ID

36211

Descrição

Study ID: 101963 Clinical Study ID: SCA101963 Study Title: A randomised, blinded, parallel group study to investigate the potential pharmacokinetic interaction between lamotrigine and risperidone in healthy, non-smoking, male volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: lamotrigine Trade Name: Lamictal XR,Lamictal,LAMICTIN Study Indication: Schizophrenia

Palavras-chave

Versões (1)
  1. 22/04/2019 22/04/2019 -
Titular dos direitos

GlaxoSmithKline

Transferido a

22 de abril de 2019

DOI

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Licença

Creative Commons BY-NC 3.0
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Potential Pharmacokinetic Interaction between Lamotrigine and Risperidone; 101963

Inglês

Non-Serious Adverse Events (NSAE)

1 Formulários  
Administrative Data
Descrição

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Descrição

Clinical Trial Subject Unique Identifier

Tipo de dados

integer

Alias
UMLS CUI [1]
C2348585
Non-Serious Adverse Events
Descrição

Non-Serious Adverse Events

Alias
UMLS CUI-1
C1518404
Did the subject experience any non-serious adverse events during the study?
Descrição

Non-serious Adverse Event

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1518404
Event
Descrição

Non-serious Adverse Event

Tipo de dados

text

Alias
UMLS CUI [1]
C1518404
Start Date
Descrição

Non-serious Adverse Event, Start Date

Tipo de dados

date

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

Non-serious Adverse Event, Start time

Tipo de dados

time

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

Non-serious Adverse Event, Adverse Event Outcome

Tipo de dados

text

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

Non-serious Adverse Event, End Date

Tipo de dados

date

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

Non-serious Adverse Event, End Time

Tipo de dados

time

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

Non-serious Adverse Event, Frequencies

Tipo de dados

text

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

Non-serious Adverse Event, Severity of Adverse Event

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1710066
Action Taken with lnvestigational Producl(s) as a ResuIt of the Non-Serious AE
Descrição

Non-serious Adverse Event, Action Taken with Study Treatment

Tipo de dados

text

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

Non-serious Adverse Event, Withdraw

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C2349954
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Descrição

Non-serious Adverse Event, Relationship, Experimental drug

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0304229
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Similar models

Non-Serious Adverse Events (NSAE)

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
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 non-serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1])
Non-serious Adverse Event
Item
Event
text
C1518404 (UMLS CUI [1])
Non-serious Adverse Event, Start Date
Item
Start Date
date
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Non-serious Adverse Event, Start time
Item
Start Time
time
C1518404 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Item
Outcome
text
C1518404 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Non-serious Adverse Event, Adverse Event Outcome
Code List
Outcome
CL Item
Recovered/ Resolved  (1)
CL Item
Recovering/ Resolving (2)
CL Item
Not recovered/ Not resolved (3)
CL Item
Recovered/ Resolved with sequelae (4)
Non-serious Adverse Event, End Date
Item
End Date
date
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Non-serious Adverse Event, End Time
Item
End Time
time
C1518404 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
Frequency
text
C1518404 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Non-serious Adverse Event, Frequencies
Code List
Frequency
CL Item
Single episode  (1)
CL Item
Intermittent (2)
Item
Maximum Intensity
text
C1518404 (UMLS CUI [1,1])
C1710066 (UMLS CUI [1,2])
Non-serious Adverse Event, Frequencies
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 lnvestigational Producl(s) as a ResuIt of the Non-Serious AE
text
C1518404 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])
Non-serious Adverse Event, Frequencies
Code List
Action Taken with lnvestigational Producl(s) as a ResuIt of the Non-Serious AE
CL Item
lnvestigational product(s) 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)
Non-serious Adverse Event, Withdraw
Item
Did the subject withdraw from study as a result of this AE?
boolean
C1518404 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
Non-serious Adverse Event, Relationship, Experimental drug
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C1518404 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
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