ID
33590
Beschreibung
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
Stichworte
Versionen (3)
- 03.12.18 03.12.18 -
- 14.12.18 14.12.18 -
- 09.01.19 09.01.19 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
14. Dezember 2018
DOI
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Lizenz
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
Beschreibung
Unscheduled Vital Signs Conducted
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C3854240
Beschreibung
Measurement of Unscheduled Vital Signs
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0242485
- UMLS CUI [1,2]
- C0518766
- UMLS CUI [1,3]
- C3854240
Beschreibung
Staff initials
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2986440
- UMLS CUI [1,2]
- C1552089
Beschreibung
Unscheduled Vital Signs
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C3854240
Beschreibung
(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)
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0450973
- UMLS CUI [1,2]
- C1718255
Beschreibung
Reason for Assessment Specification
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0450973
- UMLS CUI [1,2]
- C1718255
- UMLS CUI [1,3]
- C2348235
Beschreibung
If assessment is a repeat of a scheduled time point please specify
Datentyp
text
Alias
- UMLS CUI [1]
- C1948053
Beschreibung
If assessment is a repeat of a scheduled time point please specify
Datentyp
text
Alias
- UMLS CUI [1]
- C2826182
Beschreibung
If assessment is a repeat of a scheduled time point please specify
Datentyp
text
Alias
- UMLS CUI [1]
- C2348792
Beschreibung
Date of Assessment
Datentyp
date
Alias
- UMLS CUI [1]
- C2985720
Beschreibung
Actual Time
Datentyp
time
Alias
- UMLS CUI [1]
- C0040223
Beschreibung
Position of Measurement
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2963216
- UMLS CUI [1,2]
- C1262869
Beschreibung
Other Position of Measurement Specification
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2963216
- UMLS CUI [1,2]
- C1262869
- UMLS CUI [1,3]
- C2348235
Beschreibung
Pulse Rate
Datentyp
integer
Maßeinheiten
- bpm
Alias
- UMLS CUI [1]
- C0232117
Beschreibung
Systolic Blood Pressure
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschreibung
Diastolic Blood Pressure
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschreibung
Oral Body Temperature
Datentyp
float
Maßeinheiten
- °C
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C0442027
Beschreibung
Respiration Rate
Datentyp
integer
Maßeinheiten
- breaths/min
Alias
- UMLS CUI [1]
- C0231832
Beschreibung
Second Position
Alias
- UMLS CUI-1
- C0733755
- UMLS CUI-2
- C0205436
Beschreibung
Actual Time
Datentyp
time
Alias
- UMLS CUI [1]
- C0040223
Beschreibung
Position of Measurement
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2963216
- UMLS CUI [1,2]
- C1262869
Beschreibung
Pulse Rate
Datentyp
integer
Maßeinheiten
- bpm
Alias
- UMLS CUI [1]
- C0232117
Beschreibung
Systolic Blood Pressure
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschreibung
Diastolic Blood Pressure
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschreibung
Conclusion
Alias
- UMLS CUI-1
- C1707478
Ähnliche Modelle
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])