ID

38778

Descrição

Study ID: 109035 Clinical Study ID: 109035 Study Title: A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy and Safety of GSK163090 in Subjects With Major Depressive Disorder Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00896363 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GSK163090 1 mg, GSK163090 Placebo, GSK163090 3 mg Trade Name: Study Indication: Depressive Disorder

Palavras-chave

Versões (1)
  1. 03/11/2019 03/11/2019 -
Titular dos direitos

GlaxoSmithKline

Transferido a

3 de novembro de 2019

DOI

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Licença

Creative Commons BY-NC 3.0
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Efficacy and Safety of GSK163090 in Subjects with Major Depressive Disorder; NCT00896363

Inglês

Non-Serious Adverse Event - Repeating Form

1 Formulários  
Non-Serious Adverse Event
Descrição

Non-Serious Adverse Event

Alias
UMLS CUI-1
C1518404
Sequence Number
Descrição

Non-serious Adverse Event, Sequence Number

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C2348184
Event
Descrição

Non-serious Adverse Event

Tipo de dados

text

Alias
UMLS CUI [1]
C1518404
Modified term
Descrição

Non-serious Adverse Event, Adverse Event Modified Reported Term

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C2826798
MedDRA synonym
Descrição

Non-serious Adverse Event, Medical Dictionary for Regulatory Activities Terminology (MedDRA), Synonym

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1140263
UMLS CUI [1,3]
C0871468
MedDRA lower level term code
Descrição

Non-serious Adverse Event, MedDRA Low Level Term Code

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C3898442
Failed coding
Descrição

Non-serious Adverse Event, Code, Failed

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0805701
UMLS CUI [1,3]
C0231175
Start Date and Time
Descrição

Non-serious Adverse Event, Start Date, Start time

Tipo de dados

datetime

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0808070
UMLS CUI [1,3]
C1301880
Outcome
Descrição

Non-serious Adverse Event, Adverse Event Outcome

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1705586
End Date and Time
Descrição

Non-serious Adverse Event, End date, End Time

Tipo de dados

datetime

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0806020
UMLS CUI [1,3]
C1522314
Frequency
Descrição

Non-serious Adverse Event, Frequencies

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0439603
Maximum Intensity
Descrição

Non-serious Adverse Event, Symptom intensity, Maximum

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0806909
Maximum Grade
Descrição

Non-serious Adverse Event, Grade, Maximum

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0806909
Maximum Grade or Intensity
Descrição

Non-serious Adverse Event, Grade, Symptom intensity, Maximum

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0518690
UMLS CUI [1,4]
C0806909
Action Taken with Investigational product(s) as a Result of the AE
Descrição

Non-serious Adverse Event, Action Taken with Study Treatment

Tipo de dados

text

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

Non-serious Adverse Event, Withdraw

Tipo de dados

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?
Descrição

Non-serious Adverse Event, Relationships, Experimental drug

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0304229
Duration of AE if < 24 hours
Descrição

Non-serious Adverse Event, Duration

Tipo de dados

integer

Unidades de medida
  • hours
Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C2926735
hours
Time to Onset Since Last Dose
Descrição

Non-serious Adverse Event, Time of Onset, Time Last Dose

Tipo de dados

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449244
UMLS CUI [1,3]
C0946444
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Similar models

Non-Serious Adverse Event - Repeating Form

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Non-Serious Adverse Event
C1518404 (UMLS CUI-1)
Non-serious Adverse Event, Sequence Number
Item
Sequence Number
integer
C1518404 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Non-serious Adverse Event
Item
Event
text
C1518404 (UMLS CUI [1])
Non-serious Adverse Event, Adverse Event Modified Reported Term
Item
Modified term
text
C1518404 (UMLS CUI [1,1])
C2826798 (UMLS CUI [1,2])
Non-serious Adverse Event, Medical Dictionary for Regulatory Activities Terminology (MedDRA), Synonym
Item
MedDRA synonym
text
C1518404 (UMLS CUI [1,1])
C1140263 (UMLS CUI [1,2])
C0871468 (UMLS CUI [1,3])
Non-serious Adverse Event, MedDRA Low Level Term Code
Item
MedDRA lower level term code
text
C1518404 (UMLS CUI [1,1])
C3898442 (UMLS CUI [1,2])
Non-serious Adverse Event, Code, Failed
Item
Failed coding
text
C1518404 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Non-serious Adverse Event, Start Date, Start time
Item
Start Date and Time
datetime
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
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, provide End Date and Time (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolved with sequelae, provide End Date and Time (4)
Non-serious Adverse Event, End date, End Time
Item
End Date and Time
datetime
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
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 Intensity
text
C1518404 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Non-serious Adverse Event, Frequencies
Code List
Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (4)
Item
Maximum Grade
text
C1518404 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Non-serious Adverse Event, Grade, Maximum
Code List
Maximum Grade
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 2 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
CL Item
Not applicable (6)
Item
Maximum Grade or Intensity
text
C1518404 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
C0806909 (UMLS CUI [1,4])
Non-serious Adverse Event, Grade, 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 2 (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 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 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 the 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])
Non-serious Adverse Event, Duration
Item
Duration of AE if < 24 hours
integer
C1518404 (UMLS CUI [1,1])
C2926735 (UMLS CUI [1,2])
Non-serious Adverse Event, Time of Onset, Time Last Dose
Item
Time to Onset Since Last Dose
time
C1519255 (UMLS CUI [1,1])
C0449244 (UMLS CUI [1,2])
C0946444 (UMLS CUI [1,3])
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