ID
25640
Description
Study part: Serious Adverse Events (SAE). A Single Blind, Parallel Group, Up-titration, Phase 1 Study in Healthy Volunteers to Determine a Starting Dose and Select an Up-titration Regimen for a new Formulation of Ropinirole. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Phase: phase 1. Study Recruitment Status: Completed Generic Name: ropinirole. Trade Name: Modutab, ZIPEREVE, ZEPREVE, REPREVE, ADARTREL, REQUIP, Zygara; Zygara, ZIPEREVE, ZEPREVE, Requip Depot, REQUIP, REPREVE, Modutab, ADARTREL. Study Indication : Restless Legs Syndrome. Study ID: 101468/201. Clinical Study ID: 101468/201
Keywords
Versions (2)
- 9/8/17 9/8/17 -
- 5/10/19 5/10/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
September 8, 2017
DOI
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License
Creative Commons BY-NC 3.0
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Serious Adverse Events (SAE) Ropinirole Restless Legs Syndrome 101468/201
Serious Adverse Experiences (SAE)
- StudyEvent: ODM
Description
RELEVANT LABORATORY DATA
Alias
- UMLS CUI-1
- C0022877
Description
Test
Data type
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0332307
Description
Date
Data type
text
Alias
- UMLS CUI [1]
- C0011008
Description
Value
Data type
text
Alias
- UMLS CUI [1]
- C1522609
Description
Units
Data type
text
Alias
- UMLS CUI [1]
- C1519795
Description
Normal Range
Data type
text
Alias
- UMLS CUI [1]
- C0086715
Description
Remarks
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
randomisation code broken
Data type
boolean
Alias
- UMLS CUI [1,1]
- C3897778
- UMLS CUI [1,2]
- C1272691
Description
Randomisation Number
Data type
integer
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
Description
Investigators Signature
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
Date
Data type
date
Alias
- UMLS CUI [1]
- C0011008
Description
name
Data type
text
Alias
- UMLS CUI [1]
- C0027365
Description
Medical Monitor’s Signature
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
Name
Data type
text
Alias
- UMLS CUI [1]
- C0027365
Description
Date
Data type
date
Alias
- UMLS CUI [1]
- C0011008
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- StudyEvent: ODM
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