ID
39305
Description
Study ID: 110771 Clinical Study ID: 110771 Study Title: An open label positron emission tomography (PET) study to investigate brain penetration by [carbonyl-11C] GSK1034702 in healthy subjects 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: Positron Emission Tomography Trade Name: Carbonyl-11C Study Indication: Cognitive Disorders, Alzheimer's disease, schizophrenia.
Keywords
Versions (1)
- 12/18/19 12/18/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
December 18, 2019
DOI
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License
Creative Commons BY-NC 3.0
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Brain Penetration by [Carbonyl-11C] GSK1034702; 110771
Serious Adverse Event (SAE)
- StudyEvent: ODM
Description
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, Grade, Maximum; Serious Adverse Event, Symptom Intensity, Maximum
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0806909
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C0518690
- UMLS CUI [2,3]
- C0806909
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, Relationships, 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
Section 2: Seriousness
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C1710056
Description
Serious Adverse Event, Seriousness of Adverse Event
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1710056
Description
Serious Adverse Event, Seriousness of Adverse Event
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1710056
Description
Serious 3: Demography Data
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0011298
Description
Serious Adverse Event, Patient date of birth
Data type
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0421451
Description
Serious Adverse Event, Gender
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0079399
Description
Serious Adverse Event, Body Weight
Data type
float
Measurement units
- kg
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0005910
Description
Section 4: If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0439849
- UMLS CUI-3
- C0304229
Description
Section 5: Possible Causes of SAE Other Than Investigational Product(s)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0015127
Description
Serious Adverse Event, Etiology aspects
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0015127
Description
Serious Adverse Event, Etiology aspects
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0015127
Description
Section 6: Relevant Medical Conditions
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0012634
Description
Serious Adverse Event, Disease; Serious Adverse Event, Hypersensitivity; Serious Adverse Event, Operative Surgical Procedures
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C0020517
- UMLS CUI [3,1]
- C1519255
- UMLS CUI [3,2]
- C0543467
Description
Serious Adverse Event, Disease, Start Date; Serious Adverse Event, Hypersensitivity, Start Date; Serious Adverse Event, Operative Surgical Procedures, Start Date
Data type
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C0808070
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C0020517
- UMLS CUI [2,3]
- C0808070
- UMLS CUI [3,1]
- C1519255
- UMLS CUI [3,2]
- C0543467
- UMLS CUI [3,3]
- C0808070
Description
Serious Adverse Event, Disease, Present; Serious Adverse Event, Hypersensitivity, Present; Serious Adverse Event, Operative Surgical Procedures, Present
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C0150312
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C0020517
- UMLS CUI [2,3]
- C0150312
- UMLS CUI [3,1]
- C1519255
- UMLS CUI [3,2]
- C0543467
- UMLS CUI [3,3]
- C0150312
Description
Serious Adverse Event, Disease, End Date; Serious Adverse Event, Hypersensitivity, End Date; Serious Adverse Event, Operative Surgical Procedures, End Date
Data type
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C0806020
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C0020517
- UMLS CUI [2,3]
- C0806020
- UMLS CUI [3,1]
- C1519255
- UMLS CUI [3,2]
- C0543467
- UMLS CUI [3,3]
- C0806020
Description
Section 7: Other Relevant Risk Factors
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0035648
Description
Section 8: 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, Dosage
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0178602
Description
Serious Adverse Event, Concomitant Agent, Unit of Measure
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C1519795
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 Occurrence
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826667
Description
Serious Adverse Event, Concomitant Medication Start Date
Data type
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826734
Description
Serious Adverse Event, Concomitant Medication End Date
Data type
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826744
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, Reason and justification
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0566251
Description
Section 9: Details of Investigational Product(s)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0304229
- UMLS CUI-3
- C1522508
Description
Section 10: Details of Relevant Assessments
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0430022
Description
Section 11: Narrative Remarks
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0947611
Description
Investigator's Signature
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2346576
Description
Serious Adverse Event, Investigator Signature
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2346576
Description
Serious Adverse Event, Investigator Signature, Date in time
Data type
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2346576
- UMLS CUI [1,3]
- C0011008
Description
Serious Adverse Event, Investigator Name
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826892
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Serious Adverse Event (SAE)
- StudyEvent: ODM
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C0543467 (UMLS CUI [3,2])
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C2826734 (UMLS CUI [1,2])
C2826744 (UMLS CUI [1,2])
C2826666 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C0304229 (UMLS CUI-2)
C1522508 (UMLS CUI-3)
C0304229 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])
C0430022 (UMLS CUI-2)
C0430022 (UMLS CUI [1,2])
C0947611 (UMLS CUI-2)
C0947611 (UMLS CUI [1,2])
C2346576 (UMLS CUI-2)
C2346576 (UMLS CUI [1,2])
C2346576 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C2826892 (UMLS CUI [1,2])