ID

36217

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

Study Conclusion

1 forms  
  1. StudyEvent: ODM
    1. Study Conclusion
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
Study Conclusion
Description

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Date of subject completion or withdrawal
Description

Report completion date; Patient withdrawn from trial, Date in time

Data type

date

Alias
UMLS CUI [1]
C1549507
UMLS CUI [2,1]
C0422727
UMLS CUI [2,2]
C0011008
Time of withdrawal
Description

Withdraw, Time

Data type

time

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0040223
Was the subject withdrawn from the study?
Description

Subject withdrawn from trial

Data type

boolean

Alias
UMLS CUI [1]
C0422727
If Yes, tick he primary reason for withdrawal:
Description

Subject withdrawn from trial, Indication

Data type

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C3146298
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Similar models

Study Conclusion

1 forms
  1. StudyEvent: ODM
    1. Study Conclusion
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
Study Conclusion
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Report completion date; Patient withdrawn from trial, Date in time
Item
Date of subject completion or withdrawal
date
C1549507 (UMLS CUI [1])
C0422727 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
Withdraw, Time
Item
Time of withdrawal
time
C2349954 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Subject withdrawn from trial
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Item
If Yes, tick he primary reason for withdrawal:
text
C0422727 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
Subject withdrawn from trial, Indication
Code List
If Yes, tick he primary reason for withdrawal:
CL Item
Adverse event  (1)
CL Item
Lost to follow-up (2)
CL Item
Protocol violation (3)
CL Item
Subject decided to withdraw from the study (4)
CL Item
Sponsor terminated study (5)
CL Item
Other (6)
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