ID

33761

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 any serious adverse events ocurring during the study. It should be filled out if any serious adverse events ocurred. 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

Versies (2)
  1. 25-12-18 25-12-18 -
  2. 25-12-18 25-12-18 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

25 december 2018

DOI

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Licentie

Creative Commons BY-NC 3.0
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Effect of Lamictal on Resting Motor Threshold Study-ID 107434

Engels

Serious Adverse Event Record Form

1 Formulieren  
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
Serious Adverse Events
Beschrijving

Serious Adverse Events

Alias
UMLS CUI-1
C1519255
Did the Subject experience any Serious adverse events?
Beschrijving

Serious Adverse Event

Datatype

boolean

Alias
UMLS CUI [1]
C1519255
Staff initials
Beschrijving

Staff initials

Datatype

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C1552089
Serious Adverse Event Record
Beschrijving

Serious Adverse Event Record

Alias
UMLS CUI-1
C0877248
Serious Adverse Event
Beschrijving

Diagnosis only (if known) otherwise signs/symptoms

Datatype

text

Alias
UMLS CUI [1]
C1519255
Start Date
Beschrijving

Start Date

Datatype

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1519255
Start Time
Beschrijving

Start Time

Datatype

time

Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C1519255
Outcome
Beschrijving

Outcome

Datatype

text

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1519255
End Date
Beschrijving

End Date

Datatype

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1519255
End Time
Beschrijving

End Time

Datatype

time

Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C1519255
Frequency
Beschrijving

Frequency

Datatype

integer

Alias
UMLS CUI [1,1]
C0439603
UMLS CUI [1,2]
C1519255
Maximum Intensity
Beschrijving

Maximum Intensity

Datatype

integer

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C1519255
Action Taken with Investigational Product
Beschrijving

Action Taken with Investigational Product

Datatype

integer

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C1519255
Did the subject withdraw from the study as a result of this AE?
Beschrijving

Withdrawal

Datatype

text

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C1519255
Is there a reasonable possibility that the AE may have been caused by the investigational product
Beschrijving

Relationship to Investigational Product

Datatype

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1519255
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Similar models

Serious Adverse Event Record Form

1 Formulieren
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])
Item Group
Serious Adverse Events
C1519255 (UMLS CUI-1)
Serious Adverse Event
Item
Did the Subject experience any Serious adverse events?
boolean
C1519255 (UMLS CUI [1])
Staff initials
Item
Staff initials
text
C2986440 (UMLS CUI [1,1])
C1552089 (UMLS CUI [1,2])
Item Group
Serious Adverse Event Record
C0877248 (UMLS CUI-1)
Serious Adverse Event
Item
Serious Adverse Event
text
C1519255 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Start Time
Item
Start Time
time
C1301880 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Outcome
text
C1705586 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Outcome
Code List
Outcome
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/ Not resolving (3)
CL Item
Recovered/Resolved with sequelae (4)
End Date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
End Time
Item
End Time
time
C1522314 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Frequency
integer
C0439603 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Frequency
Code List
Frequency
CL Item
Single episode (1)
CL Item
Intermittent (2)
Item
Maximum Intensity
integer
C1710056 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Maximum Intensity
Code List
Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (4)
Item
Action Taken with Investigational Product
integer
C1704758 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Action Taken with Investigational Product
Code List
Action Taken with Investigational Product
CL Item
Withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not Applicable (6)
Item
Did the subject withdraw from the study as a result of this AE?
text
C1710677 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Withdrawal
Code List
Did the subject withdraw from the study as a result of this AE?
CL Item
Yes (Y)
CL Item
No (N)
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product
text
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Relationship to Investigational Product
Code List
Is there a reasonable possibility that the AE may have been caused by the investigational product
CL Item
Yes (Y)
CL Item
No (N)
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