ID
36905
Beschrijving
Study ID: 109731 Clinical Study ID: 109731 Study Title: An adaptive PET study in healthy volunteers using 11C GSK931145 to establish the relationship of Glycine Transporter1 occupancy by GSK1018921 to plasma concentrations over time Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00945503 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK1018921 Study Indication: Schizophrenia
Trefwoorden
Versies (1)
- 20-06-19 20-06-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
20 juni 2019
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
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The relationship of Glycine Transporter1 occupancy by GSK1018921 to plasma concentrations over time NCT00945503
Concomitant Medications; Non-Serious Adverse Events; Serious Adverse Events
Beschrijving
Concomitant Medications
Alias
- UMLS CUI-1
- C2347852
Beschrijving
Concomitant Medications
Alias
- UMLS CUI-1
- C2347852
Beschrijving
Trade Name preferred
Datatype
text
Alias
- UMLS CUI [1]
- C0013227
Beschrijving
Concomitant Medication Unit Dose
Datatype
float
Alias
- UMLS CUI [1,1]
- C0869039
- UMLS CUI [1,2]
- C2347852
Beschrijving
Concomitant Medication Units
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C2347852
Beschrijving
Concomitant Medications Frequency
Datatype
text
Alias
- UMLS CUI [1,1]
- C3476109
- UMLS CUI [1,2]
- C2347852
Beschrijving
Concomitant Medication Route
Datatype
text
Alias
- UMLS CUI [1]
- C2826730
Beschrijving
Reason for Medication
Datatype
text
Alias
- UMLS CUI [1]
- C2826696
Beschrijving
Concomitant Medication Start Date
Datatype
date
Alias
- UMLS CUI [1]
- C2826734
Beschrijving
Concomitant Medication Start Time
Datatype
time
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C2347852
Beschrijving
Concomitant Medication taken prior to study?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2603343
- UMLS CUI [1,3]
- C1883727
- UMLS CUI [1,4]
- C0332152
Beschrijving
Concomitant Medication Stop Date
Datatype
date
Alias
- UMLS CUI [1]
- C2826744
Beschrijving
Concomitant Medication Stop Time
Datatype
time
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1522314
Beschrijving
Ongoing Medication?
Datatype
boolean
Alias
- UMLS CUI [1]
- C2826666
Beschrijving
Non-Serious Adverse Events
Alias
- UMLS CUI-1
- C1518404
Beschrijving
Non-Serious Adverse Events
Alias
- UMLS CUI-1
- C1518404
Beschrijving
Diagnosis Only (if known) Otherwise Sign/Symptom
Datatype
text
Alias
- UMLS CUI [1]
- C1518404
Beschrijving
Non-Serious Adverse Event Start Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0808070
Beschrijving
Non-Serious Adverse Event Start Time
Datatype
time
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1301880
Beschrijving
Non-Serious Adverse Event Outcome
Datatype
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1705586
Beschrijving
Non-Serious Adverse Event End Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0806020
Beschrijving
Non-Serious Adverse Event End Time
Datatype
time
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1522314
Beschrijving
Non-Serious Adverse Event Frequency
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0439603
Beschrijving
Non-Serious Adverse Event Maximum Intensity
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0806909
Beschrijving
Action Taken with investigational Product(s) as a Result of the Non-Serious AE
Datatype
text
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1518404
Beschrijving
Did the subject withdraw from study as a result of this AE?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1710677
- UMLS CUI [1,2]
- C1518404
Beschrijving
ls there a reasonable possibility that the AE may have been caused by the investigational product?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Beschrijving
Serious Adverse Event
Alias
- UMLS CUI-1
- C1519255
Beschrijving
Serious Adverse Event - Section 1
Alias
- UMLS CUI-1
- C1519255
Beschrijving
Diagnosis Only (if known) Otherwise Sign/Symptom
Datatype
text
Alias
- UMLS CUI [1]
- C1519255
Beschrijving
Serious Adverse Event Start Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0808070
Beschrijving
Serious Adverse Event Start Time
Datatype
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1301880
Beschrijving
Serious Adverse Event Outcome
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1705586
- UMLS CUI [1,2]
- C1519255
Beschrijving
If fatal, record date of death.
Datatype
date
Alias
- UMLS CUI [1]
- C1519255
Beschrijving
Serious Adverse Event Maximum Intensity
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0806909
Beschrijving
Action Taken with lnvestigational Product(s) as a Result of the SAE
Datatype
text
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1519255
Beschrijving
Did the subject withdraw from study as a result of this SAE?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C1519255
Beschrijving
ls there a reasonable possibility the SAE may have been caused by the investigational product?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Beschrijving
Serious Adverse Event - Section 2 Seriousness
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C1710056
Beschrijving
Serious Adverse Event Seriousness
Datatype
text
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C1519255
Beschrijving
If other Sersiousness of SAE, specify.
Datatype
text
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Beschrijving
Serious Adverse Event - Section 3 Demography Data
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0011298
Beschrijving
Serious Adverse Event - Section 4
Alias
- UMLS CUI-1
- C1519255
Beschrijving
If investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further lnvestigational Product(s) were Administered?
