ID

39304

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.

Mots-clés

Versions (1)
  1. 18/12/2019 18/12/2019 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

18 décembre 2019

DOI

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Licence

Creative Commons BY-NC 3.0
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Brain Penetration by [Carbonyl-11C] GSK1034702; 110771

Anglais

Non-Serious Adverse Events (AE)

1 Formulaires  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Clinical Trial Subject Unique Identifier

Type de données

integer

Alias
UMLS CUI [1]
C2348585
Non-Serious Adverse Events (AE)
Description

Non-Serious Adverse Events (AE)

Alias
UMLS CUI-1
C1518404
Did the subject experience any non-serious adverse events during the study?
Description

Non-serious Adverse Event

Type de données

boolean

Alias
UMLS CUI [1]
C1518404
Event - Diagnosis Only (if known) Otherwise Sign/Symptom
Description

Non-serious Adverse Event

Type de données

text

Alias
UMLS CUI [1]
C1518404
Start Date
Description

Non-serious Adverse Event, Start Date

Type de données

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0808070
Start Time
Description

Non-serious Adverse Event, Start Time

Type de données

time

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1301880
Outcome
Description

Non-serious Adverse Event, Adverse Event Outcome

Type de données

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1705586
End Date
Description

Non-serious Adverse Event, End Date

Type de données

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0806020
End Time
Description

Non-serious Adverse Event, End Time

Type de données

time

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1522314
Frequency
Description

Non-serious Adverse Event, Frequencies

Type de données

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0439603
Maximum Grade or Intensity
Description

Non-serious Adverse Event, Grade, Maximum;Non-serious Adverse Event, Symptom Intensity, Maximum

Type de données

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0806909
UMLS CUI [2,1]
C1518404
UMLS CUI [2,2]
C0518690
UMLS CUI [2,3]
C0806909
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
Description

Non-serious Adverse Event, Action Taken with Study Treatment

Type de données

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1704758
Did the subject withdraw from study as a result of this AE?
Description

Non-serious Adverse Event, Withdraw

Type de données

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C2349954
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Description

Non-serious Adverse Event, Relationships, Experimental drug

Type de données

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0304229
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Similar models

Non-Serious Adverse Events (AE)

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item Group
Non-Serious Adverse Events (AE)
C1518404 (UMLS CUI-1)
Non-serious Adverse Event
Item
Did the subject experience any non-serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1])
Non-serious Adverse Event
Item
Event - Diagnosis Only (if known) Otherwise Sign/Symptom
text
C1518404 (UMLS CUI [1])
Non-serious Adverse Event, Start Date
Item
Start Date
date
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Non-serious Adverse Event, Start Time
Item
Start Time
time
C1518404 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Item
Outcome
text
C1518404 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Non-serious Adverse Event, Adverse Event Outcome
Code List
Outcome
CL Item
Recovered/ Resolved  (1)
CL Item
Recovering/ Resolving (2)
CL Item
Not recovered/ Not resolved (3)
CL Item
Recovered/ Resolved with sequelae (4)
Non-serious Adverse Event, End Date
Item
End Date
date
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Non-serious Adverse Event, End Time
Item
End Time
time
C1518404 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
Frequency
text
C1518404 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Non-serious Adverse Event, Frequencies
Code List
Frequency
CL Item
Single episode  (1)
CL Item
Intermittent (2)
Item
Maximum Grade or Intensity
text
C1518404 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C1518404 (UMLS CUI [2,1])
C0518690 (UMLS CUI [2,2])
C0806909 (UMLS CUI [2,3])
Non-serious Adverse Event, Symptom Intensity, Maximum
Code List
Maximum Grade or Intensity
CL Item
Mild or Grade 1 (1)
CL Item
Moderate or Grade 2 (2)
CL Item
Severe or Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
CL Item
Not applicable (6)
Item
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
text
C1518404 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])
Non-serious Adverse Event, Action Taken with Study Treatment
Code List
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
CL Item
Investigational product(s) withdrawn  (1)
CL Item
Dose reduced  (2)
CL Item
Dose increased  (3)
CL Item
Dose not changed  (4)
CL Item
Dose interrupted  (5)
CL Item
Not applicable (6)
Non-serious Adverse Event, Withdraw
Item
Did the subject withdraw from study as a result of this AE?
boolean
C1518404 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
Non-serious Adverse Event, Relationships, Experimental drug
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C1518404 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
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