ID
36088
Description
Study ID: 101468/198 Clinical Study ID: 101468/198 Study Title:An open, randomised, crossover, healthy volunteer study to compare the PK and tolerability of ropinirole as 3 different new formulations with the standard marketed formulation and to study the effects of a high fat meal on a new formulation Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A 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 The Study consists of a Screening, 5 Sessions each with 2 days and a Follow-up. This document contains the Baseline Sign and Symptom form. It has to be filled in for screening.
Keywords
Versions (2)
- 4/15/19 4/15/19 -
- 4/15/19 4/15/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
April 15, 2019
DOI
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License
Creative Commons BY-NC 3.0
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Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198
Baseline Sign and Symptom
- StudyEvent: ODM
Description
No event
Description
Adverse Event
Alias
- UMLS CUI-1
- C0877248
Description
Record any Baseline events (using standard medical terminology) observed or elicited by the following direct question to the subject: "How do you feel?" Provide the diagnosis NOT symptoms where possible. (One Baseline event per column)
Data type
text
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C1442488
Description
day month year
Data type
date
Alias
- UMLS CUI [1]
- C2985916
Description
00:00-23:59
Data type
time
Alias
- UMLS CUI [1,1]
- C0449244
- UMLS CUI [1,2]
- C0877248
Description
day month year (If ongoing, please leave blank)
Data type
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0877248
Description
00:00-23:59 (If ongoing, please leave blank)
Data type
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C0877248
Description
If subject died, please inform GSK within 24 hours and complete form D
Data type
integer
Alias
- UMLS CUI [1]
- C1705586
Description
Event Course
Data type
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
Description
No. of Episodes
Data type
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C4086638
Description
MILD: Adverse Event which is easily tolerated. MODERATE: Adverse Event sufficiently discomforting to interfere with daily activity. SEVERE: Adverse Event which prevents normal everyday activities.
Data type
integer
Alias
- UMLS CUI [1]
- C1710066
Description
NOT RELATED: The adverse event is definitely not related to the test drug. UNLIKELY: There are more likely causes and the drug is not suspected as a cause. SUSPECTED (REASONABLE POSSIBILITY): A direct cause and effect relationship between the drug and the adverse event has not been demonstrated but there is a reasonable possibility that the event was caused by the drug. PROBABLE: There is probably a direct cause and effect relationship between the adverse event and the study drug.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1510821
Description
If you tick yes, please record on Prior Medication form.
Data type
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0087111
Description
Subject withdrawn
Data type
text
Alias
- UMLS CUI [1]
- C0422727
Description
Investigator's Signature
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
day month year
Data type
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Similar models
Baseline Sign and Symptom
- StudyEvent: ODM
C1442488 (UMLS CUI [1,2])
C1442488 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
C4086638 (UMLS CUI [1,2])
C1510821 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
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