,2]
C0031809
Respiratory: If abnormal physical findings, specify:
Beschrijving

Respiratory

Datatype

text

Alias
UMLS CUI [1,1]
C0035237
UMLS CUI [1,2]
C0031809
UMLS CUI [1,3]
C1704258
Physical findings: cardiovascular
Beschrijving

Cardiovascular

Datatype

text

Alias
UMLS CUI [1]
C3854344
Cardiovascular: If abnormal physical findings, specify:
Beschrijving

Cardiovascular

Datatype

text

Alias
UMLS CUI [1,1]
C3854344
UMLS CUI [1,2]
C1704258
Physical Findings: Abdomen
Beschrijving

Abdomen

Datatype

text

Alias
UMLS CUI [1]
C0562238
Abdomen: If abnormal physical findings, specify:
Beschrijving

Abdomen

Datatype

text

Alias
UMLS CUI [1,1]
C0562238
UMLS CUI [1,2]
C1704258
Physical Findings: Urogenital
Beschrijving

Urogenital

Datatype

text

Alias
UMLS CUI [1]
C1828035
Urogenital: If abnormal physical findings, specify:
Beschrijving

Urogenital

Datatype

text

Alias
UMLS CUI [1,1]
C1828035
UMLS CUI [1,2]
C1704258
Physical Findings: Pelvic
Beschrijving

Pelvic

Datatype

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0030797
Pelvic: If abnormal physical findings, specify:
Beschrijving

Pelvic

Datatype

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0030797
UMLS CUI [1,3]
C1704258
Physical findings: Rectal
Beschrijving

Rectal

Datatype

text

Alias
UMLS CUI [1]
C0199900
Rectal: If abnormal physical findings, specify:
Beschrijving

Rectal

Datatype

text

Alias
UMLS CUI [1,1]
C0199900
UMLS CUI [1,2]
C1704258
Physical Findings: Musculoskeletal
Beschrijving

Musculoskeletal

Datatype

text

Alias
UMLS CUI [1]
C0475091
Musculoskeletal: If abnormal physical findings, specify:
Beschrijving

Musculoskeletal

Datatype

text

Alias
UMLS CUI [1,1]
C0475091
UMLS CUI [1,2]
C1704258
Physical findings: Neurological
Beschrijving

Neurological

Datatype

text

Alias
UMLS CUI [1]
C0027853
Neurological: If abnormal physical findings, specify:
Beschrijving

Neurological

Datatype

text

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C1704258
Mental Status
Beschrijving

Mental Status

Datatype

text

Alias
UMLS CUI [1]
C0278060
Mental Status: If abnormal, specify:
Beschrijving

Mental Status

Datatype

text

Alias
UMLS CUI [1,1]
C0278060
UMLS CUI [1,2]
C1704258
Vital Signs
Beschrijving

Vital Signs

Alias
UMLS CUI-1
C0518766
Date
Beschrijving

Date

Datatype

date

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

Record both: 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
Height
Beschrijving

Height

Datatype

integer

Maateenheden
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Beschrijving

Weight

Datatype

float

Maateenheden
  • kg
Alias
UMLS CUI [1]
C0005910
kg
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Similar models

