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
Mots-clés
Versions (3)
- 03/12/2018 03/12/2018 -
- 14/12/2018 14/12/2018 -
- 09/01/2019 09/01/2019 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
14 décembre 2018
DOI
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Licence
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
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0242485
- UMLS CUI [1,2]
- C0518766
- UMLS CUI [1,3]
- C3854240
Description
Staff initials
Type de données
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)
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0450973
- UMLS CUI [1,2]
- C1718255
Description
Reason for Assessment Specification
Type de données
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
Type de données
text
Alias
- UMLS CUI [1]
- C1948053
Description
If assessment is a repeat of a scheduled time point please specify
Type de données
text
Alias
- UMLS CUI [1]
- C2826182
Description
If assessment is a repeat of a scheduled time point please specify
Type de données
text
Alias
- UMLS CUI [1]
- C2348792
Description
Date of Assessment
Type de données
date
Alias
- UMLS CUI [1]
- C2985720
Description
Actual Time
Type de données
time
Alias
- UMLS CUI [1]
- C0040223
Description
Position of Measurement
Type de données
text
Alias
- UMLS CUI [1,1]
- C2963216
- UMLS CUI [1,2]
- C1262869
Description
Other Position of Measurement Specification
Type de données
text
Alias
- UMLS CUI [1,1]
- C2963216
- UMLS CUI [1,2]
- C1262869
- UMLS CUI [1,3]
- C2348235
Description
Pulse Rate
Type de données
integer
Unités de mesure
- bpm
Alias
- UMLS CUI [1]
- C0232117
Description
Systolic Blood Pressure
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
Diastolic Blood Pressure
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
Oral Body Temperature
Type de données
float
Unités de mesure
- °C
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C0442027
Description
Respiration Rate
Type de données
integer
Unités de mesure
- breaths/min
Alias
- UMLS CUI [1]
- C0231832
Description
Second Position
Alias
- UMLS CUI-1
- C0733755
- UMLS CUI-2
- C0205436
Description
Actual Time
Type de données
time
Alias
- UMLS CUI [1]
- C0040223
Description
Position of Measurement
Type de données
text
Alias
- UMLS CUI [1,1]
- C2963216
- UMLS CUI [1,2]
- C1262869
Description
Pulse Rate
Type de données
integer
Unités de mesure
- bpm
Alias
- UMLS CUI [1]
- C0232117
Description
Systolic Blood Pressure
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
Diastolic Blood Pressure
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
Conclusion
Alias
- UMLS CUI-1
- C1707478
Similar models
Unscheduled Vital Signs
- StudyEvent: ODM
C0600091 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
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])
C0871685 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])