ID

34032

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 is for documentation of the measurement of vital signs in the semi-supine position. It should be filled out at each treatment period visit. 3 measurements will be taken predose on Day 1, the baseline will be considered the mean of the 3 measurements 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

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  4. 11.01.19 11.01.19 - Sarah Riepenhausen
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

11. Januar 2019

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

Englisch

Semi-Supine Vital Signs (Treatment Period)

1 Formulare  
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Screening number
Beschreibung

Subject Screening No.

Datentyp

integer

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

Subject Number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Treatment Period
Beschreibung

Treatment Period

Datentyp

text

Alias
UMLS CUI [1]
C2347804
Semi-supine Vital Signs
Beschreibung

Semi-supine Vital Signs

Alias
UMLS CUI-1
C0522019
UMLS CUI-2
C0518766
Study Day
Beschreibung

Study Day

Datentyp

integer

Alias
UMLS CUI [1]
C2826182
Protocol Time
Beschreibung

3 measurements will be taken predose on Day 1, the baseline will be considered the mean of the 3 measurements (see Baseline Vital Signs Itemgroup)

Datentyp

text

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C2348563
Date
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Actual Time
Beschreibung

Actual Time

Datentyp

time

Alias
UMLS CUI [1]
C0040223
Pulse
Beschreibung

To be measured after 10 minutes in semi-supine position.

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1]
C0232117
bpm
Systolic Blood Pressure
Beschreibung

To be measured after 10 minutes in semi-supine position.

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Beschreibung

To be measured after 10 minutes in semi-supine position.

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Comments
Beschreibung

Comments

Datentyp

text

Alias
UMLS CUI [1]
C0947611
Where the vital signs out of range?
Beschreibung

Vital Abnormal

Datentyp

boolean

Alias
UMLS CUI [1]
C0277804
If out of range, have these been repeated?
Beschreibung

No = Asymptomatic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0205341
UMLS CUI [1,3]
C0242485
Clinical Staff Initials
Beschreibung

Clinical Staff Initials

Datentyp

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C1552089
Baseline Vital Signs
Beschreibung

Baseline Vital Signs

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C1442488
Pulse Baseline
Beschreibung

Baseline = Mean measurement of triplicate Pre dose vital signs

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1,1]
C0232117
UMLS CUI [1,2]
C1442488
bpm
Blood Pressure Systolic Baseline
Beschreibung

Blood Pressure Systolic Baseline

Datentyp

integer

Alias
UMLS CUI [1]
C0871470
Blood Pressure Diastolic Baseline
Beschreibung

Blood Pressure Diastolic Baseline

Datentyp

integer

Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C1442488
Physician's initials
Beschreibung

Mean calculated by

Datentyp

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C0031831
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Ähnliche Modelle

Semi-Supine Vital Signs (Treatment Period)

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
Item
Treatment Period
text
C2347804 (UMLS CUI [1])
Treatment Period
Code List
Treatment Period
CL Item
Treatment Period 1 (Treatment Period 1)
CL Item
Treatment Period 2 (Treatment Period 2)
CL Item
Treatment Period 3 (Treatment Period 3)
Item Group
Semi-supine Vital Signs
C0522019 (UMLS CUI-1)
C0518766 (UMLS CUI-2)
Item
Study Day
integer
C2826182 (UMLS CUI [1])
Study Day
Code List
Study Day
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Item
Protocol Time
text
C0040223 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Protocol Time
Code List
Protocol Time
CL Item
Pre-Dose (Pre-Dose)
CL Item
1h30 post-dose (1h30 post-dose)
CL Item
5h00 post-dose (5h00 post-dose)
CL Item
12h00 post-dose (12h00 post-dose)
CL Item
24h00 post-dose (24h00 post-dose)
CL Item
48h00 post-dose (48h00 post-dose)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Pulse
Item
Pulse
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])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Vital Abnormal
Item
Where the vital signs out of range?
boolean
C0277804 (UMLS CUI [1])
Vital Signs Repeated
Item
If out of range, have these been repeated?
boolean
C0518766 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
C0242485 (UMLS CUI [1,3])
Clinical Staff Initials
Item
Clinical Staff Initials
text
C2986440 (UMLS CUI [1,1])
C1552089 (UMLS CUI [1,2])
Item Group
Baseline Vital Signs
C0518766 (UMLS CUI-1)
C1442488 (UMLS CUI-2)
Pulse Baseline
Item
Pulse Baseline
integer
C0232117 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
Blood Pressure Systolic Baseline
Item
Blood Pressure Systolic Baseline
integer
C0871470 (UMLS CUI [1])
Blood Pressure Diastolic Baseline
Item
Blood Pressure Diastolic Baseline
integer
C0428883 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
Physician's initials
Item
Physician's initials
text
C2986440 (UMLS CUI [1,1])
C0031831 (UMLS CUI [1,2])
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