Screen Part 3: Physical Examination and Vital signs

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Physical examination
C0031809 (UMLS CUI-1)
Item
Physical findings: Hair and Skin
text
C0018494 (UMLS CUI [1,1])
C0558035 (UMLS CUI [1,2])
Hair and Skin
Code List
Physical findings: Hair and Skin
CL Item
normal (normal)
CL Item
abnormal (abnormal)
Item
Hair and Skin: If abnormal physical findings, specify:
text
C0018494 (UMLS CUI [1,1])
C0558035 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
Hair and Skin
Code List
Hair and Skin: If abnormal physical findings, specify:
Item
Physical Findings: Lymph Nodes
text
C0024204 (UMLS CUI [1])
Hair and Skin
Code List
Physical Findings: Lymph Nodes
CL Item
normal (normal)
CL Item
abnormal (abnormal)
Lymph Nodes
Item
Lymph Nodes: If abnormal physical findings, specify:
text
C0024204 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Item
Physical Findings: Eyes
text
C0015392 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
Hair and Skin
Code List
Physical Findings: Eyes
CL Item
normal (normal)
CL Item
abnormal (abnormal)
Item
Eyes: If abnormal physical findings, specify:
text
C0015392 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
Hair and Skin
Code List
Eyes: If abnormal physical findings, specify:
Item
Physical Findings: Ears, nose and throat
text
C0278350 (UMLS CUI [1])
Hair and Skin
Code List
Physical Findings: Ears, nose and throat
CL Item
normal (normal)
CL Item
abnormal (abnormal)
Ears, nose and throat
Item
Ears, nose and throat: If abnormal physical findings, specify:
text
C0278350 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Item
Physical Findings: Breasts
text
C0199850 (UMLS CUI [1])
Breasts
Code List
Physical Findings: Breasts
CL Item
normal (normal)
CL Item
abnormal (abnormal)
CL Item
not done (not done)
Breasts
Item
Breasts: If abnormal physical findings, specify:
text
C0199850 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Item
Physical findings: Respiratory
text
C0035237 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
Hair and Skin
Code List
Physical findings: Respiratory
CL Item
normal (normal)
CL Item
abnormal (abnormal)
Item
Respiratory: If abnormal physical findings, specify:
text
C0035237 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
Hair and Skin
Code List
Respiratory: If abnormal physical findings, specify:
Item
Physical findings: cardiovascular
text
C3854344 (UMLS CUI [1])
Hair and Skin
Code List
Physical findings: cardiovascular
CL Item
normal (normal)
CL Item
abnormal (abnormal)
Cardiovascular
Item
Cardiovascular: If abnormal physical findings, specify:
text
C3854344 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Item
Physical Findings: Abdomen
text
C0562238 (UMLS CUI [1])
Hair and Skin
Code List
Physical Findings: Abdomen
CL Item
normal (normal)
CL Item
abnormal (abnormal)
Item
Abdomen: If abnormal physical findings, specify:
text
C0562238 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Hair and Skin
Code List
Abdomen: If abnormal physical findings, specify:
Item
Physical Findings: Urogenital
text
C1828035 (UMLS CUI [1])
Breasts
Code List
Physical Findings: Urogenital
CL Item
normal (normal)
CL Item
abnormal (abnormal)
CL Item
not done (not done)
Item
Urogenital: If abnormal physical findings, specify:
text
C1828035 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Hair and Skin
Code List
Urogenital: If abnormal physical findings, specify:
Item
Physical Findings: Pelvic
text
C0031809 (UMLS CUI [1,1])
C0030797 (UMLS CUI [1,2])
Breasts
Code List
Physical Findings: Pelvic
CL Item
normal (normal)
CL Item
abnormal (abnormal)
CL Item
not done (not done)
Pelvic
Item
Pelvic: If abnormal physical findings, specify:
text
C0031809 (UMLS CUI [1,1])
C0030797 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
Item
Physical findings: Rectal
text
C0199900 (UMLS CUI [1])
Breasts
Code List
Physical findings: Rectal
CL Item
normal (normal)
CL Item
abnormal (abnormal)
CL Item
not done (not done)
Rectal
Item
Rectal: If abnormal physical findings, specify:
text
C0199900 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Item
Physical Findings: Musculoskeletal
text
C0475091 (UMLS CUI [1])
Hair and Skin
Code List
Physical Findings: Musculoskeletal
CL Item
normal (normal)
CL Item
abnormal (abnormal)
Musculoskeletal
Item
Musculoskeletal: If abnormal physical findings, specify:
text
C0475091 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Item
Physical findings: Neurological
text
C0027853 (UMLS CUI [1])
Hair and Skin
Code List
Physical findings: Neurological
CL Item
normal (normal)
CL Item
abnormal (abnormal)
Item
Neurological: If abnormal physical findings, specify:
text
C0027853 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Hair and Skin
Code List
Neurological: If abnormal physical findings, specify:
Item
Mental Status
text
C0278060 (UMLS CUI [1])
Hair and Skin
Code List
Mental Status
CL Item
normal (normal)
CL Item
abnormal (abnormal)
Item
Mental Status: If abnormal, specify:
text
C0278060 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Hair and Skin
Code List
Mental Status: If abnormal, specify:
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])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
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