ID

36216

Description

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

Keywords

Versions (1)
  1. 4/22/19 4/22/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

April 22, 2019

DOI

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License

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

English

Pregnancy Information

1 forms  
  1. StudyEvent: ODM
    1. Pregnancy Information
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Clinical Trial Subject Unique Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Pregnancy Information
Description

Pregnancy Information

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Did the subject become pregnant during the study?
Description

Pregnant During the Study

Data type

text

Alias
UMLS CUI [1]
C3828490
Did a female partner of the male subject become pregnant during the study?
Description

Pregnancy of partner, During, Clinical Research

Data type

text

Alias
UMLS CUI [1,1]
C0919624
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008972
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Similar models

Pregnancy Information

1 forms
  1. StudyEvent: ODM
    1. Pregnancy Information
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item Group
Pregnancy Information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Item
Did the subject become pregnant during the study?
text
C3828490 (UMLS CUI [1])
Pregnant During the Study
Code List
Did the subject become pregnant during the study?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Applicable (not of childbearing potential or male) (3)
Item
Did a female partner of the male subject become pregnant during the study?
text
C0919624 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008972 (UMLS CUI [1,3])
Pregnancy of partner, During, Clinical Research
Code List
Did a female partner of the male subject become pregnant during the study?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Applicable (subject is female, female partner not of childbearing potential or no female partner) (3)
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