ID
33590
Description
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 informations about measurements of any additional vital signs, not scheduled in the vital signs form. It should be checked at the screening visit, each treatment period and the follow-up visit. 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
Keywords
Versions (3)
- 12/3/18 12/3/18 -
- 12/14/18 12/14/18 -
- 1/9/19 1/9/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
December 14, 2018
DOI
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License
Creative Commons BY-NC 3.0
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Effect of Lamictal on Resting Motor Threshold Study-ID 107434
Unscheduled Vital Signs
- StudyEvent: ODM
Description
Unscheduled Vital Signs Conducted
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C3854240
Description
Measurement of Unscheduled Vital Signs
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0242485
- UMLS CUI [1,2]
- C0518766
- UMLS CUI [1,3]
- C3854240
Description
Staff initials
Data type
text
Alias
- UMLS CUI [1,1]
- C2986440
- UMLS CUI [1,2]
- C1552089
Description
Unscheduled Vital Signs
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C3854240
Description
(See key code below) Key Code: 1. Outside of reference range 2. Protocol requirement 3. Physician request (Specify) 4. Adverse event (Specify) 5. Other (Specify)
Data type
integer
Alias
- UMLS CUI [1,1]
- C0450973
- UMLS CUI [1,2]
- C1718255
Description
Reason for Assessment Specification
Data type
integer
Alias
- UMLS CUI [1,1]
- C0450973
- UMLS CUI [1,2]
- C1718255
- UMLS CUI [1,3]
- C2348235
Description
If assessment is a repeat of a scheduled time point please specify
Data type
text
Alias
- UMLS CUI [1]
- C1948053
Description
If assessment is a repeat of a scheduled time point please specify
Data type
text
Alias
- UMLS CUI [1]
- C2826182
Description
If assessment is a repeat of a scheduled time point please specify
Data type
text
Alias
- UMLS CUI [1]
- C2348792
Description
Date of Assessment
Data type
date
Alias
- UMLS CUI [1]
- C2985720
Description
Actual Time
Data type
time
Alias
- UMLS CUI [1]
- C0040223
Description
Position of Measurement
Data type
text
Alias
- UMLS CUI [1,1]
- C2963216
- UMLS CUI [1,2]
- C1262869
Description
Other Position of Measurement Specification
Data type
text
Alias
- UMLS CUI [1,1]
- C2963216
- UMLS CUI [1,2]
- C1262869
- UMLS CUI [1,3]
- C2348235
Description
Pulse Rate
Data type
integer
Measurement units
- bpm
Alias
- UMLS CUI [1]
- C0232117
Description
Systolic Blood Pressure
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
Diastolic Blood Pressure
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
Oral Body Temperature
Data type
float
Measurement units
- °C
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C0442027
Description
Respiration Rate
Data type
integer
Measurement units
- breaths/min
Alias
- UMLS CUI [1]
- C0231832
Description
Second Position
Alias
- UMLS CUI-1
- C0733755
- UMLS CUI-2
- C0205436
Description
Actual Time
Data type
time
Alias
- UMLS CUI [1]
- C0040223
Description
Position of Measurement
Data type
text
Alias
- UMLS CUI [1,1]
- C2963216
- UMLS CUI [1,2]
- C1262869
Description
Pulse Rate
Data type
integer
Measurement units
- bpm
Alias
- UMLS CUI [1]
- C0232117
Description
Systolic Blood Pressure
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
Diastolic Blood Pressure
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
Conclusion
Alias
- UMLS CUI-1
- C1707478
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Unscheduled Vital Signs
- StudyEvent: ODM
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C3854240 (UMLS CUI-2)
C0518766 (UMLS CUI [1,2])
C3854240 (UMLS CUI [1,3])
C1552089 (UMLS CUI [1,2])
C3854240 (UMLS CUI-2)
C1718255 (UMLS CUI [1,2])
C1718255 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C1262869 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0442027 (UMLS CUI [1,2])
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