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0034897
Beschrijving
Serious Adverse Event - Section 5
Alias
- UMLS CUI-1
- C1519255
Beschrijving
Check all that apply:
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [2,1]
- C0304229
- UMLS CUI [2,2]
- C0205394
Beschrijving
Medical conditions(s) specification
Datatype
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2348235
Beschrijving
Concomitant medication(s) specification
Datatype
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2348235
Beschrijving
Specification of other reason
Datatype
text
Alias
- UMLS CUI [1,1]
- C3840932
- UMLS CUI [1,2]
- C2348235
Beschrijving
Serious Adverse Event - Section 6 Medical Conditions
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0012634
Beschrijving
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
Datatype
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [2,1]
- C0020517
- UMLS CUI [2,2]
- C2347946
- UMLS CUI [3,1]
- C0543467
- UMLS CUI [3,2]
- C2347946
- UMLS CUI [4,1]
- C1519255
- UMLS CUI [4,2]
- C0681841
Beschrijving
Medical Condition Date of Onset
Datatype
date
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0574845
Beschrijving
Condition Present at Time of the SAE?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C1519255
Beschrijving
If not present at time of the SAE, Date of Last Occurrence
Datatype
date
Alias
- UMLS CUI [1,1]
- C2745955
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C0011008
Beschrijving
Serious Adverse Event - Section 7
Alias
- UMLS CUI-1
- C1519255
Beschrijving
Other RELEVANT Risk Factors
Datatype
text
Alias
- UMLS CUI [1,1]
- C0035648
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2347946
- UMLS CUI [2,1]
- C3714536
- UMLS CUI [2,2]
- C0241889
- UMLS CUI [3]
- C0543414
- UMLS CUI [4]
- C0001948
- UMLS CUI [5]
- C0012155
- UMLS CUI [6]
- C0013146
- UMLS CUI [7]
- C0337074
Beschrijving
Serious Adverse Event - Section 8 Relevant Concomitant Medication
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2347852
- UMLS CUI-3
- C2347946
Beschrijving
Trade Name preferred
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [1,3]
- C2347852
Beschrijving
Serious Adverse Event - Concomitant Medication Dose
Datatype
float
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C3174092
Beschrijving
Serious Adverse Event - Concomitant Medication Unit
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C1519795
Beschrijving
Serious Adverse Event - Concomitant Medication Frequency
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C3476109
Beschrijving
Serious Adverse Event - Concomitant Medication Route
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826730
Beschrijving
Serious Adverse Event - Concomitant Medication Taken prior to study?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C2603343
- UMLS CUI [1,4]
- C1883727
- UMLS CUI [1,5]
- C0332152
Beschrijving
Serious Adverse Event - Concomitant Medication Start Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826734
Beschrijving
Serious Adverse Event - Concomitant Medication Stop Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826744
Beschrijving
Serious Adverse Event - Concomitant Medication Ongoing?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826666
Beschrijving
Serious Adverse Event Reason - for Concomitant Medication
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826696
Beschrijving
Serious Adverse Event - Section 9
Alias
- UMLS CUI-1
- C1519255
Beschrijving
Was treatment blind broken at investigational site?
Alias
- UMLS CUI-1
- C3897431
Beschrijving
Serious Adverse Event - Section 10
Alias
- UMLS CUI-1
- C1519255
Beschrijving
Serious Adverse Event - Section 11
Alias
- UMLS CUI-1
- C1519255
Beschrijving
Serious Adverse Event - lnvestigator's signature
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2346576
Beschrijving
Confirming that the data on the SAE pages are accurate and complete
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
lnvestigator's name (print)
Datatype
text
Alias
- UMLS CUI [1]
- C2826892
Beschrijving
Signature Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
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C0806909 (UMLS CUI [1,3])
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C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
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C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C1710056 (UMLS CUI-2)
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0011298 (UMLS CUI-2)
C0034897 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C0012634 (UMLS CUI-2)
C2347946 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C2347946 (UMLS CUI [2,2])
C0543467 (UMLS CUI [3,1])
C2347946 (UMLS CUI [3,2])
C1519255 (UMLS CUI [4,1])
C0681841 (UMLS CUI [4,2])
C0574845 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2347946 (UMLS CUI [1,4])
C3714536 (UMLS CUI [2,1])
C0241889 (UMLS CUI [2,2])
C0543414 (UMLS CUI [3])
C0001948 (UMLS CUI [4])
C0012155 (UMLS CUI [5])
C0013146 (UMLS CUI [6])
C0337074 (UMLS CUI [7])
C2347852 (UMLS CUI-2)
C2347946 (UMLS CUI-3)
C1519255 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C3476109 (UMLS CUI [1,3])
C2826730 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C2603343 (UMLS CUI [1,3])
C1883727 (UMLS CUI [1,4])
C0332152 (UMLS CUI [1,5])
C2826734 (UMLS CUI [1,2])
C2826744 (UMLS CUI [1,2])
C2826666 (UMLS CUI [1,2])
C2826696 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,2])
C2346576 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])