ID
36218
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
Serious Adverse Event (SAE)
- StudyEvent: ODM
Description
Serious Adverse Events - Section 1
Alias
- UMLS CUI-1
- C1519255
Description
Serious Adverse Event
Data type
boolean
Alias
- UMLS CUI [1]
- C1519255
Description
Serious Adverse Event
Data type
text
Alias
- UMLS CUI [1]
- C1519255
Description
Serious Adverse Event, Start Date
Data type
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0808070
Description
Serious Adverse Event, Start time
Data type
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1301880
Description
Serious Adverse Event, Adverse Event Outcome
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1705586
Description
Serious Adverse Event, End Date
Data type
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0806020
Description
Serious Adverse Event, End Time
Data type
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1522314
Description
Serious Adverse Event, Severity of Adverse Event
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1710066
Description
Serious Adverse Event, Action Taken with Study Treatment
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1704758
Description
Serious Adverse Event, Withdraw
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2349954
Description
Serious Adverse Event, Relationship, Experimental drug
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0439849
- UMLS CUI [1,3]
- C0304229
Description
Serious Adverse Event, Fatal, Autopsy
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1302234
- UMLS CUI [1,3]
- C0004398
Description
Seriousness
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C1710066
Description
Demography Data
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0011298
Description
If lnvestigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further lnvestigational Product(s) were Administered?
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0439849
- UMLS CUI-3
- C0304229
Description
Possible Causes of SAE Other Than lnvestigational Product(s)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0085978
Description
Serious Adverse Event, Causations
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
Description
Relevant Medical Conditions
Alias
- UMLS CUI-1
- C0012634
Description
Medical History; Hypersensitivity; Operative Surgical Procedures
Data type
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0020517
- UMLS CUI [1,3]
- C0543467
Description
Disease, Date of Onset
Data type
date
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0574845
Description
Disease, During, Serious Adverse Event
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C1519255
Description
Disease, Occurrence, Date in time
Data type
date
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2745955
- UMLS CUI [1,3]
- C0011008
Description
Other Relevant Risk Factors
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0035648
Description
Relevant Concomitant Medications
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2347852
Description
Serious Adverse Event, Concomitant Agent, Medication name
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C2360065
Description
Serious Adverse Event, Concomitant Agent, Medication dose
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C3174092
Description
Serious Adverse Event, Concomitant Agent, Unit
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0439148
Description
Serious Adverse Event, Concomitant Agent, Frequencies
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0439603
Description
Serious Adverse Event, Concomitant Agent, Drug Administration Routes
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0013153
Description
Serious Adverse Event, Concomitant Medication Previous Occurence
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826667
Description
Serious Adverse Event, Concomitant Agent, Start Date
Data type
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0808070
Description
Serious Adverse Event, Concomitant Agent, End Date
Data type
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0806020
Description
Serious Adverse Event, Concomitant Medication Ongoing
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826666
Description
Serious Adverse Event, Concomitant Agent, Indication
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0392360
Description
Details of lnvestigational Product(s)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0304229
Description
Serious Adverse Event, Experimental drug, Dosage, Date in time
Data type
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C0178602
- UMLS CUI [1,4]
- C0011008
Description
Serious Adverse Event, Experimental drug, Dosage, Time
Data type
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C0178602
- UMLS CUI [1,4]
- C0040223
Description
Details of Relevant Assessments
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0220825
- UMLS CUI-3
- C1522508
Description
Serious Adverse Event, Evaluation, Details
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0220825
- UMLS CUI [1,3]
- C1522508
Description
Narrative Remarks
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0947611
Description
Investigator Signature
Alias
- UMLS CUI-1
- C2346576
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
Investigator Name
Data type
text
Alias
- UMLS CUI [1]
- C2826892
Similar models
Serious Adverse Event (SAE)
- StudyEvent: ODM
C1300638 (UMLS CUI [1,2])
C1300638 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
C1705586 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
C1710066 (UMLS CUI [1,2])
C1704758 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C1302234 (UMLS CUI [1,2])
C0004398 (UMLS CUI [1,3])
C1710066 (UMLS CUI-2)
C1710066 (UMLS CUI [1,2])
C0011298 (UMLS CUI-2)
C0439849 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0085978 (UMLS CUI-2)
C0085978 (UMLS CUI [1,2])
C0020517 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
C0574845 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C2745955 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0035648 (UMLS CUI-2)
C0035648 (UMLS CUI [1,2])
C2347852 (UMLS CUI-2)
C2347852 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C0439148 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C2826667 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
C2826666 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C0304229 (UMLS CUI-2)
C0304229 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0220825 (UMLS CUI-2)
C1522508 (UMLS CUI-3)
C0220825 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])
C0947611 (UMLS CUI-2)
C0947611 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])