ID

36029

Beschrijving

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 AE form. It has to be filled in if the subject experienced an AE during the study trial.

Trefwoorden

Versies (1)
  1. 09-04-19 09-04-19 -
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GlaxoSmithKline

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9 april 2019

DOI

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Creative Commons BY-NC 3.0
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Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198

Engels

Adverse Events

1 Formulieren  
  1. StudyEvent: ODM
    1. Adverse Events
Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Subject No.
Beschrijving

Subject No.

Datatype

text

Alias
UMLS CUI [1]
C2348585
Panel ID
Beschrijving

Panel ID

Datatype

text

Alias
UMLS CUI [1]
C3846158
Adverse Event
Beschrijving

Adverse Event

Alias
UMLS CUI-1
C0877248
If no adverse event, please mark box and sign form below.
Beschrijving

No adverse event

Datatype

boolean

Adverse Event
Beschrijving

Record any Adverse events (using standard medical terminology) observed or elicited by the following direct question to the subject: "Have you felt different in any way since starting the new treatment or since the last visit?" Provide the diagnosis NOT symptoms where possible. (One adverse event per column)

Datatype

text

Alias
UMLS CUI [1]
C0877248
Comment for GSK
Beschrijving

Comment for GSK

Datatype

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0947611
UMLS CUI [1,3]
C0008961
AE Onset Date
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1]
C2985916
AE Onset Time
Beschrijving

00:00-23:59

Datatype

time

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

day month year (If ongoing, please leave blank)

Datatype

date

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

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

Datatype

time

Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C0877248
Outcome
Beschrijving

Outcome

Datatype

integer

Alias
UMLS CUI [1]
C1705586
AE Event Course
Beschrijving

AE Event Course

Datatype

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0750729
If event course intermittent, please note the number of episodes
Beschrijving

Number of Episodes

Datatype

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C4086638
AE 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
Action taken with respect to investigational drug
Beschrijving

Action taken with respect to investigational drug

Datatype

integer

Alias
UMLS CUI [1]
C2826626
Relationship to Investigational Drug
Beschrijving

NOT RELATED: The event is definitely not related to the study procedured 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]
C1518404
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
Corrective Therapy
Beschrijving

If "Yes", please record on Concomitant Medication form.

Datatype

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0087111
Was subject withdrawn due to this event?
Beschrijving

Subject withdrawn

Datatype

text

Alias
UMLS CUI [1]
C0422727
Investigator's Signature
Beschrijving

Investigator's Signature

Datatype

text

Alias
UMLS CUI [1]
C2346576
Date of signature
Beschrijving

day month year

Datatype

date

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

Adverse Events

1 Formulieren
  1. StudyEvent: ODM
    1. Adverse Events
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Item Group
Adverse Event
C0877248 (UMLS CUI-1)
No adverse event
Item
If no adverse event, please mark box and sign form below.
boolean
Adverse Event
Item
Adverse Event
text
C0877248 (UMLS CUI [1])
Comment for GSK
Item
Comment for GSK
text
C0877248 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,3])
AE Onset Date
Item
AE Onset Date
date
C2985916 (UMLS CUI [1])
AE Onset Time
Item
AE Onset Time
time
C0449244 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
AE End Date
Item
AE End Date
date
C0806020 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
AE End Time
Item
AE End Time
time
C1522314 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item
Outcome
integer
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome
CL Item
Resolved (1)
CL Item
Ongoing (2)
Item
AE Event Course
integer
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
AE Event Course
Code List
AE Event Course
CL Item
Intermittent (1)
CL Item
Constant (2)
Number of Episodes
Item
If event course intermittent, please note the number of episodes
integer
C0877248 (UMLS CUI [1,1])
C4086638 (UMLS CUI [1,2])
Item
AE Intensity (maximum)
integer
C1710066 (UMLS CUI [1])
AE Intensity
Code List
AE Intensity (maximum)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Action taken with respect to investigational drug
integer
C2826626 (UMLS CUI [1])
Action taken with respect to investigational drug
Code List
Action taken with respect to investigational drug
CL Item
None (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Drug interrupted/restarted (4)
CL Item
Drug stopped (5)
Item
Relationship to Investigational Drug
integer
C1518404 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Relationship to Investigational Drug
Code List
Relationship to Investigational Drug
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 subject withdrawn due to this event?
text
C0422727 (UMLS CUI [1])
Subject withdrawn
Code List
Was 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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