ID

33452

Beskrivning

Study ID: 107434 Clinical Study ID: NAP107434 Study Title: A randomised, double-blind, double-dummy, placebo controlled, three-way cross-over study to investigate the effect of single oral doses of 100 mg GW273225 (4030W92) and 325 mg LAMICTAL on resting motor threshold in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Study Link: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW273225 Trade Name: lamictal Study Indication: Bipolar Disorder This form contains the result of the physical examination. It should be filled out at screening visit and updated throughout the study if necessary. Screening Visit: 28 days prior to first dosing. Treatment Period: The day before dosing, until 48h after dosing. Follow-Up: 14-21 days after last dose

Nyckelord

Versioner (3)
  1. 2018-12-01 2018-12-01 -
  2. 2018-12-09 2018-12-09 -
  3. 2018-12-18 2018-12-18 - Sarah Riepenhausen
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

9 december 2018

DOI

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Creative Commons BY-NC 3.0
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Effect of Lamictal on Resting Motor Threshold Study-ID 107434

Engelsk

Physical Examination

1 Formulär  
  1. StudyEvent: ODM
    1. Physical Examination
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Screening number
Beskrivning

Subject Screening No.

Datatyp

integer

Alias
UMLS CUI [1,1]
C0220908
UMLS CUI [1,2]
C0600091
Subject no.
Beskrivning

Subject Number

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Date Information Collected
Beskrivning

Date Information Collected

Datatyp

date

Alias
UMLS CUI [1,1]
C3244127
UMLS CUI [1,2]
C0011008
Physical Examination
Beskrivning

Physical Examination

Alias
UMLS CUI-1
C0031809
Examination
Beskrivning

Examination

Datatyp

text

Alias
UMLS CUI [1]
C0031809
Examination Result
Beskrivning

Examination Result

Datatyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C1274040
If abnormal please describe
Beskrivning

Examination Result Abnormal

Datatyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C0205161
Examination Result Clinically Significant
Beskrivning

Examination Result Clinically Significant

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0459424
UMLS CUI [1,2]
C2826634
Is the subject healthy as determined by the clinical examination?
Beskrivning

Subject Healthy

Datatyp

boolean

Alias
UMLS CUI [1]
C3898900
Conclusion
Beskrivning

Conclusion

Alias
UMLS CUI-1
C1707478
Staff initials
Beskrivning

Staff initials

Datatyp

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C1552089
Physician's Initials
Beskrivning

Physician's Initials

Datatyp

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C0031831
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Similar models

Physical Examination

1 Formulär
  1. StudyEvent: ODM
    1. Physical Examination
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Screening No.
Item
Subject Screening number
integer
C0220908 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Subject Number
Item
Subject no.
integer
C2348585 (UMLS CUI [1])
Date Information Collected
Item
Date Information Collected
date
C3244127 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Physical Examination
C0031809 (UMLS CUI-1)
Item
Examination
text
C0031809 (UMLS CUI [1])
Examination Area
Code List
Examination
CL Item
HEENT (HEENT)
CL Item
Cardiovascular (Cardiovascular)
CL Item
Chest/Lungs (Chest/Lungs)
CL Item
Abdomen (Abdomen)
CL Item
Neurological (Neurological)
CL Item
Musculoskeletal (Musculoskeletal)
CL Item
Fundoscopy (Fundoscopy)
CL Item
Lymph (Lymph)
CL Item
Nodes (Nodes)
CL Item
Other (Other)
CL Item
General appearance (General appearance)
CL Item
Neck and Thyroid (Neck and Thyroid)
CL Item
Skin (incl. hair, nails) (Skin (incl. hair, nails))
Item
Examination Result
text
C0031809 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Examination Result
Code List
Examination Result
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
CL Item
Not done (Not done)
Examination Result Abnormal
Item
If abnormal please describe
text
C0031809 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
Examination Result Clinically Significant
Item
Examination Result Clinically Significant
boolean
C0459424 (UMLS CUI [1,1])
C2826634 (UMLS CUI [1,2])
Subject Healthy
Item
Is the subject healthy as determined by the clinical examination?
boolean
C3898900 (UMLS CUI [1])
Item Group
Conclusion
C1707478 (UMLS CUI-1)
Staff initials
Item
Staff initials
text
C2986440 (UMLS CUI [1,1])
C1552089 (UMLS CUI [1,2])
Physician's Initials
Item
Physician's Initials
text
C2986440 (UMLS CUI [1,1])
C0031831 (UMLS CUI [1,2])
Tillbaka till toppen 

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