ID

20679

Description

Documentation Part: Investigational Product Discontinuation 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

Keywords

Versions (2)
  1. 3/9/17 3/9/17 -
  2. 3/10/17 3/10/17 -
Uploaded on

March 10, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Investigational Product Discontinuation Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148

English

Investigational Product Discontinuation Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148

1 forms  
Subject information
Description

Subject information

Alias
UMLS CUI-1
C2707520
Subject identifier
Description

Subject identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Investigational Product Discontinuation
Description

Investigational Product Discontinuation

Alias
UMLS CUI-1
C0013230
UMLS CUI-2
C0457454
Was the investigational product stopped permanently before the end of the scheduled treatment period?
Description

Was the investigational product stopped permanently before the end of the scheduled treatment period?

Data type

text

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0457454
If Yes, check the primary reason the investigational product was stopped:
Description

If Yes, check the primary reason the investigational product was stopped:

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0457454
If other, specify:
Description

If other, specify:

Data type

text

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0457454
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Similar models

Investigational Product Discontinuation Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Subject information
C2707520 (UMLS CUI-1)
Subject identifier
Item
Subject identifier
text
C2348585 (UMLS CUI [1])
Item Group
Investigational Product Discontinuation
C0013230 (UMLS CUI-1)
C0457454 (UMLS CUI-2)
Item
Was the investigational product stopped permanently before the end of the scheduled treatment period?
text
C0013230 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
Code List
Was the investigational product stopped permanently before the end of the scheduled treatment period?
CL Item
Yes (Y)
CL Item
No (N)
Item
If Yes, check the primary reason the investigational product was stopped:
text
C0392360 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0457454 (UMLS CUI [1,3])
If Yes, check the primary reason the investigational product was stopped:
Code List
If Yes, check the primary reason the investigational product was stopped:
CL Item
Adverse event (Record details on the Non-Serious Adverse Events or Serious Adverse Event pages as appropriate.) (1)
CL Item
Lost to follow-up (2)
CL Item
Protocol violation (3)
CL Item
Subject decided to withdraw from the study (4)
CL Item
Sponsor terminated study (6)
CL Item
Other (Z)
If other, specify:
Item
If other, specify:
text
C2348235 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0457454 (UMLS CUI [1,3])
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