ID
36228
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)
- 4/23/19 4/23/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
April 23, 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
Pregnancy Notification Form (Subject's Partner)
- StudyEvent: ODM
Description
Mother's Relevant Medical/Family History
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C0026591
- UMLS CUI-3
- C0262926
Description
Pregnancy, Mother, Date of birth
Data type
date
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C0026591
- UMLS CUI [1,3]
- C0421451
Description
Pregnancy, Mother, Date of last menstrual period
Data type
date
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C0026591
- UMLS CUI [1,3]
- C0425932
Description
Pregnancy, Mother, Estimated date of delivery
Data type
date
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C0026591
- UMLS CUI [1,3]
- C1287845
Description
Pregnancy, Mother, Contraceptive method
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C0026591
- UMLS CUI [1,3]
- C0700589
Description
Pregnancy, Mother, Contraceptive method
Data type
text
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C0026591
- UMLS CUI [1,3]
- C0700589
Description
Pregnancy, Mother, Conception method
Data type
text
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C0026591
- UMLS CUI [1,3]
- C2598844
Description
Pregnancy, Mother, Laboratory Procedures, Medical Procedures
Data type
text
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C0026591
- UMLS CUI [1,3]
- C0022885
- UMLS CUI [1,4]
- C0199171
Description
Pregnancy, Mother, Number of Previous Pregnancies
Data type
text
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C0026591
- UMLS CUI [1,3]
- C0422807
Description
Pregnancy, Mother, Congenital Abnormality, number of children
Data type
text
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C0026591
- UMLS CUI [1,3]
- C0000768
- UMLS CUI [1,4]
- C2229974
Description
Pregnancy, Mother, Risk factors, Pregnancy Outcome
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C0026591
- UMLS CUI [1,3]
- C0035648
- UMLS CUI [1,4]
- C0032972
Description
Pregnancy, Mother, Risk factors, Pregnancy Outcome
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C0026591
- UMLS CUI [1,3]
- C0035648
- UMLS CUI [1,4]
- C0032972
Description
Father's Relevant Medical/Family History
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C0015671
- UMLS CUI-3
- C0262926
Description
Pregnancy, Father, Medical History
Data type
text
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C0015671
- UMLS CUI [1,3]
- C0262926
Description
Drug Exposures
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C0743284
Description
Drug exposure during pregnancy, Medication name
Data type
text
Alias
- UMLS CUI [1,1]
- C0877161
- UMLS CUI [1,2]
- C2360065
Description
Drug exposure during pregnancy, Drug Administration Routes
Data type
text
Alias
- UMLS CUI [1,1]
- C0877161
- UMLS CUI [1,2]
- C0013153
Description
Drug exposure during pregnancy, Daily Dose, Total
Data type
text
Alias
- UMLS CUI [1,1]
- C0877161
- UMLS CUI [1,2]
- C2348070
- UMLS CUI [1,3]
- C0439810
Description
Drug exposure during pregnancy, Unit of Measure
Data type
text
Alias
- UMLS CUI [1,1]
- C0877161
- UMLS CUI [1,2]
- C1519795
Description
Drug exposure during pregnancy, Start Date, Before, Clinical Trial Period
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0877161
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [1,3]
- C0332152
- UMLS CUI [1,4]
- C2347804
Description
Drug exposure during pregnancy, Start Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0877161
- UMLS CUI [1,2]
- C0808070
Description
Drug exposure during pregnancy, End Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0877161
- UMLS CUI [1,2]
- C0806020
Description
Drug exposure during pregnancy, Continuous
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0877161
- UMLS CUI [1,2]
- C0549178
Description
Drug exposure during pregnancy, Indication
Data type
text
Alias
- UMLS CUI [1,1]
- C0877161
- UMLS CUI [1,2]
- C3146298
Description
Pregnancy, Withdraw
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C2349954
Description
Reporting Investigator Information
Alias
- UMLS CUI-1
- C0008961
- UMLS CUI-2
- C1533716
Description
Investigator Name
Data type
text
Alias
- UMLS CUI [1]
- C2826892
Description
Clinical Investigators, Title
Data type
text
Alias
- UMLS CUI [1,1]
- C0008961
- UMLS CUI [1,2]
- C3888414
Description
Clinical Investigators, Medical Specialities
Data type
text
Alias
- UMLS CUI [1,1]
- C0008961
- UMLS CUI [1,2]
- C0037778
Description
Clinical Investigators, Address
Data type
text
Alias
- UMLS CUI [1,1]
- C0008961
- UMLS CUI [1,2]
- C1442065
Description
Clinical Investigators, Cities, State/Province
Data type
text
Alias
- UMLS CUI [1,1]
- C0008961
- UMLS CUI [1,2]
- C0008848
- UMLS CUI [1,3]
- C1547742
Description
Clinical Investigators, Country
Data type
text
Alias
- UMLS CUI [1,1]
- C0008961
- UMLS CUI [1,2]
- C0454664
Description
Clinical Investigators, Postal Code
Data type
text
Alias
- UMLS CUI [1,1]
- C0008961
- UMLS CUI [1,2]
- C1514254
Description
Clinical Investigators, Telephone Number
Data type
integer
Alias
- UMLS CUI [1,1]
- C0008961
- UMLS CUI [1,2]
- C1515258
Description
Clinical Investigators, Fax Number
Data type
integer
Alias
- UMLS CUI [1,1]
- C0008961
- UMLS CUI [1,2]
- C1549619
Description
Investigator Signature
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
Investigator Signature, Date in time
Data type
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Description
nvestigator Name
Data type
text
Alias
- UMLS CUI [1]
- C2826892
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Pregnancy Notification Form (Subject's Partner)
- StudyEvent: ODM
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C0034656 (UMLS CUI [1,2])
C0026591 (UMLS CUI-2)
C0262926 (UMLS CUI-3)
C0026591 (UMLS CUI [1,2])
C0421451 (UMLS CUI [1,3])
C0026591 (UMLS CUI [1,2])
C0425932 (UMLS CUI [1,3])
C0026591 (UMLS CUI [1,2])
C1287845 (UMLS CUI [1,3])
C0026591 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
C0026591 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
C0026591 (UMLS CUI [1,2])
C2598844 (UMLS CUI [1,3])
C0026591 (UMLS CUI [1,2])
C0022885 (UMLS CUI [1,3])
C0199171 (UMLS CUI [1,4])
C0026591 (UMLS CUI [1,2])
C0422807 (UMLS CUI [1,3])
C0026591 (UMLS CUI [1,2])
C0000768 (UMLS CUI [1,3])
C2229974 (UMLS CUI [1,4])
C0026591 (UMLS CUI [1,2])
C0035648 (UMLS CUI [1,3])
C0032972 (UMLS CUI [1,4])
C0026591 (UMLS CUI [1,2])
C0035648 (UMLS CUI [1,3])
C0032972 (UMLS CUI [1,4])
C0015671 (UMLS CUI-2)
C0262926 (UMLS CUI-3)
C0015671 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
C2360065 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,2])
C2348070 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
C1519795 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C2347804 (UMLS CUI [1,4])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,2])
C1533716 (UMLS CUI-2)
C3888414 (UMLS CUI [1,2])
C0037778 (UMLS CUI [1,2])
C1442065 (UMLS CUI [1,2])
C0008848 (UMLS CUI [1,2])
C1547742 (UMLS CUI [1,3])
C0454664 (UMLS CUI [1,2])
C1514254 (UMLS CUI [1,2])
C1515258 (UMLS CUI [1,2])
C1549619 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])