ID

20685

Descrição

Documentation Part: Non-Serious Adverse Events (AE) An Open Label, Repeat Dose, Dose Escalation Study Conducted in Parkinson's Disease Patients to Characterize the Pharmacokinetics and Effect of Food on Ropinirole Prolonged Release (PR/CR) 12mg Tablets. ClinicalTrials.gov Identifier: NCT00460148 https://clinicaltrials.gov/ct2/show/NCT00460148?term=NCT00460148&rank=1 Responsible Party: GlaxoSmithKline

Link

https://clinicaltrials.gov/ct2/show/NCT00460148?term=NCT00460148&rank=1

Palavras-chave

Versões (2)
  1. 10/03/2017 10/03/2017 -
  2. 10/03/2017 10/03/2017 -
Transferido a

10 de março de 2017

DOI

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Licença

Creative Commons BY-NC 3.0
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Non-Serious Adverse Events (AE) Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148

Inglês

Non-Serious Adverse Events (AE) Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148

1 Formulários  
Subject Information
Descrição

Subject Information

Alias
UMLS CUI-1
C2707520
Subject Identifier
Descrição

Subject Identifier

Tipo de dados

text

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

Non-Serious Adverse Events (AE)

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

If Yes, record details below.

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1518404
Event
Descrição

Diagnosis Only (if known) Otherwise Sign/Symptom

Tipo de dados

text

Alias
UMLS CUI [1]
C0877248
Start Date
Descrição

Start Date

Tipo de dados

date

Unidades de medida
  • Day Month Year
Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0877248
Day Month Year
Start Time
Descrição

Start Time

Tipo de dados

time

Unidades de medida
  • Hr : Min
Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C0877248
Hr : Min
Outcome
Descrição

Outcome

Tipo de dados

text

Alias
UMLS CUI [1]
C1705586
End Date
Descrição

End Date

Tipo de dados

date

Unidades de medida
  • Day Month Year
Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0806020
Day Month Year
End Time
Descrição

End Time

Tipo de dados

time

Unidades de medida
  • Hr : Min
Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C0877248
Hr : Min
Frequency
Descrição

Frequency

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0439603
UMLS CUI [1,2]
C0877248
Maximum Intensity
Descrição

Maximum Intensity

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C0877248
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
Descrição

Action Taken with Investigational Product

Tipo de dados

text

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

Did the subject withdraw from study as a result of this AE?

Tipo de dados

text

Alias
UMLS CUI [1]
C0422727
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Descrição

Relationship to Investigational Product(s)

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0085978
UMLS CUI [1,2]
C0877248
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Similar models

Non-Serious Adverse Events (AE) Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Subject Information
C2707520 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item Group
Non-Serious Adverse Events (AE)
C1518404 (UMLS CUI-1)
Did the subject experience any non-serious adverse events during the study?
Item
Did the subject experience any non-serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1])
Event
Item
Event
text
C0877248 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Start Time
Item
Start Time
time
C1301880 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item
Outcome
text
C1705586 (UMLS CUI [1])
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)
End Date
Item
End Date
date
C0877248 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
End Time
Item
End Time
time
C1522314 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item
Frequency
text
C0439603 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Frequency
Code List
Frequency
CL Item
Single episode (1)
CL Item
Intermittent (2)
Item
Maximum Intensity
text
C0518690 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Maximum Intensity
Code List
Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
Item
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
text
C1704758 (UMLS CUI [1])
Action Taken with Investigational Product
Code List
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
CL Item
Investigational product(s) (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)
Item
Did the subject withdraw from study as a result of this AE?
text
C0422727 (UMLS CUI [1])
Did the subject withdraw from study as a result of this AE?
Code List
Did the subject withdraw from study as a result of this AE?
CL Item
Yes (Y)
CL Item
No (N)
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
text
C0085978 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Relationship to Investigational Product(s)
Code List
Is there a reasonable possibility that the AE may have been caused by the investigational product?
CL Item
Yes (Y)
CL Item
No (N)
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