ID

20685

Beschrijving

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

Trefwoorden

Versies (2)
  1. 10-03-17 10-03-17 -
  2. 10-03-17 10-03-17 -
Geüploaded op

10 maart 2017

DOI

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Licentie

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

Engels

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

1 Formulieren  
Subject Information
Beschrijving

Subject Information

Alias
UMLS CUI-1
C2707520
Subject Identifier
Beschrijving

Subject Identifier

Datatype

text

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

Non-Serious Adverse Events (AE)

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

If Yes, record details below.

Datatype

boolean

Alias
UMLS CUI [1]
C1518404
Event
Beschrijving

Diagnosis Only (if known) Otherwise Sign/Symptom

Datatype

text

Alias
UMLS CUI [1]
C0877248
Start Date
Beschrijving

Start Date

Datatype

date

Maateenheden
  • Day Month Year
Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0877248
Day Month Year
Start Time
Beschrijving

Start Time

Datatype

time

Maateenheden
  • Hr : Min
Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C0877248
Hr : Min
Outcome
Beschrijving

Outcome

Datatype

text

Alias
UMLS CUI [1]
C1705586
End Date
Beschrijving

End Date

Datatype

date

Maateenheden
  • Day Month Year
Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0806020
Day Month Year
End Time
Beschrijving

End Time

Datatype

time

Maateenheden
  • Hr : Min
Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C0877248
Hr : Min
Frequency
Beschrijving

Frequency

Datatype

text

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

Maximum Intensity

Datatype

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
Beschrijving

Action Taken with Investigational Product

Datatype

text

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

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

Datatype

text

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

Relationship to Investigational Product(s)

Datatype

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 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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