ID

29775

Beschreibung

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

Stichworte

Versionen (1)
  1. 19.04.18 19.04.18 - Sarah Riepenhausen
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

19. April 2018

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY-NC 3.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Evaluation of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive to Atypical Antipsychotic Agents in Schizophrenia NCT00086593

Englisch

Screen Part 3: Physical Examination and Vital signs

1 Formulare  
Physical examination
Beschreibung

Physical examination

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

Hair and Skin

Datentyp

text

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

Hair and Skin

Datentyp

text

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

Lymph Nodes

Datentyp

text

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

Lymph Nodes

Datentyp

text

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

Eyes

Datentyp

text

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

Eyes

Datentyp

text

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

Ears, nose and throat

Datentyp

text

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

Ears, nose and throat

Datentyp

text

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

Breasts

Datentyp

text

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

Breasts

Datentyp

text

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

Respiratory

Datentyp

text

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

Respiratory

Datentyp

text

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

Cardiovascular

Datentyp

text

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

Cardiovascular

Datentyp

text

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

Abdomen

Datentyp

text

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

Abdomen

Datentyp

text

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

Urogenital

Datentyp

text

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

Urogenital

Datentyp

text

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

Pelvic

Datentyp

text

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

Pelvic

Datentyp

text

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

Rectal

Datentyp

text

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

Rectal

Datentyp

text

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

Musculoskeletal

Datentyp

text

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

Musculoskeletal

Datentyp

text

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

Neurological

Datentyp

text

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

Neurological

Datentyp

text

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

Mental Status

Datentyp

text

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

Mental Status

Datentyp

text

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

Vital Signs

Alias
UMLS CUI-1
C0518766
Date
Beschreibung

Date

Datentyp

date

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

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

Datentyp

integer

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

Systolic Blood Pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Beschreibung

Diastolic Blood Pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Beschreibung

Heart rate

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Height
Beschreibung

Height

Datentyp

integer

Maßeinheiten
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Beschreibung

Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Screen Part 3: Physical Examination and Vital signs

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video