ID

33524

Beschrijving

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 information about the subjects 12-lead electrocardiogram. All ECGs will be recorder after 10 minutes rest in the semi-supine position. It should be filled out at screening visit. Unscheduled ECGs should be recorded whenever they have been performed 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

Trefwoorden

  1. 11-12-18 11-12-18 -
  2. 11-12-18 11-12-18 -
  3. 08-01-19 08-01-19 -
  4. 23-01-19 23-01-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

11 december 2018

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0

Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Effect of Lamictal on Resting Motor Threshold Study-ID 107434

  1. StudyEvent: ODM
    1. ECG
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Screening number
Beschrijving

Subject Screening No.

Datatype

integer

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

Subject Number

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Date Information Collected
Beschrijving

Date Information Collected

Datatype

date

Alias
UMLS CUI [1,1]
C3244127
UMLS CUI [1,2]
C0011008
12- Lead Electrocardiogram
Beschrijving

12- Lead Electrocardiogram

Alias
UMLS CUI-1
C0430456
Please record RR value
Beschrijving

Blood pressure

Datatype

integer

Alias
UMLS CUI [1]
C0005823
Result of ECG one
Beschrijving

If ECG abnormal and clinically significant, exclude

Datatype

integer

Alias
UMLS CUI [1]
C0438154
ECG comment
Beschrijving

ECG comment

Datatype

text

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0947611
Unscheduled 12-Lead Electrocardiogram
Beschrijving

Unscheduled 12-Lead Electrocardiogram

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C3854240
Actual Time
Beschrijving

Actual Time

Datatype

time

Alias
UMLS CUI [1]
C0040223
Please Record RR Value
Beschrijving

RR Value

Datatype

integer

Maateenheden
  • ms
Alias
UMLS CUI [1]
C0489636
ms
ECG Result
Beschrijving

Tick only one

Datatype

integer

Alias
UMLS CUI [1]
C0438154
Comment
Beschrijving

Please enter reason for repeat of ECG.

Datatype

text

Alias
UMLS CUI [1]
C0947611
Conclusion
Beschrijving

Conclusion

Alias
UMLS CUI-1
C1707478
Staff initials
Beschrijving

Staff initials

Datatype

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C1552089

Similar models

  1. StudyEvent: ODM
    1. ECG
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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
12- Lead Electrocardiogram
C0430456 (UMLS CUI-1)
Blood pressure
Item
Please record RR value
integer
C0005823 (UMLS CUI [1])
Item
Result of ECG one
integer
C0438154 (UMLS CUI [1])
Code List
Result of ECG one
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - clinically significant (3)
CL Item
No result (Not available) (4)
ECG comment
Item
ECG comment
text
C1623258 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Unscheduled 12-Lead Electrocardiogram
C0430456 (UMLS CUI-1)
C3854240 (UMLS CUI-2)
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
RR Value
Item
Please Record RR Value
integer
C0489636 (UMLS CUI [1])
Item
ECG Result
integer
C0438154 (UMLS CUI [1])
Code List
ECG Result
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically Significant (If Yes, Exclude (3)
CL Item
No result (not available) (4)
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
Conclusion
C1707478 (UMLS CUI-1)
Staff initials
Item
Staff initials
text
C2986440 (UMLS CUI [1,1])
C1552089 (UMLS CUI [1,2])

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial