ID

33759

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 information about any non-serious adverse events ocurring during the study. It should be filled out if any non-serious adverse events occurred. 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 (1)
  1. 24.12.18 24.12.18 -
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GlaxoSmithKline

Hochgeladen am

24. Dezember 2018

DOI

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Effect of Lamictal on Resting Motor Threshold Study-ID 107434

Englisch

Non-Serious Adverse Events Form

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
Non-serious Adverse Events
Beschreibung

Non-serious Adverse Events

Alias
UMLS CUI-1
C1518404
Did the subject experience any NSAE?
Beschreibung

Non Serious Adverse Event

Datentyp

boolean

Alias
UMLS CUI [1]
C1518404
Staff initials
Beschreibung

Staff initials

Datentyp

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C1552089
Non-serious Adverse Events Record
Beschreibung

Non-serious Adverse Events Record

Alias
UMLS CUI-1
C1518404
Non-serious Adverse Event
Beschreibung

Diagnosis only (if known) otherwise signs/symptoms

Datentyp

text

Alias
UMLS CUI [1]
C1518404
Start Date
Beschreibung

Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1518404
Start Time
Beschreibung

Start Time

Datentyp

time

Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C1518404
Outcome
Beschreibung

Outcome

Datentyp

text

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1518404
End Date
Beschreibung

End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1518404
End Time
Beschreibung

End Time

Datentyp

time

Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C1518404
Frequency
Beschreibung

Frequency

Datentyp

integer

Alias
UMLS CUI [1,1]
C0439603
UMLS CUI [1,2]
C1518404
Maximum Intensity
Beschreibung

Maximum Intensity

Datentyp

integer

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C1518404
Action Taken with Investigational Product
Beschreibung

Action Taken with Investigational Product

Datentyp

integer

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C1518404
Did the subject withdraw from the study as a result of this AE?
Beschreibung

Withdrawal

Datentyp

text

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C1518404
Is there a reasonable possibility that the AE may have been caused by the investigational product
Beschreibung

Relationship to Investigational Product

Datentyp

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1518404
Conclusion
Beschreibung

Conclusion

Alias
UMLS CUI-1
C1707478
Is this the last page of Non-serious Adverse Events?
Beschreibung

Last Page

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1704732
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C1518404
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Ähnliche Modelle

Non-Serious Adverse Events Form

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 Group
Non-serious Adverse Events
C1518404 (UMLS CUI-1)
Non Serious Adverse Event
Item
Did the subject experience any NSAE?
boolean
C1518404 (UMLS CUI [1])
Staff initials
Item
Staff initials
text
C2986440 (UMLS CUI [1,1])
C1552089 (UMLS CUI [1,2])
Item Group
Non-serious Adverse Events Record
C1518404 (UMLS CUI-1)
Non-serious Adverse Event
Item
Non-serious Adverse Event
text
C1518404 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Start Time
Item
Start Time
time
C1301880 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Outcome
text
C1705586 (UMLS CUI [1,1])
C1518404 (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])
C1518404 (UMLS CUI [1,2])
End Time
Item
End Time
time
C1522314 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Frequency
integer
C0439603 (UMLS CUI [1,1])
C1518404 (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])
C1518404 (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])
C1518404 (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])
C1518404 (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])
C1518404 (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)
Item Group
Conclusion
C1707478 (UMLS CUI-1)
Last Page
Item
Is this the last page of Non-serious Adverse Events?
boolean
C1704732 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
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