ID

20685

Beschreibung

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

Stichworte

Versionen (2)
  1. 10.03.17 10.03.17 -
  2. 10.03.17 10.03.17 -
Hochgeladen am

10. März 2017

DOI

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Lizenz

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

Englisch

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

1 Formulare  
Subject Information
Beschreibung

Subject Information

Alias
UMLS CUI-1
C2707520
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

text

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

Non-Serious Adverse Events (AE)

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

If Yes, record details below.

Datentyp

boolean

Alias
UMLS CUI [1]
C1518404
Event
Beschreibung

Diagnosis Only (if known) Otherwise Sign/Symptom

Datentyp

text

Alias
UMLS CUI [1]
C0877248
Start Date
Beschreibung

Start Date

Datentyp

date

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

Start Time

Datentyp

time

Maßeinheiten
  • Hr : Min
Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C0877248
Hr : Min
Outcome
Beschreibung

Outcome

Datentyp

text

Alias
UMLS CUI [1]
C1705586
End Date
Beschreibung

End Date

Datentyp

date

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

End Time

Datentyp

time

Maßeinheiten
  • Hr : Min
Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C0877248
Hr : Min
Frequency
Beschreibung

Frequency

Datentyp

text

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

Maximum Intensity

Datentyp

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
Beschreibung

Action Taken with Investigational Product

Datentyp

text

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

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

Datentyp

text

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

Relationship to Investigational Product(s)

Datentyp

text

Alias
UMLS CUI [1,1]
C0085978
UMLS CUI [1,2]
C0877248
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Ähnliche Modelle

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

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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