ID

33590

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 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

Nyckelord

Versioner (3)
  1. 2018-12-03 2018-12-03 -
  2. 2018-12-14 2018-12-14 -
  3. 2019-01-09 2019-01-09 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

14 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

Unscheduled Vital Signs

1 Formulär  
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
Unscheduled Vital Signs Conducted
Beskrivning

Unscheduled Vital Signs Conducted

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C3854240
Were any additional/repeat vital signs measurements conducted?
Beskrivning

Measurement of Unscheduled Vital Signs

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0242485
UMLS CUI [1,2]
C0518766
UMLS CUI [1,3]
C3854240
Staff initials
Beskrivning

Staff initials

Datatyp

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C1552089
Unscheduled Vital Signs
Beskrivning

Unscheduled Vital Signs

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C3854240
Reason for Assessment
Beskrivning

(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)

Datatyp

integer

Alias
UMLS CUI [1,1]
C0450973
UMLS CUI [1,2]
C1718255
Reason for Assessment Specification
Beskrivning

Reason for Assessment Specification

Datatyp

integer

Alias
UMLS CUI [1,1]
C0450973
UMLS CUI [1,2]
C1718255
UMLS CUI [1,3]
C2348235
Period
Beskrivning

If assessment is a repeat of a scheduled time point please specify

Datatyp

text

Alias
UMLS CUI [1]
C1948053
Protocol Day
Beskrivning

If assessment is a repeat of a scheduled time point please specify

Datatyp

text

Alias
UMLS CUI [1]
C2826182
Protocol Time Point
Beskrivning

If assessment is a repeat of a scheduled time point please specify

Datatyp

text

Alias
UMLS CUI [1]
C2348792
Date of Assessment
Beskrivning

Date of Assessment

Datatyp

date

Alias
UMLS CUI [1]
C2985720
Actual Time
Beskrivning

Actual Time

Datatyp

time

Alias
UMLS CUI [1]
C0040223
Position
Beskrivning

Position of Measurement

Datatyp

text

Alias
UMLS CUI [1,1]
C2963216
UMLS CUI [1,2]
C1262869
Other Position of Measurement Specification
Beskrivning

Other Position of Measurement Specification

Datatyp

text

Alias
UMLS CUI [1,1]
C2963216
UMLS CUI [1,2]
C1262869
UMLS CUI [1,3]
C2348235
Pulse Rate
Beskrivning

Pulse Rate

Datatyp

integer

Måttenheter
  • bpm
Alias
UMLS CUI [1]
C0232117
bpm
Systolic Blood Pressure
Beskrivning

Systolic Blood Pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Beskrivning

Diastolic Blood Pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Oral Body Temperature
Beskrivning

Oral Body Temperature

Datatyp

float

Måttenheter
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0442027
°C
Respiration Rate
Beskrivning

Respiration Rate

Datatyp

integer

Måttenheter
  • breaths/min
Alias
UMLS CUI [1]
C0231832
breaths/min
Second Position
Beskrivning

Second Position

Alias
UMLS CUI-1
C0733755
UMLS CUI-2
C0205436
Actual Time
Beskrivning

Actual Time

Datatyp

time

Alias
UMLS CUI [1]
C0040223
Position
Beskrivning

Position of Measurement

Datatyp

text

Alias
UMLS CUI [1,1]
C2963216
UMLS CUI [1,2]
C1262869
Pulse Rate
Beskrivning

Pulse Rate

Datatyp

integer

Måttenheter
  • bpm
Alias
UMLS CUI [1]
C0232117
bpm
Systolic Blood Pressure
Beskrivning

Systolic Blood Pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Beskrivning

Diastolic Blood Pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Conclusion
Beskrivning

Conclusion

Alias
UMLS CUI-1
C1707478
Clinical Staff initials
Beskrivning

Clinical Staff initials

Datatyp

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C0871685
Physician Comment
Beskrivning

If required

Datatyp

text

Alias
UMLS CUI [1,1]
C0031831
UMLS CUI [1,2]
C0947611
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Similar models

Unscheduled Vital Signs

1 Formulär
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
Unscheduled Vital Signs Conducted
C0518766 (UMLS CUI-1)
C3854240 (UMLS CUI-2)
Measurement of Unscheduled Vital Signs
Item
Were any additional/repeat vital signs measurements conducted?
boolean
C0242485 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
C3854240 (UMLS CUI [1,3])
Staff initials
Item
Staff initials
text
C2986440 (UMLS CUI [1,1])
C1552089 (UMLS CUI [1,2])
Item Group
Unscheduled Vital Signs
C0518766 (UMLS CUI-1)
C3854240 (UMLS CUI-2)
Item
Reason for Assessment
integer
C0450973 (UMLS CUI [1,1])
C1718255 (UMLS CUI [1,2])
Reason for Assessment
Code List
Reason for Assessment
CL Item
Outside of reference range (1)
CL Item
Protocol requirement (2)
CL Item
Physician request (Specify) (3)
CL Item
Adverse event (Specify) (4)
CL Item
Other (Specify) (5)
Item
Reason for Assessment Specification
integer
C0450973 (UMLS CUI [1,1])
C1718255 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Reason for Assessment Specification
Code List
Reason for Assessment Specification
CL Item
Outside of reference range (1)
CL Item
Protocol requirement (2)
CL Item
Physician request (Specify) (3)
CL Item
Adverse event (Specify) (4)
CL Item
Other (Specify) (5)
Period
Item
Period
text
C1948053 (UMLS CUI [1])
Protocol Day
Item
Protocol Day
text
C2826182 (UMLS CUI [1])
Protocol Time Point
Item
Protocol Time Point
text
C2348792 (UMLS CUI [1])
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Item
Position
text
C2963216 (UMLS CUI [1,1])
C1262869 (UMLS CUI [1,2])
Position of Measurement
Code List
Position
CL Item
Supine (Supine)
CL Item
Standing (Standing)
CL Item
Sitting (Sitting)
CL Item
Other (Other)
Item
Other Position of Measurement Specification
text
C2963216 (UMLS CUI [1,1])
C1262869 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Position of Measurement
Code List
Other Position of Measurement Specification
Pulse Rate
Item
Pulse Rate
integer
C0232117 (UMLS CUI [1])
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1])
Oral Body Temperature
Item
Oral Body Temperature
float
C0005903 (UMLS CUI [1,1])
C0442027 (UMLS CUI [1,2])
Respiration Rate
Item
Respiration Rate
integer
C0231832 (UMLS CUI [1])
Item Group
Second Position
C0733755 (UMLS CUI-1)
C0205436 (UMLS CUI-2)
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Item
Position
text
C2963216 (UMLS CUI [1,1])
C1262869 (UMLS CUI [1,2])
Position of Measurement
Code List
Position
CL Item
Supine (Supine)
CL Item
Standing (Standing)
CL Item
Sitting (Sitting)
CL Item
Other (Other)
Pulse Rate
Item
Pulse Rate
integer
C0232117 (UMLS CUI [1])
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1])
Item Group
Conclusion
C1707478 (UMLS CUI-1)
Clinical Staff initials
Item
Clinical Staff initials
text
C2986440 (UMLS CUI [1,1])
C0871685 (UMLS CUI [1,2])
Physician Comment
Item
Physician Comment
text
C0031831 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
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