ID
39305
Descripción
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.
Palabras clave
Versiones (1)
- 18/12/19 18/12/19 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
18 de diciembre de 2019
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
Creative Commons BY-NC 3.0
Comentarios del modelo :
Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.
Comentarios de grupo de elementos para :
Comentarios del elemento para :
Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.
Brain Penetration by [Carbonyl-11C] GSK1034702; 110771
Serious Adverse Event (SAE)
- StudyEvent: ODM
Descripción
Section 1
Alias
- UMLS CUI-1
- C1519255
Descripción
Serious Adverse Event
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1519255
Descripción
Serious Adverse Event
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1519255
Descripción
Serious Adverse Event, Start Date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0808070
Descripción
Serious Adverse Event, Start Time
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1301880
Descripción
Serious Adverse Event, Adverse Event Outcome
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1705586
Descripción
Serious Adverse Event, End Date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0806020
Descripción
Serious Adverse Event, End Time
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1522314
Descripción
Serious Adverse Event, Grade, Maximum; Serious Adverse Event, Symptom Intensity, Maximum
Tipo de datos
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
Descripción
Serious Adverse Event, Action Taken with Study Treatment
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1704758
Descripción
Serious Adverse Event, Withdraw
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2349954
Descripción
Serious Adverse Event, Relationships, Experimental drug
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0439849
- UMLS CUI [1,3]
- C0304229
Descripción
Serious Adverse Event, Fatal, Autopsy
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1302234
- UMLS CUI [1,3]
- C0004398
Descripción
Section 2: Seriousness
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C1710056
Descripción
Serious Adverse Event, Seriousness of Adverse Event
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1710056
Descripción
Serious Adverse Event, Seriousness of Adverse Event
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1710056
Descripción
Serious 3: Demography Data
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0011298
Descripción
Serious Adverse Event, Patient date of birth
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0421451
Descripción
Serious Adverse Event, Gender
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0079399
Descripción
Serious Adverse Event, Body Weight
Tipo de datos
float
Unidades de medida
- kg
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0005910
Descripción
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
Descripción
Section 5: Possible Causes of SAE Other Than Investigational Product(s)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0015127
Descripción
Serious Adverse Event, Etiology aspects
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0015127
Descripción
Serious Adverse Event, Etiology aspects
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0015127
Descripción
Section 6: Relevant Medical Conditions
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0012634
Descripción
Serious Adverse Event, Disease; Serious Adverse Event, Hypersensitivity; Serious Adverse Event, Operative Surgical Procedures
Tipo de datos
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
Descripción
Serious Adverse Event, Disease, Start Date; Serious Adverse Event, Hypersensitivity, Start Date; Serious Adverse Event, Operative Surgical Procedures, Start Date
Tipo de datos
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
Descripción
Serious Adverse Event, Disease, Present; Serious Adverse Event, Hypersensitivity, Present; Serious Adverse Event, Operative Surgical Procedures, Present
Tipo de datos
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
Descripción
Serious Adverse Event, Disease, End Date; Serious Adverse Event, Hypersensitivity, End Date; Serious Adverse Event, Operative Surgical Procedures, End Date
Tipo de datos
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
Descripción
Section 7: Other Relevant Risk Factors
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0035648
Descripción
Section 8: Relevant Concomitant Medications
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2347852
Descripción
Serious Adverse Event, Concomitant Agent, Medication name
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C2360065
Descripción
Serious Adverse Event, Concomitant Agent, Dosage
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0178602
Descripción
Serious Adverse Event, Concomitant Agent, Unit of Measure
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C1519795
Descripción
Serious Adverse Event, Concomitant Agent, Frequencies
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0439603
Descripción
Serious Adverse Event, Concomitant Agent, Drug Administration Routes
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0013153
Descripción
Serious Adverse Event, Concomitant Medication Previous Occurrence
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826667
Descripción
Serious Adverse Event, Concomitant Medication Start Date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826734
Descripción
Serious Adverse Event, Concomitant Medication End Date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826744
Descripción
Serious Adverse Event, Concomitant Medication Ongoing
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826666
Descripción
Serious Adverse Event, Concomitant Agent, Reason and justification
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0566251
Descripción
Section 9: Details of Investigational Product(s)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0304229
- UMLS CUI-3
- C1522508
Descripción
Section 10: Details of Relevant Assessments
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0430022
Descripción
Section 11: Narrative Remarks
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0947611
Descripción
Investigator's Signature
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2346576
Descripción
Serious Adverse Event, Investigator Signature
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2346576
Descripción
Serious Adverse Event, Investigator Signature, Date in time
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2346576
- UMLS CUI [1,3]
- C0011008
Descripción
Serious Adverse Event, Investigator Name
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826892
Similar models
Serious Adverse Event (SAE)
- StudyEvent: ODM
C1300638 (UMLS CUI [1,2])
C0237753 (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])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2,1])
C0518690 (UMLS CUI [2,2])
C0806909 (UMLS CUI [2,3])
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])
C1710056 (UMLS CUI-2)
C1710056 (UMLS CUI [1,2])
C1710056 (UMLS CUI [1,2])
C0011298 (UMLS CUI-2)
C0421451 (UMLS CUI [1,2])
C0005910 (UMLS CUI [1,2])
C0439849 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0015127 (UMLS CUI-2)
C0015127 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,2])
C0012634 (UMLS CUI-2)
C0012634 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0020517 (UMLS CUI [2,2])
C1519255 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
C0012634 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2,1])
C0020517 (UMLS CUI [2,2])
C0808070 (UMLS CUI [2,3])
C1519255 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
C0808070 (UMLS CUI [3,3])
C0012634 (UMLS CUI [1,2])
C0150312 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2,1])
C0020517 (UMLS CUI [2,2])
C0150312 (UMLS CUI [2,3])
C1519255 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
C0150312 (UMLS CUI [3,3])
C0012634 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2,1])
C0020517 (UMLS CUI [2,2])
C0806020 (UMLS CUI [2,3])
C1519255 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
C0806020 (UMLS CUI [3,3])
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])
C0178602 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C1519795 (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])
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])