ID

36916

Beschrijving

Study ID: 101468/201 Clinical Study ID: 101468/201 Study Title: 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 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 21 Visits(Days): Screening (at least 21 days before dosing) Week 1: including Day 1-7 Week 2: including Day 8-14 Week 3: including Day 15-19 Follow-up Visit (7-14 days after last dose) This document contains the Baseline Signs And Symptoms for Screening form.

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  1. 21-06-19 21-06-19 -
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GlaxoSmithKline

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21 juni 2019

DOI

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Creative Commons BY-NC 3.0
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Determination of starting dose and up-titration regimen for a new formulation of Ropinirole in healthy adults, 101468/201

Engels

Baseline Signs And Symptoms for Screening

1 Formulieren  
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Volunteer panel number
Beschrijving

identification number

Datatype

integer

Alias
UMLS CUI [1]
C1300638
Subject number
Beschrijving

Subject number

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Non-serious Adverse Event
Beschrijving

Non-serious Adverse Event

Alias
UMLS CUI-1
C1518404
Were baseline events experienced during the module?
Beschrijving

Non-serious Adverse Event

Datatype

boolean

Alias
UMLS CUI [1]
C1518404
Baseline sign/symptom
Beschrijving

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)

Datatype

text

Alias
UMLS CUI [1]
C0037088
Onset Date
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1]
C2985916
Onset Time
Beschrijving

00:00-23:59

Datatype

time

Alias
UMLS CUI [1,1]
C0449244
UMLS CUI [1,2]
C1518404
End Date
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1]
C2697886
End Time
Beschrijving

00:00-23:59

Datatype

time

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1522314
Outcome
Beschrijving

Outcome

Datatype

integer

Alias
UMLS CUI [1]
C1705586
Event course
Beschrijving

Experience Course

Datatype

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0750729
No. of episodes
Beschrijving

Number of episodes

Datatype

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C4086638
Intensity (maximum)
Beschrijving

MILD: An event which is easily tolerated MODERATE: An event which is sufficiently discomforting to interfere with daily activity SEVERE: An event which prevents normal everyday activities

Datatype

integer

Alias
UMLS CUI [1]
C1710066
Relationship to study procedures performed prior to randomisation
Beschrijving

NOT RELATED: The event is definitely not related to the study procedures UNLIKELY: There are other more likely causes and the study procedures are not suspected as a cause SUSPECTED (REASONABLE POSSIBILITY): A direct cause and effect relationship between the study procedures and the event has not been demonstrated but there is a reasonable possibility that the study procedures were involved PROBABLE: There probably is a direct cause and effect relationship between the event and the study procedures

Datatype

integer

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C2700391
Corrective Therapy
Beschrijving

If ‘Yes’, record details in the Concomitant Medication section and/or Healthcare Resource Utilisation form if appropriate

Datatype

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0087111
Was patient withdrawn due to this specific AE?
Beschrijving

patient withdrawn due to this specific AE

Datatype

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C1518404
Investigator signature:
Beschrijving

Investigator signature

Datatype

text

Alias
UMLS CUI [1]
C2346576
Date:
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1]
C0011008
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Similar models

Baseline Signs And Symptoms for Screening

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
identification number
Item
Volunteer panel number
integer
C1300638 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Non-serious Adverse Event
C1518404 (UMLS CUI-1)
Non-serious Adverse Event
Item
Were baseline events experienced during the module?
boolean
C1518404 (UMLS CUI [1])
Baseline sign symptom
Item
Baseline sign/symptom
text
C0037088 (UMLS CUI [1])
Onset Date
Item
Onset Date
date
C2985916 (UMLS CUI [1])
Onset Time
Item
Onset Time
time
C0449244 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
End Date
Item
End Date
date
C2697886 (UMLS CUI [1])
End Time
Item
End Time
time
C1518404 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
Outcome
integer
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome
CL Item
Resolved (1)
CL Item
Ongoing (2)
CL Item
Died (3)
Item
Event course
integer
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Experience Course
Code List
Event course
CL Item
Intermittent (1)
CL Item
Constant (2)
Number of episodes
Item
No. of episodes
integer
C0877248 (UMLS CUI [1,1])
C4086638 (UMLS CUI [1,2])
Item
Intensity (maximum)
integer
C1710066 (UMLS CUI [1])
Intensity
Code List
Intensity (maximum)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Relationship to study procedures performed prior to randomisation
integer
C0008976 (UMLS CUI [1,1])
C2700391 (UMLS CUI [1,2])
Relationship to Investigational Drug
Code List
Relationship to study procedures performed prior to randomisation
CL Item
Not related (1)
CL Item
Unlikely  (2)
CL Item
Suspected  (3)
CL Item
Probable (4)
Item
Corrective Therapy
text
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Corrective Therapy
Code List
Corrective Therapy
CL Item
Yes (Y)
CL Item
No (N)
Item
Was patient withdrawn due to this specific AE?
text
C0422727 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
patient withdrawn due to this specific AE
Code List
Was patient withdrawn due to this specific AE?
CL Item
Yes (Y)
CL Item
No (N)
Investigator signature
Item
Investigator signature:
text
C2346576 (UMLS CUI [1])
Date
Item
Date:
date
C0011008 (UMLS CUI [1])
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