ID

36084

Description

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 (Day 0) Week 1: including Day 1-7 Week 2: including Day 8-14 Week 3: including Day 15-19 Follow-up Visit (Day 21) This document contains the Baseline Sign and Symptom form. It has to be filled in for screening.

Keywords

Versions (2)
  1. 4/15/19 4/15/19 -
  2. 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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Determination of starting dose and up-titration regimen for a new formulation of Ropinirole, 101468/201

English

Baseline Sign and Symptom

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject No.
Description

Subject No.

Data type

text

Alias
UMLS CUI [1]
C2348585
Panel ID
Description

Panel ID

Data type

text

Alias
UMLS CUI [1]
C3846158
Visit Date
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C1320303
No event
Description

No event

If no baseline events experienced, please mark box and sign form below.
Description

No baseline event experienced

Data type

boolean

Alias
UMLS CUI [1,1]
C3846032
UMLS CUI [1,2]
C1442488
Adverse Event
Description

Adverse Event

Alias
UMLS CUI-1
C0877248
Baseline Sign/Symptom
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
Onset Date
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C2985916
Onset Time
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0449244
UMLS CUI [1,2]
C0877248
End Date
Description

day month year (If ongoing, please leave blank)

Data type

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0877248
End Time
Description

00:00-23:59 (If ongoing, please leave blank)

Data type

time

Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C0877248
Outcome of AE
Description

If subject died, please inform GSK within 24 hours and complete form D

Data type

integer

Alias
UMLS CUI [1]
C1705586
Event Course
Description

Event Course

Data type

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0750729
If event course is intermittent, please note No. of Episodes
Description

No. of Episodes

Data type

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C4086638
Intensity of AE
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
Relationship to Study Procedures performed prior to randomisation
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
Corrective Therapy
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
Was the subject withdrawn due to this event?
Description

Subject withdrawn

Data type

text

Alias
UMLS CUI [1]
C0422727
Investigator's Signature:
Description

Investigator's Signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Date of signature
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Similar models

Baseline Sign and Symptom

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject No.
Item
Subject No.
text
C2348585 (UMLS CUI [1])
Panel ID
Item
Panel ID
text
C3846158 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
No event
No baseline event experienced
Item
If no baseline events experienced, please mark box and sign form below.
boolean
C3846032 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
Item Group
Adverse Event
C0877248 (UMLS CUI-1)
Baseline Sign/Symptom
Item
Baseline Sign/Symptom
text
C0037088 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
Onset Date
Item
Onset Date
date
C2985916 (UMLS CUI [1])
Onset Time
Item
Onset Time
time
C0449244 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
End Time
Item
End Time
time
C1522314 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item
Outcome of AE
integer
C1705586 (UMLS CUI [1])
Outcome of AE
Code List
Outcome of AE
CL Item
Resolved (1)
CL Item
Ongoing (2)
CL Item
Died (2)
Item
Event Course
integer
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Event Course
Code List
Event Course
CL Item
Intermittent (1)
CL Item
Constant (2)
No. of Episodes
Item
If event course is intermittent, please note No. of Episodes
integer
C0877248 (UMLS CUI [1,1])
C4086638 (UMLS CUI [1,2])
Item
Intensity of AE
integer
C1710066 (UMLS CUI [1])
Intensity of AE
Code List
Intensity of AE
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Relationship to Study Procedures performed prior to randomisation
integer
C0877248 (UMLS CUI [1,1])
C1510821 (UMLS CUI [1,2])
Relationship to Study Procedures
Code List
Relationship to Study Procedures performed prior to randomisation
CL Item
Not related (1)
CL Item
Unlikely (2)
CL Item
Suspected (reasonable possibility) (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 the subject withdrawn due to this event?
text
C0422727 (UMLS CUI [1])
Subject withdrawn
Code List
Was the subject withdrawn due to this event?
CL Item
Yes (Y)
CL Item
No (N)
Investigator's Signature
Item
Investigator's Signature:
text
C2346576 (UMLS CUI [1])
Date of signature
Item
Date of signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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